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is an injectable siderophore cephalosporin discovered and being developed by Shionogi & Co., Ltd., Japan. As with other β-lactam antibiotics, the principal antibacterial\u002Fbactericidal activity of cefiderocol occurs by inhibition of Gram-negative bacterial cell wall synthesis by binding to penicillin binding proteins; however, it is unique in that it enters the bacterial periplasmic space as a result of its siderophore-like property and has enhanced stability to β-lactamases. The chemical structure of cefiderocol is similar to both ceftazidime and cefepime, which are third- and fourth-generation cephalosporins, respectively, but with high stability to a variety of β-lactamases, including AmpC and extended-spectrum β-lactamases (ESBLs). Cefiderocol has a pyrrolidinium group in the side chain at position 3 like cefepime and a carboxypropanoxyimino group in the side chain at position 7 of the cephem nucleus like ceftazidime. The major difference in the chemical structures of cefiderocol, ceftazidime and cefepime is the presence of a catechol group on the side chain at position 3. Together with the high stability to β-lactamases, including ESBLs, AmpC and carbapenemases, the microbiological activity of cefiderocol against aerobic Gram-negative bacilli is equal to or superior to that of ceftazidime-avibactam and meropenem, and it is active against a variety of Ambler class A, B, C and D β-lactamases. Cefiderocol is also more potent than both ceftazidime-avibactam and meropenem versus Acinetobacter baumannii, including meropenem non-susceptible and multidrug-resistant (MDR) isolates. Cefiderocol’s activity against meropenem–non-susceptible and Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriales is comparable or superior to ceftazidime-avibactam. Cefiderocol is also more potent than both ceftazidime-avibactam and meropenem against all resistance phenotypes of Pseudomonas aeruginosa and against Stenotrophomonas maltophilia. The current dosing regimen being used in phase III studies is 2 g administered intravenously every 8 h (q8 h) using a 3-h infusion. The pharmacokinetics of cefiderocol are best described by a three-compartment linear model. The mean plasma half-life (t½) was ~ 2.3 h, protein binding is 58%, and total drug clearance ranged from 4.6–6.0 L\u002Fh for both single- and multi-dose infusions and was primarily renally excreted unchanged (61–71%). Cefiderocol is primarily renally excreted unchanged and clearance correlates with creatinine clearance. Dosage adjustment is thus required for both augmented renal clearance and in patients with moderate to severe renal impairment. In vitro and in vivo pharmacodynamic studies have reported that as with other cephalosporins the pharmacodynamic index that best predicts clinical outcome is the percentage of time that free drug concentrations exceed the minimum inhibitory concentration (%fT > MIC). In vivo efficacy of cefiderocol has been studied in a variety of humanized drug exposure murine and rat models of infection utilizing a variety of MDR and extremely drug resistant strains. Cefiderocol has performed similarly to or has been superior to comparator agents, including ceftazidime and cefepime. A phase II prospective, multicenter, double-blind, randomized clinical trial assessed the safety and efficacy of cefiderocol 2000 mg q8 h versus imipenem\u002Fcilastatin 1000 mg q8 h, both administered intravenously for 7–14 days over 1 h, in the treatment of complicated urinary tract infection (cUTI, including pyelonephritis) or acute uncomplicated pyelonephritis in hospitalized adults. A total of 452 patients were initially enrolled in the study, with 303 in the cefiderocol arm and 149 in the imipenem\u002Fcilastatin arm. The primary outcome measure was a composite of clinical cure and microbiological eradication at the test-of-cure (TOC) visit, that is, 7 days after the end of treatment in the microbiological intent-to-treat (MITT) population. Secondary outcome measures included microbiological response per pathogen and per patient at early assessment (EA), end of treatment (EOT), TOC, and follow-up (FUP); clinical response per pathogen and per patient at EA, EOT, TOC, and FUP; plasma, urine and concentrations of cefiderocol; and the number of participants with adverse events. The composite of clinical and microbiological response rates was 72.6% (183\u002F252) for cefiderocol and 54.6% (65\u002F119) for imipenem\u002Fcilastatin in the MITT population. Clinical response rates per patient at the TOC visit were 89.7% (226\u002F252) for cefiderocol and 87.4% (104\u002F119) for imipenem\u002Fcilastatin in the MITT population. Microbiological eradication rates were 73.0% (184\u002F252) for cefiderocol and 56.3% (67\u002F119) for imipenem\u002Fcilastatin in the MITT population. Additionally, two phase III clinical trials are currently being conducted by Shionogi & Co., Ltd., Japan. The two trials are evaluating the efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens and evaluating the efficacy of cefiderocol in the treatment of adults with hospital-acquired bacterial pneumonia, ventilator-associated pneumonia or healthcare-associated pneumonia caused by Gram-negative pathogens. Cefiderocol appears to be well tolerated (minor reported adverse effects were gastrointestinal and phlebitis related), with a side effect profile that is comparable to other cephalosporin antimicrobials. Cefiderocol appears to be well positioned to help address the increasing number of infections caused by carbapenem-resistant and MDR Gram-negative bacilli, including ESBL- and carbapenemase-producing strains (including metallo-β-lactamase producers). A distinguishing feature of cefiderocol is its activity against resistant P. aeruginosa, A. baumannii, S. maltophilia and Burkholderia cepacia.",{"EN":231},"Cefiderocol: A Siderophore Cephalosporin with Activity Against Carbapenem-Resistant and Multidrug-Resistant Gram-Negative Bacilli",{"VOID":233},"[]",{"VOID":235},"Papp-Wallace KM, Endimiani A, Taracila MA, Bonomo RA. Carbapenems: past, present, and future. Antimicrob Agents Chemother. 2011;55:4943–60.\nGupta N, Limbago BM, Patel JB, Kallen AJ. Carbapenem-resistant Enterobacteriaceae: epidemiology and prevention. Clin Infect Dis. 2011;53:60–7.\nBuehrle DJ, Shields RK, Clarke LG, Potoski BA, Clancy CJ, Hong Nguyen M. Carbapenem-resistant Pseudomonas aeruginosa bacteremia: risk factors for mortality and microbiologic treatment failure. Antimicrob Agents Chemother. 2017;61:e01243-16.\nHiggins PG, Dammhayn C, Hackel M, Seifert H. Global spread of carbapenem-resistant Acinetobacter baumannii. J Antimicrob Chemother. 2009;65:233–8.\nWorld Health Organization. Antimicrobial resistance global report on surveillance [Internet]. 2014. Available from: http:\u002F\u002Fwww.who.int\u002Fdrugresistance\u002Fdocuments\u002Fsurveillancereport\u002Fen\u002F.\nZhanel GG, Chung P, Adam H, Zelenitsky S, Denisuik A, Schweizer F, et al. Ceftolozane\u002Ftazobactam: a novel cephalosporin\u002Fβ-lactamase inhibitor combination with activity against multidrug-resistant Gram-negative bacilli. Drugs. 2014;74:31–51.\nHackel MA, Tsuji M, Yamano Y, Echols R, Karlowsky JA, Sahm DF. In vitro activity of the siderophore cephalosporin, cefiderocol, against a recent collection of clinically relevant Gram-negative bacilli from North America and Europe, including carbapenem-nonsusceptible isolates (SIDERO-WT-2014 study). Antimicrob Agents Chemother. 2017;61:e00093-17.\nHackel MA, Tsuji M, Yamano Y, Echols R, Karlowsky JA, Sahm DF. In vitro activity of the siderophore cephalosporin, cefiderocol, against carbapenem-nonsusceptible and multidrug-resistant isolates of Gram-negative bacilli collected worldwide in 2014 to 2016. Antimicrob Agents Chemother. 2018;62:e01968-17.\nZhanel GG, Lawson CD, Adam H, Schweizer F, Zelenitsky S, Lagacé-Wiens PRS, et al. Ceftazidime-avibactam: a novel cephalosporin\u002Fβ-lactamase inhibitor combination. Drugs. 2013;73:159–77.\nCarlet J, Jarlier V, Harbarth S, Voss A, Goossens H, Pittet D. Ready for a world without antibiotics? The Pensières antibiotic resistance call to action. Antimicrob Resist Infect Control. 2012;1:11.\nKohira N, West J, Ito A, Ito-Horiyama T, Nakamura R, Sato T, et al. In vitro antimicrobial activity of a siderophore cephalosporin, S-649266, against Enterobacteriales clinical isolates, including carbapenem-resistant strains. Antimicrob Agents Chemother. 2016;60:729–34.\nPortsmouth S, van Veenhuyzen D, Echols R, Machida M, Arjona Ferreira JC, Ariyasu M, et al. Randomized controlled trial of a novel siderophore antibiotic cefiderocol versus imipenem\u002Fcilastatin for complicated urinary tract infections caused by Gram-negative uropathogens. Lancet Infect Dis. 2018;18(12):1319–28.\nDunn G. Ceftizoxime and other third-generation cephalosporins: structure-activity relationships. J Antimicrob Chemother Chemother. 1982;10(Suppl C):1–10.\nNeu HC. β-lactam antibiotics: structural relationships affecting in vitro activity and pharmacologic properties. Rev Infect Dis. 1986;8:237–59.\nIto A, Nishikawa T, Matsumoto S, Yoshizawa H, Sato T, Nakamura R, et al. Siderophore cephalosporin cefiderocol utilizes ferric iron transporter systems for antibacterial activity against Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2016;60:7396–401.\nIto A, Sato T, Ota M, Takemura M, Nishikawa T, Toba S, et al. In vitro antibacterial properties of cefiderocol, a novel siderophore cephalosporin, against Gram-negative bacteria. Antimicrob Agents Chemother. 2018;62:e01454-17.\nIto A, Toba S, Nishikawa T, Oota M, Kanazawa S, Fukuhara N, et al. S-649266, a novel siderophore cephalosporin: binding affinity to PBP and in vitro bactericidal activity. In: 25th Eur. Congr. Clin. Microbiol. Infect. Dis.; Copenhagen. 2015.\nIto-Horiyama T, Ishii Y, Ito A, Sato T, Nakamura R, Fukuhara N, et al. Stability of novel siderophore cephalosporin S-649266 against clinically relevant carbapenemases. Antimicrob Agents Chemother. 2016;60:4384–6.\nDomalaon R, Idowu T, Zhanel GG, Schweizer F. Antibiotic hybrids: the next generation of agents and adjuvants against Gram-negative pathogens? Clin Microbiol Rev. 2018;31:e00077-17.\nLeemans E, Fisher JF, Mobashery S. The β-lactam antibiotics: their future in the face of resistance. In: Marinelli F, Genilloud O, editors. Antimicrob. new old mol. Fight against multi-resistant Bact. Switzerland AG: Springer; 2014. p. 59–84.\nJacoby GA. AmpC beta-lactamases. Clin Microbiol Rev. 2009;22:161–82.\nBush K, Jacoby GA. Updated functional classification of β-lactamases. Antimicrob Agents Chemother. 2010;54:969–76.\nKazmierczak KM, Biedenbach DJ, Hackel M, Rabine S, De Jonge BLM, Bouchillon SK, et al. Global dissemination of bla KPC into bacterial species beyond Klebsiella pneumoniae and in vitro susceptibility to ceftazidime-avibactam and aztreonam-avibactam. Antimicrob Agents Chemother. 2016;60:4490–500.\nvan Duin D, Doi Y. The global epidemiology of carbapenemase-producing Enterobacteriaceae. Virulence. 2017;8:460–9.\nKöhler T, Michea-Hamzehpour M, Epp SF, Pechere JC. Carbapenem activities against Pseudomonas aeruginosa: respective contributions of OprD and efflux systems. Antimicrob Agents Chemother. 1999;43:424–7.\nIto A, Nishikawa T, Matsumoto S, Fukuhara N, Nakamura R, Tsuji M, et al. S-649266, a novel siderophore cephalosporin: II. Impact of active transport via iron regulated outer membrane proteins on resistance selection. In: 54th Intersci. Conf. Antimicrob. Agents Chemother.; Washington, DC. 2014.\nIto A, Toba S, Nishikawa T, Kohira N, Sato T, Tsuji M, et al. Contribution of active iron transporters and binding ability to penicillin binding proteins of cefiderocol (S-649266) to its antibacterial\u002Fbactericidal activity against Klebsiella pneumoniae and Escherichia coli. In: ASM Microbe 2017; New Orleans. 2017.\nOlofsson SK, Cars O. Optimizing drug exposure to minimize selection of antibiotic resistance. Clin Infect Dis. 2007;45:S129–36.\nAndersson DI. Improving predictions of the risk of resistance development against new and old antibiotics. Clin Microbiol Infect. 2015;21:894–8.\nKohira N, Nakamura R, Ito A, Nishikawa T, Ota M, Sato T, et al. Resistance acquisition studies of cefiderocol by serial passage and in vitro pharmacodynamic model under human simulated exposure. In: ASM Microbe 2018; Atlanta. 2018.\nTsuji M, Kazmierczak K, Hackel M, Echols R, Yamano Y, Sahm D. Cefiderocol (S-649266) susceptibility against globally isolated meropenem non-susceptible Gram-negative bacteria containing serine and metallo-carbapenemase genes. In: ASM Microbe 2018; Atlanta. 2018.\nYamano Y, Tsuji M, Hackel MA, Echols R, Sahm DF. In vitro activity of cefiderocol against globally collected carbapenem resistant Gram-negative bacteria including isolates resistant to ceftazidime\u002Favibactam, ceftolozane\u002Ftazobactam and colistin: SIDERO-CR-2014\u002F2016 study. In: 27th Eur. Congr. Clin. Microbiol. Infect. Dis.; Vienna. 2017.\nTsuji M, Hackel M, Yamano Y, Echols R, Sahm DF. Surveillance of cefiderocol in vitro activity against Gram-negative clinical isolates collected in Europe: SIDERO-WT-2014. In: 27th Eur. Congr. Clin. Microbiol. Infect. Dis.; Vienna. 2017.\nTsuji M, Hackel MA, Echols R, Yamano Y, Sahm DF. Global surveillance of cefiderocol (S-649266) against Gram-negative clinical strains collected in North America: SIDERO-WT-2014. In: ASM Microbe 2017; New Orleans. 2017.\nHackel M, Tsuji M, Echols R, Sahm D. In vitro antibacterial activity of cefiderocol (S-649266) against Gram-negative clinical strains collected in North America and Europe (SIDERO-WT-2014 study). In: IDWeek; New Orleans. 2016.\nTsuji M, Yamaguchi T, Nakamura R, Kanazawa S, Ito-Horiyama T, Sato T, et al. S-649266, a novel siderophore cephalosporin: In vitro activity against Gram-negative bacteria isolated in Japan including carbapenem resistant strains. In: IDWeek; San Diego. 2015.\nTsuji M, Hackel M, Echols R, Yamano Y, Sahm DF. In vitro activity of cefiderocol against globally collected carbapenem-resistant Gram-negative bacteria isolated from urinary tract source: SIDERO-CR-2014\u002F2016. In: IDWeek; San Diego. 2017.\nIto A, Kohira N, Yoshizawa H, Nakamura R, Tsuji M, Yamano Y, et al. S-649266, a novel siderophore cephalosporin: I. In vitro activity against Gram-negative bacteria including multidrug-resistant strains. In: 54th Intersci. Conf. Antimicrob. Agents Chemother; Washington, DC. 2014.\nTsuji M, Kohira N, Nakamura R, Sato T, Yamano Y. S-649266, a novel siderophore cephalosporin: in vitro combination effect of S-649266 and other antibiotics against Gram-negative bacteria. In: 26th Eur. Congr. Clin. Microbiol. Infect. Dis.; Amsterdam. 2016.\nJacobs MR, Abdelhamed AM, Good CE, Rhoads DD, Hujer KM, Hujer AM, et al. In vitro activity of cefiderocol (S-649266), a siderophore cephalosporin, against Enterobacteriaceae with defined extended-spectrum β-lactamases and carbapenemases. In: IDWeek; San Francisco. 2018.\nTsuji M, Hackel M, Echols R, Yamano Y, Sahm D. In vitro activity of cefiderocol against Gram-negative clinical isolates collected in North America from urinary tract source: SIDERO-WT-2014\u002FSIDERO-WT-2015. In: IDWeek; San Diego. 2017.\nFalagas M, Skalidis T, Vardakas K, Legakis N, Tsiplakou S, Papaioannou V, et al. Activity of cefiderocol (S-649266) against carbapenem-resistant Gram-negative bacteria collected from inpatients in Greek hospitals. J Antimicrob Chemother. 2017;72:1704–8.\nDobias J, Dénervaud-Tendon V, Poirel L, Nordmann P. Activity of the novel siderophore cephalosporin cefiderocol against multidrug-resistant Gram-negative pathogens. Eur J Clin Microbiol Infect Dis. 2017;36:2319–27.\nTsuji M, Hackel M, Yamano Y, Echols R, Sahm DF. The in vitro activity of cefiderocol, a novel siderophore cephalosporin, against a global collection of Stenotrophomonas maltophilia. In: 27th Eur. Congr. Clin. Microbiol. Infect. Dis.; Vienna. 2017.\nShields RK, Kline EG, Jones CE, Mettus RT, Clancy CJ, Hong Nguyen M, et al. Cefiderocol minimum inhibitory concentrations against ceftazidime-avibactam susceptible and resistant carbapenem-resistant Enterobacteriaceae. In: ASM Microbe 2018; Atlanta. 2018.\nClinical and Laboratory Standards Institute (CLSI). Performance standards for antimicrobial susceptibility testing. M100, 28th ed; Wayne. 2018.\nInternational Organization for Standardization. ISO 20776-1:2006. Clinical laboratory testing and in vitro diagnostic test systems—susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices—part 1: reference method for testing the in vitro. 2006.\nIto A, Ishibashi N, Kitanishi K, Osaki H, Sato T, Tsuji M, et al. Contribution of chelating ability with iron(III) and the utilization of iron transporters through the outer membrane to the in vitro activity of cefiderocol (S-649266) against Pseudomonas aeruginosa. In: ASM Microbe 2017; New Orleans. 2017.\nSaisho Y, Katsube T, White S, Fukase H, Shimada J. Pharmacokinetics, safety, and tolerability of cefiderocol, a novel siderophore cephalosporin for Gram-negative bacteria, in healthy subjects. Antimicrob Agents Chemother. 2018;62:e02163-17.\nKatsube T, Echols R, Arjona Ferreira JC, Krenz HK, Berg JK, Galloway C. Cefiderocol, a siderophore cephalosporin for Gram-negative bacterial infections: pharmacokinetics and safety in subjects with renal impairment. J Clin Pharmacol. 2017;57:584–91.\nKatsube T, Wajima T, Ishibashi T, Arjona Ferreira JC, Echols R. Pharmacokinetic\u002Fpharmacodynamic modeling and simulation of cefiderocol, a parenteral siderophore cephalosporin, for dose adjustment based on renal function. Antimicrob Agents Chemother. 2017;61:e01381-16.\nKawaguchi N, Katsube T, Echols R, Wajima T. Population pharmacokinetic analysis of cefiderocol, a parenteral siderophore cephalosporin, in healthy subjects, subjects with various degrees of renal function, and patients with complicated urinary tract infection or acute uncomplicated pyelonephritis. Antimicrob Agents Chemother. 2018;62:e01391-17.\nNakamura R, Toba S, Ito A, Tsuji M, Yamano Y, Shimada J. S-649266, a novel siderophore cephalosporin: V. Pharmacodynamic assessment in murine thigh infection models. In: 54th Intersci. Conf. Antimicrob. Agents Chemother.; Washington, DC. 2014.\nHoriyama T, Toba S, Nakamura R, Tsuji M, Yamano Y, Shimada J. S-649266, a novel siderophore cephalosporin: VI. Magnitude of PK\u002FPD parameter required for efficacy in murine lung infection model. In: 54th Intersci. Conf. Antimicrob. Agents Chemother.; Washington, DC. 2014.\nHoriyama T, Toba S, Nakamura R, Tsuji M, Yamano Y, Shimada J. S-649266, a novel siderophore cephalosporin: VII. Magnitude of PK\u002FPD parameter required for efficacy in murine thigh infection model. In: 54th Intersci. Conf. Antimicrob. Agents Chemother.; Washington, DC. 2014.\nGhazi IM, Monogue ML, Tsuji M, Nicolau DP. Pharmacodynamics of cefiderocol, a novel siderophore cephalosporin, in a Pseudomonas aeruginosa neutropenic murine thigh model. Int J Antimicrob Agents. 2018;51:206–12.\nMonogue ML, Tsuji M, Yamano Y, Echols R, Nicolaua DP. Efficacy of humanized exposures of cefiderocol (S-649266) against a diverse population of Gram-negative bacteria in a murine thigh infection model. Antimicrob Agents Chemother. 2017;61:e01022-17.\nMatsumoto S, Singley CM, Hoover J, Nakamura R, Echols R, Rittenhouse S, et al. Efficacy of cefiderocol against carbapenem-resistant Gram-negative bacilli in immunocompetent-rat respiratory tract infection models recreating human plasma pharmacokinetics. Antimicrob Agents Chemother. 2017;61:e00700–17.\nIto A, Kohira N, Bouchillon SK, West J, Rittenhouse S, Sader HS, et al. In vitro antimicrobial activity of S-649266, a catechol-substituted siderophore cephalosporin, when tested against non-fermenting Gram-negative bacteria. J Antimicrob Chemother. 2016;71:670–7.\nHoriyama T, Singley CM, Nakamura R, Tsuji M, Echols R, Rittenhouse S, et al. S-649266, a novel siderophore cephalosporin: VIII. Efficacy against Pseudomonas aeruginosa and Acinetobacter baumannii in rat lung infection model with humanized exposure profile of 2 g dose with 1 h infusion. In: 54th Intersci. Conf. Antimicrob. Agents Chemother.; Washington, DC. 2014.\nNakamura R, Toba S, Tsuji M, Yamano Y, Shimada J. S-649266, a novel siderophore cephalosporin: IV. In vivo efficacy in various murine infection models. In: 54th Intersci. Conf. Antimicrob. Agents Chemother.; Washington, DC. 2014.\nGhazi IM, Monogue ML, Tsuji M, Nicolau DP. Humanized exposures of cefiderocol, a siderophore cephalosporin, display sustained in vivo activity against siderophore-resistant Pseudomonas aeruginosa. Pharmacology. 2018;101:278–84.\nPortsmouth S, van Veenhuyzen D, Echols R, Machida M, Arjona Ferreira JC, Ariyasu M, et al. 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In well controlled trials in surgical venous thrombosis (DVT), enoxaparin has demonstrated prophylactic efficacy against venographically confirmed DVT at least equal to that observed with unfractionated heparin. Efficacy has also been demonstrated in patients at moderate risk and in limited investigations using 125I-fibrinogen scanning in nonsurgical patients at risk of DVT; in addition, enoxaparin appears to provide effective treatment of established DVT. In clinical studies, enoxaparin has also prevented coagulation of extracorporeal circulation, maintaining the patency of the circuit in patients undergoing haemodialysis. Thus, enoxaparin represents an effective alternative in the prophylaxis and treatment of thrombosis, with the convenience of less frequent administration than unfractionated heparin and the possible advantage of a lesser propensity for bleeding complications. Enoxaparin, in common with other low molecular weight heparins, was developed in response to the observation of an apparently greater separation of its antithrombotic and haemorrhagic dose ranges, relative to unfractionated heparin; the experimental basis of this dissociation is at present incompletely understood. The low molecular weight heparins are pharmacologically distinct agents with different physicochemical properties and unique profiles. A number of their pharmacological properties have been determined to be directly proportional to their molecular weight, including affinity for antithrombin III, anti-factor Xa and anti-thrombin (anti-factor Ha) activities, and susceptibility to neutralisation by platelet factor 4 and other heparin binding proteins. Enoxaparin is prepared from heparin by benzylation followed by alkaline depolymerisation. The apparent mean molecular weight of enoxaparin, as determined by high performance liquid chromatography with ultraviolet detection, is 3.8kD. The anti-factor Xa activity of enoxaparin (units\u002Fmg) is less than that of unfractionated heparin. However, for equivalent anti-factor Xa activity, enoxaparin has up to 5 times less effect on thrombin. A ratio of 3.6 for amidolytic antifactor Xa activity to anti-thrombin activity in plasma has been reported for enoxaparin, with the value for unfractionated heparin defined as unity. In a modified stasis venous thrombosis model in the rabbit, the dose producing 50% effect (ED50) for in vivo antithrombotic activity of enoxaparin, after intravenous administration, was determined to be 58 vs 32 μg\u002Fkg for unfractionated heparin. A significantly smaller extent of blood loss with enoxaparin than with unfractionated heparin has been apparent in studies employing a rabbit ear model. Most in vitro and ex vivo studies in animal and human platelet rich plasma, primarily using collagen as inducer, indicate a somewhat lesser effect of enoxaparin to that of unfractionated heparin on platelet aggregation, and these observations provide the basis for one postulated mechanism of the apparently lesser haemorrhagic effect of enoxaparin relative to unfractionated heparin in animal models. The full clinical significance of these findings remains to be determined. Enoxaparin is highly and predictably absorbed after subcutaneous administration. Studies in volunteers indicate that absorption of enoxaparin is linear within a subcutaneous dose range of 20 to 80mg. The absolute bioavailability of subcutaneous enoxaparin, in terms of anti-factor Xa activity, is estimated to be 9.1%, approximately 3 times higher than that of low dose unfractionated heparin. Estimates of the volume of distribution of enoxaparin in volunteers range between 5.2 and 9.3L. Enoxaparin does not appear to cross the placenta to any significant extent. While the available data are somewhat incomplete, the primary route of elimination of enoxaparin appears to be renal, in contrast with unfractionated heparin, for which additional saturable mechanisms of elimination are significant. Thus, enoxaparin appears to possess the advantage of dose-independent elimination. Total body clearance of enoxaparin in volunteers is rather low, published estimates ranging between 0.83 and 1.86 L\u002Fh. The terminal phase elimination half-life of enoxaparin, based on anti-factor Xa activity, has ranged between 3 and 6 hours following subcutaneous administration to volunteers. Although there are discordant findings in the literature, it appears that in the presence of chronic severe renal failure, enoxaparin total clearance may be halved and elimination half-life doubled. In total hip replacement surgery, a model of high risk for postoperative DVT, and other orthopaedic surgery, the incidence of total venographically confirmed DVT following administration of subcutaneous enoxaparin at a dosage of 40mg once daily, initiated 12 hours preoper-atively (8 hours preoperatively in a single study), has ranged from 6.5 to 12.5%; with a regimen of 30mg twice daily initiated postoperatively, the range was 6.0 to 19.5%. These figures compare with rates for placebo of between 51 and 65%, for unfractionated heparin of between 23 and 25%, and for dextran 70 of 22% in these studies. Similarly, rates of proximal DVT of between 4.0 and 7.5% for enoxaparin 40mg once daily (‘preoperative’ regimen), 5.4 and 6.0% for enoxaparin 30mg twice daily (‘postoperative’ regimen), 23% for placebo, and between 7 and 19% for unfractionated heparin were observed. A 10mg once daily regimen was found to be minimally effective, with rates of total DVT of 31%, and of proximal DVT of 15%, being observed. Studies have variously used regimens initiating enoxaparin prophylaxis either pre-or postoperatively, as well as regimens in which a small perioperative single dose was administered, with a subsequent higher-dose ‘maintenance’ regimen. The different administration regimens reflect differences in clinical practice in Europe and North America. A large-scale postmarketing study in 8738 patients undergoing general surgery treated with enoxaparin 20mg once daily for 7 days evinced an incidence of total DVT, albeit identified by clinical signs only, of 0.16%. Other studies using the same dosage reported a similar rate of total DVT detected by [125I]-fibrinogen scanning (2.8 to 3.8%) to that seen with unfractionated heparin 5000U 3 times daily (2.7 to 7.6%) or enoxaparin 40 or 60mg once daily (2.8 and 2.9%, respectively). Enoxaparin prophylaxis at a dosage of 60mg once daily was also effective in preventing DVT (detected by [125I]-fibrinogen scanning) in medical patients in one placebo-controlled study. In investigations in patients with venographically-confirmed recent DVT, treatment with subcutaneous enoxaparin (dosages up to 2 mg\u002Fkg\u002Fday) has produced significant reductions in venographic scores, without significant haemorrhagic complications. Enoxaparin (dosage around 1 mg\u002Fkg) has been usefully employed in preventing coagulation of the dialysis circuit in patients undergoing haemodialysis, without the occurrence of haemorrhagic episodes. In a pilot study enoxaparin provided effective anticoagulant treatment in one small series of patients with heparin-induced thrombocytopenia. Data from clinical trials appear to indicate a lesser potential for haemorrhagic complications with enoxaparin than with unfractionated heparin. While it is not certain that sample sizes were sufficiently large to detect a significant difference, in placebo-controlled trials in orthopaedic surgery, the incidence of bleeding episodes following postoperative enoxaparin administration (2 to 6.1%) was similar to that observed with placebo (0 to 7.7%). In a large-scale postmarketing survey in general surgery, excessive bleeding considered related to enoxaparin therapy (20mg once daily) was observed in 0.6% of patients. However, the findings from other trials in general surgery indicate that some degree of dose-dependence in the rate of bleeding complications may be observed. Ecchymoses may develop at the site of injection of enoxaparin, but their incidence is likely to be considerably less than with unfractionated heparin because of a reduced frequency of administration. There are at present no reports from clinical studies of thrombocytopenia occurring in patients receiving enoxaparin; however, the possibility of its occurrence with enoxaparin and other low molecular weight heparins cannot be excluded, and the potential risk remains to be quantified in relation to the substantial risk apparent for unfractionated heparin. In prevention of postoperative DVT in patients undergoing orthopaedic surgery, subcutaneous enoxaparin doses of 40mg once daily (from 12 hours preoperatively) are employed in Europe, while a dosage of 30mg twice daily (from 12 to 24 hours postoperatively) has been used in North America; in general surgery and in ‘moderate risk’ patients dosages of 20mg once daily have also been employed. Enoxaparin 2 mg\u002Fkg\u002Fday is effective in the treatment of established DVT, while 1 mg\u002Fkg appears to be effective in preventing coagulation of the extracorporeal circuit in patients undergoing haemodialysis. For daily dosages higher than 60mg, the elimination of enoxaparin may be prolonged in patients with severe renal dysfunction; however, an appropriate nomogram for dosage reduction has not yet been devised.",{"EN":557},{"VOID":233},{"VOID":564},"Abildgaard U, Lindahl AK, Sandset PM. Heparin requires both antithrombin and extrinsic pathway inhibitor for its anticoagulant effect in human blood. Haemostasis 21: 254–257, 1991\nAiach M, Michaud A, Balian J-L, Lefebvre M, Woler M, et al. A new low molecular weight heparin derivative. In vitro and in vivo studies. Thrombosis Research 31: 611–621, 1983\nAndersson L-O, Barrowcliffe TW, Holmer E, Johnson EA, Sims GEC. Anticoagulant properties of heparin fractionated by affinity chromatography on matrix-bound antithrombin III and by gel filtration. Thrombosis Research 9: 575–583, 1976\nAndrew M, Cade J, Buchanan MR, Cerskus AL, Jefferies A. et al. Low molecular weight heparin does not cross the placenta. Abstract. 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Annales Françaises d’Anesthésie et de Réanimation 9: 331–337, 1990\nKandrotas RJ. Heparin pharmacokinetics and pharmacodynamics. Clinical Pharmacokinetics 22: 359–374, 1992\nKelton JG. Heparin-induced thrombocytopenia. Haemostasis 16: 173–186, 1986\nLane DA, Denton J, Flynn AM, Thunberg L, Lindahl U. Anticoagulant activities of heparin oligosaccharides and their neutralization by platelet factor 4. Biochemistry Journal 218: 725–732, 1984\nLane DA, Pejler GH, Flynn AM, Thompson EA, Lindahl U. Neutralization of heparin-related saccharides by histidine-rich glycoprotein and platelet factor 4. Journal of Biological Chemistry 261: 3980–3986, 1986\nLaurent TC, Tengblad A, Thunberg L, Hook M, Lindhai U. The molecular-weight-dependence of the anti-coagulant activity of heparin. Biochemical Journal 175: 691–701, 1978\nLeclerc J, Geerts W, Desjardins L, Jobin F, Laroche F, et al. Prevention of deep vein thrombosis after major knee surgery — a randomized, double-blind trial comparing a low molecular weight heparin fragment (enoxaparin) to placebo. Thrombosis and Haemostasis 67: 417–423, 1992\nLe Gagneux F, Steg A, Le Guillou M. Subcutaneous enoxaparine (Lovenox®) versus placebo for preventing deep vein thrombosis (DVT) after transurethral prostatectomy (TUP). Thrombosis and Haemostasis 58: 116, 1987\nLevine MN, Hirsh J, Gent M, Turpie AG, Leclerc J, et al. Prevention of deep vein thrombosis after elective hip surgery. A randomised trial comparing low molecular weight heparin with standard unfractionated heparin. Annals of Internal Medicine 114:545–551, 1991\nLevine MN, Planès A, Hirsh J, Goodyear M, Vochelle N, et al. The relationship between anti-factor Xa level and clinical outcome in patients receiving enoxaparine low molecular weight heparin to prevent deep vein thrombosis after hip replacement. Thrombosis and Haemostasis 62: 940–944, 1989\nLindahl AK, Abildgaard U, Larsen ML, Aamodt L-M, Nordfang et al. Extrinsic pathway inhibitor (EPI) and the post-heparin anticoagulant effect in tissue thromboplastin induced coagulation. Thrombosis Research 14 (Suppl): 39–48, 1991\nLindahl U, Thunberg L, Backstrom G, Riesenfeld J, Nordling K, et al. Extension and structural variability of the antithrombin-binding sequence in heparin. Journal of Biological Chemistry 259: 368–376, 1984\nMarder VJ. Variations of heparin therapy for thromboembolic disease. Medical Clinics of North America 58: 1121–1128, 1974\nMessmpre HL, Griffin B, Fareed J, Coyne E, Seghatchian J. In vitro studies of the interaction of heparin, low molecular weight heparin and heparinoids with platelets. Annals of the New York Academy of Sciences 556: 217–232, 1989\nMirshahi M, Soria J, Neuhart E, Steg PG, Jacob P, et al. Effect of heparin and enoxaparin on platelet interaction with fibrin clots. Thrombosis Research 65: 187–191, 1992\nModig J, Borg T, Karlström G, Maripuu E, Sahlstedt Thromboembolism after total hip replacement: role of epidural and general anesthesia. Anesthesia and Analgesia 62: 174–180, 1983\nMohr VD, Lenz J. Heparin-assoziierte Thrombocytopenie, Thrombose und Embolie. Unerwünschte Wirkung der Throm-boembolieprophylaxe mit dem niedermolekularen Heparin Enoxaparin? Chirurg 62: 686–690, 1991\nNielson CP, Cusack BJ, Vestal RE. Geriatric clinical pharmacology and therapeutics. In Speight TM (Ed.) Avery’s Drug Treatment. 3rd edition (1987), ADIS Press Ltd, Auckland\nOckelford PA, Carter CJ, Mitchell L, Hirsh J. Discordance between the anti-Xa activity and the antithrombotic activity of an ultra-low molecular weight heparin fraction. Thrombosis Research 28: 401–409, 1982\nOfosu FA, Leclerc J, Blaichman MA. The low molecular weight heparin enoxaparin moderates factor VII and prothrombin consumption associated with elective knee surgery. Abstract. Thrombosis and Haemostasis 65: 1298, 1991\nOosta GM, Gardner WT, Beeler DL, Rosenberg RD. Multiple functional domains of the heparin molecule. Proceedings of the National Academy of Sciences, USA 78: 829–833, 1981\nPetitou M. Synthetic heparin fragments: new and efficient tools for the study of heparin and its interactions. Nouvelle Revue Française d’Hématologie 26: 221–226, 1984\nPetitou M, Duchaussoy P, Lederman I, Choay J, Sinay P. Binding of heparin to antithrombin III. A chemical proof of the critical role played by a 3-sulfated 2-amino-2-deoxy-D-glucose residue. Carbohydrate Research 179: 163–172, 1988\nPitney WR. Heparin therapy and its laboratory control. British Journal of Haematology 18: 499–502, 1970\nPlanès A, Vochelle N, Fagola M, Bellaud M, Féret J, et al. Efficacy and safety of a perioperative enoxaparin regimen in total hip replacement under various anesthesias. American Journal of Surgery 161: 525–531, 1991a\nPlanés A, Vochelle N, Fagola M, Bellaud M, Féret J, et al. Once-daily dosing of enoxaparin (a low molecular weight heparin) in prevention of deep vein thrombosis after total hip replacement. Acta Chirurgica Scandinavica 556 (Suppl): 108–115, 1990\nPlanès A, Vochelle N, Bouthier J, Fagola M, Bellaud M. Use of enoxaparin, a low molecular weight heparin, in elective hip surgery. Seminars in Thrombosis and Hemostasis 17 (Suppl. 3): 296–303, 1991c\nPlanès A, Vochelle N, Fagola M, Féret J, Bellaud M. The effect of low molecular weight heparin with spinal and general anaesthesia. Journal of Bone and Joint Surgery 73: 418–422, 1991b\nPlanès A, Vochelle N, Ferru J, Przyrowski D, Clerc J, et al. Enoxaparine low molecular weight heparin: its use in the prevention of deep venous thrombosis following total hip replacement. Haemostasis 16: 152–158, 1986\nPlanés A, Vochelle N, Mazas F, Mansat Zucman J, et al. Prevention of postoperative venous thrombosis: a randomized trial comparing unfractionated heparin with low molecular weight heparin in patients undergoing total hip replacement. Thrombosis and Haemostasis 60: 407–410, 1988\nPouzol P, Dechelette E, Jurkovitz C, Kuentz F, Polack B. L’énoxaparine dans la prévention de la thrombose du circuit extracorporel de dialyse des insuffisants rénaux chroniques. Revue de Médecine Interne 9: 321–326, 1988\nPouzol P, Polack B, Dechelette E, Jurkovitz C, Cusin E. Activités biologiques de l’énoxaparine (PK 10 169) en hémodialyse. Étude de dose. Journal des Maladies Vasculaires 12: 108–110, 1987\nRobitaille D, Leclerc JR, Laberge R, Sahab P, Atkinson S, et al. Cardiopulmonary bypass with a low-molecular-weight heparin fraction (enoxaparin) in a patient with a history of heparin-associated thrombocytopenia. Correspondence. Journal of Thoracic and Cardiovascular Surgery 103: 597–599, 1992\nRosenberg RD, Damus PS. The purification and mechanism of action of human antithrombin-heparin cofactor. Journal of Biological Chemistry 248: 6490–6505, 1973\nRosenberg RD, Jordon RE, Favreau LV, Lam LH. Highly active heparin species with multiple binding sites for antithrombin. Biochemical and Biophysical Research Communications 86: 1319–1324, 1979\nSamama CM, Mouren S, Bridel MP, Combe S, Koskas F, et al. Utilisation per et postopératoire d’une héparine de bas poids moléculaire en chirurgie vasculaire périphérique. Annales Françaises d’Anesthésie et de Réanimation 9: 102–105, 1990\nSamama M, Bernard P, Bonnardot JP, Combe-Tamzali S, Lanson Y, et al. Low molecular weight heparin compared with unfractionated heparin in prevention of postoperative thrombosis. British Journal of Surgery 75: 128–131, 1988\nSamama M, Combe-Tamzali S. Prevention of thromboembolic disease in general surgery with enoxaparin. British Journal of Clinical Practice 43: (Suppl.): 9–17, 1989\nSamama MM, Combe S, Horellou MH, Augras D, True JB, et al. Anti Xa activity and prothrombinase inhibition in patients treated with two different doses of enoxaparin in gynecologic surgery. Thrombosis Research (Suppl. 14): 29–37, 1991\nSandset PM, Abildgaard U, Larsen ML. Heparin induces release of extrinsic coagulation pathway inhibitor (EPI). Thrombosis Research 50: 803–813, 1988\nSchoen P, Lindhout T, Franssen J, Hemker HC. Low molecular weight heparin-catalyzed inactivation of factor Xa and thrombin by antithrombin III — effect of platelet factor 4. Thrombosis and Haemostasis 66: 435–441, 1991\nSimonneau G, TVPÉNOX Study Group. Subcutaneous fixed dose of enoxaparine (E) versus intravenous adjusted dose of unfractionated heparin (UH) in the treatment of deep venous thrombosis (DVT). Thrombosis and Haemostasis 65: 754, 1991\nSpiro TE, Enoxaparin Clinical Trial Group. A randomized, trial of enoxaparin administered post operatively for the prevention of deep vein thrombosis following elective hip replacement surgery. Abstract. Thrombosis and Haemostasis 65: 927, 1991\nTeien AN, Lie M. Heparin assay in plasma: a comparison of five clotting methods. Thrombosis Research 7: 777–788, 1975\nThunberg L, Backstrom G, Lindahl U. Further characterisation of antithrombin-binding sequence in heparin. Carbohydrate Research 100: 393–410, 1982\nTriplett DA, Harms CS, Koepke JA. The effect of heparin on the activated partial thromboplastin time. American Journal of Clinical Pathology 70 (Suppl 3): 556–559, 1978\nTurpie AGG, Levine MN, Hirsh J, Carter CJ, Jay RM, et al. A randomized controlled trial of a low-molecular-weight heparin (enoxaparin) to prevent deep-vein thrombosis in patients undergoing elective hip surgery. New England Journal of Medicine 315: 925–929, 1986\nTurpie AGG. Efficacy of a postoperative regimen of enoxaparin in deep vein thrombosis prophylaxis. American Journal of Surgery 161: 532–536, 1991\nvan Rijn JLML, Trillou M, Mardiguian J, Tobelem G, Caen J. Selective binding of heparins to human endothelial cells. Implications for pharmacokinetics. Thrombosis Research 45: 211–222, 1987\nVerstraete M. Pharmacotherapeutic aspects of unfractionated and low molecular weight heparins. Drugs 40: 498–530, 1990\nVerstraete M, Boogaerts MA. Haematological disorders. In Speight TM (Ed.) Avery’s drug treatment, 3rd ed. pp. 958–1022, ADIS Press Ltd, Auckland, 1987\nVinazzer H, Woler M. A new low molecular weight heparin fragment (PK 10169): in vitro and in vivo studies. Thrombosis Research 40: 135–146, 1985\nVitoux J-F, Fiessinger J-N, Roncato M, Pernes J-M, Brenot P, et al. Long-term treatment of acute deep venous thrombosis with low-molecular-weight heparin derivative. Correspondence. Journal of the American Medical Association 259: 1180–1181, 1988\nWalenga JM, Bara L, Samama MM, Fareed J. Amidolytic anti-factor Xa assay in the laboratory evaluation of heparin and low molecular weight fractions. Seminars in Thrombosis and Hemostasis 11: 100–107, 1985\nWalenga JM, Fareed J, Hoppensteadt DA. In vitro coagulant and amidolytic methods for evaluating the activity of heparin and a low molecular weight derivative (PK 10169). Seminars in Thrombosis and Hemostasis 11: 17–25, 1985b\nWalenga JM, Hoppensteadt D, Fareed J. Laboratory monitoring of the clinical effects of low molecular weight heparins. Thrombosis Research 14 (Suppl.): 49–62, 1991\nWalz DA, Hung GL. In vivo studies on the binding of heparin and its fractions with platelet factor 4. Seminars in Thrombosis and Hemostasis 11: 40–47, 1985\nWhittle BJR, Kauffman GL, Moncada S. Hemostatic mechanisms, independent of platelet aggregation, arrest gastric mucosal bleeding. Proceedings of the National Academy of Science, USA 83: 5683–5687, 1986\nWille-JØrgertsen P. Prophylaxis of postoperative thromboembolism. Laegeforeningens Forlag, Copenhagen, 1991\nWynckel A, Bernieh B, Toupance O, N’Guyen PH, Wong T, et al. Guidelines to the use of enoxaparin in slow continuous hemodialysis. Contributions to Nephrology 93: 221–224, 1991\nYin E. Appraisal of clot-based and amidolytic anti Xa methods for the monitoring of heparin and its derivatives. Seminars in Thrombosis and Hemostasis 11: 243–245, 1985\nYin ET, Wessler S, Butler J. Plasma heparin: a unique, practical, submicrogram sensitive assay. 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Development of clonidine-tolerance in the rat vas deferens: cross-tolerance to other presynaptic inhibitory agents. Life Sciences 30: 285–292, 1982\nJonkman FAM, Man PW, Thoolen MJMC, van Zwieten PA. Location of the clonidine withdrawal tachycardia in rats. Journal of Pharmacy and Pharmacology 37: 580–582, 1985\nJonkman FAM, Thoolen MJMC, Wilffert B, de Jonge A, Timmermans PBMWM, et al. Effect of salbutamol and the PDE-inhibitor RA 642 on the clonidine withdrawal syndrome in rats. Journal of Autonomic Pharmacology 4: 199–206, 1984\nThoolen MJMC, Hendriks JCA, Timmermans PBMWM, van Zwieten PA. Precipitation by yohimbine of the withdrawal syndromes of clonidine, guanfacine and methyldopa in the spontaneously hypertensive rat. Journal of Cardiovascular Pharmacology 5: 224–228, 1983\nThoolen MJMC, Timmermans PBMWM, van Zwieten PA. Withdrawal syndrome after continuous infusion of clonidine in normotensive rats. Journal of Pharmacy and Pharmacology 33: 232–235, 1981",{"VOID":768},"10.2165\u002F00003495-199000404-00012","2024-06-24T22:20:12.020+00:00","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.2165\u002F00003495-199000404-00012",[772,787],{"id":773,"sortIndex":85,"researcher":23,"roles":774,"affiliations":775,"properties":784,"displayName":786,"givenName":23,"familyName":23},"328938de-8181-4f7d-bbe3-f4e0f045048c",[244],[776],{"id":777,"sortIndex":85,"affiliation":778,"properties":23},"1e6746f6-1085-4e3c-b531-81c7d96d38b4",{"id":777,"createTime":23,"updateTime":23,"relativeEntities":779,"slug":23,"properties":780,"entityType":23,"verifyStatus":23,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":23,"url":23,"parentIds":783,"statistic":23},[],{"title":781},{"VI":782},"Departments of Pharmacotherapy and Cardiology, Academic Medical Centre, University of Amsterdam, AZ Amsterdam, The Netherlands",[],{"title":785},{"VI":786},"Fokke A. M. Jonkman",{"id":788,"sortIndex":89,"researcher":23,"roles":789,"affiliations":790,"properties":797,"displayName":799,"givenName":23,"familyName":23},"108b7c50-a3f2-4230-bddd-815463f7508b",[244],[791],{"id":777,"sortIndex":85,"affiliation":792,"properties":23},{"id":777,"createTime":23,"updateTime":23,"relativeEntities":793,"slug":23,"properties":794,"entityType":23,"verifyStatus":23,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":23,"url":23,"parentIds":796,"statistic":23},[],{"title":795},{"VI":782},[],{"title":798},{"VI":799},"Pieter A. van Zwieten",{"url":770,"publisher":801,"properties":844},{"id":6,"createTime":7,"updateTime":8,"relativeEntities":802,"slug":10,"properties":803,"entityType":21,"verifyStatus":22,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":24,"subjectFields":808,"manageAffiliations":813,"indexDatabases":824,"url":83,"thumbnailPath":23,"statistic":839,"gsStatistic":23,"type":23,"analyzePriority":23},[],{"country":804,"eissn":805,"issn":806,"title":807},{"VOID":13},{"VOID":15},{"VOID":17},{"EN":10},[809],{"id":27,"createTime":23,"updateTime":23,"relativeEntities":810,"label":811,"description":812,"parentId":23,"standard":23,"scholarHubFieldId":23},[],{"EN":30},{},[814,819],{"id":34,"createTime":23,"updateTime":23,"relativeEntities":815,"slug":23,"properties":816,"entityType":23,"verifyStatus":23,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":23,"url":23,"parentIds":818,"statistic":23},[],{"title":817},{"EN":38},[],{"id":41,"createTime":23,"updateTime":23,"relativeEntities":820,"slug":23,"properties":821,"entityType":23,"verifyStatus":23,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":23,"url":23,"parentIds":823,"statistic":23},[],{"title":822},{"EN":45},[],[825,832],{"id":49,"indexDatabase":826,"url":60,"indexYears":61,"academicFieldIds":831,"indexDatabaseRanking":64},{"id":51,"createTime":23,"updateTime":23,"relativeEntities":827,"label":828,"description":829,"key":57,"publicationTags":830,"standard":23},[],{"EN":54,"VI":54},{"EN":54,"VI":56},[59],[63],{"id":66,"indexDatabase":833,"url":79,"indexYears":23,"academicFieldIds":838,"indexDatabaseRanking":23},{"id":68,"createTime":23,"updateTime":23,"relativeEntities":834,"label":835,"description":836,"key":75,"publicationTags":837,"standard":23},[],{"EN":71,"VI":71},{"EN":73,"VI":74},[77,78],[81,82],{"impactFactor":85,"impactFactorByYear":840,"i10Index":85,"i10IndexLast5Year":85,"totalPublication":87,"totalPublicationByYear":841,"totalCitation":85,"totalCitationByYear":842,"totalCitationPerPublication":85,"totalCitationPerPublicationByYear":843,"hindexLast5Year":85,"hindex":85},{},{"1993":89,"2012":90,"2013":91,"2014":92,"2015":93,"2016":94,"2017":93,"2018":95,"2019":95,"2020":92,"2021":91,"2022":95,"2023":96},{},{},{"pages":845,"volume":847},{"VOID":846},"45-47",{"VOID":848},"40","2012-10-23","DONE_ANALYZE_CITATION","2026-07-30T01:48:24.762+00:00",[77,64],{"id":854,"createTime":855,"updateTime":856,"relativeEntities":857,"slug":858,"properties":859,"entityType":122,"verifyStatus":123,"verifyTime":868,"verifyNote":125,"languages":23,"translateLanguages":23,"viewCount":85,"primaryUrl":869,"fullTextUrl":23,"authors":870,"publicationType":166,"publisherRelationship":886,"citationCount":935,"citationInfo":936,"publishDate":938,"publishYear":648,"citationAnalyzeStatus":216,"lastCitationAnalyze":939,"indexDatabases":940,"openAccess":23,"references":941,"isForceReanalyzing":220},"8ebe2eb3-3027-4994-805e-49db5f19ceaf","2024-01-12T08:55:12.728+00:00","2026-07-29T10:24:37.094+00:00",[],"Practical-Recommendations-for-the-Management-of-Adenocarcinoma-of-the-Pancreas",{"abstract":860,"title":862,"gsPaper":864,"doi":866},{"EN":861},"Pancreatic cancer is widely regarded by medical personnel and the lay public as one of the most dreaded of all diagnoses. Although in selected series of operable patients the chance of long term survival may reach 20%, most patients have unfavourable disease at the time of diagnosis, and for the entire group of newly diagnosed patients, 5-year survival is rare. This grim outlook results from a combination of factors, including an anatomical location which makes early detection by screening tests or by symptoms difficult, a high tendency for spread to regional lymphatics and the liver, a poor profile of sensitivity to chemotherapeutic agents and the poor medical condition of many patients at the time of diagnosis. These factors mean that it is particularly important that at the time of diagnosis these patients are carefully evaluated, and that they and their families are fully aware of the treatment options available to them and the associated potential risks and benefits. For localised cancers, surgical resection alone offers the potential for long term survival. The addition of postoperative radiation therapy (RT) predictably improves local control but has minimal impact on survival, which is primarily determined by the development of liver metastases. Randomised trial data support the use of combined fluorouracil (5-FU) chemotherapy and RT in patients who have undergone pancreatectomy and have negative margins, although the benefits are modest and the relevant randomised trials enrolled relatively small patient numbers. For patients with marginally resectable tumours, the feasibility has been demonstrated of using chemotherapy plus RT to reduce tumour size before resection, but it is unclear whether this approach will benefit a significant number of patients. Tumours which are unresectable because of local advancement (involvement of major vessels or regional nodes) can be treated with RT alone or in combination with chemotherapy, but survival past 2 years is uncommon. Patients with liver metastases have a poor prognosis. As part of a programme of supportive care, some of these patients may receive cytotoxic therapy, the goal of which is to relieve cancer-related symptoms such as pain from the primary tumour or metastatic sites, or weakness, nausea and anorexia which may be associated with liver metastases. Although the objective response rate of chemotherapy agents is low, in an individual patient they may produce an adequate response and acceptable toxicity so that the patient experiences overall improvement in symptoms. The mainstay of chemotherapy for pancreatic cancer, as with other gastrointestinal cancers, has been fluorouracil. However, recent clinical data have shown that gemcitabine produces similar results in terms of response rate and survival, with more acceptable toxicity, so that the quality of life was judged to be better than with fluorouracil. Pancreatic cancer provides a fertile ground for testing new, biologically based approaches to cancer therapy because of the limited success of currently available treatments.",{"EN":863},"Practical Recommendations for the Management of Adenocarcinoma of the Pancreas",{"VOID":865},"[\"16520916449693505264\"]",{"VOID":867},"10.2165\u002F00003495-199957010-00006","2024-05-06T12:14:27.601+00:00","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.2165\u002F00003495-199957010-00006",[871],{"id":872,"sortIndex":85,"researcher":23,"roles":873,"affiliations":874,"properties":883,"displayName":885,"givenName":23,"familyName":23},"1d61bb88-02c8-48b0-80c3-d8a600b359e3",[244],[875],{"id":876,"sortIndex":85,"affiliation":877,"properties":23},"745191c1-7c54-46a9-91a9-f85d789e7513",{"id":876,"createTime":23,"updateTime":23,"relativeEntities":878,"slug":23,"properties":879,"entityType":23,"verifyStatus":23,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":23,"url":23,"parentIds":882,"statistic":23},[],{"title":880},{"VI":881},"Division of Hematology-Oncology, University of Connecticut Health Center, Farmington, USA",[],{"title":884},{"VI":885},"Jonathan R. Sporn",{"url":869,"publisher":887,"properties":930},{"id":6,"createTime":7,"updateTime":8,"relativeEntities":888,"slug":10,"properties":889,"entityType":21,"verifyStatus":22,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":24,"subjectFields":894,"manageAffiliations":899,"indexDatabases":910,"url":83,"thumbnailPath":23,"statistic":925,"gsStatistic":23,"type":23,"analyzePriority":23},[],{"country":890,"eissn":891,"issn":892,"title":893},{"VOID":13},{"VOID":15},{"VOID":17},{"EN":10},[895],{"id":27,"createTime":23,"updateTime":23,"relativeEntities":896,"label":897,"description":898,"parentId":23,"standard":23,"scholarHubFieldId":23},[],{"EN":30},{},[900,905],{"id":34,"createTime":23,"updateTime":23,"relativeEntities":901,"slug":23,"properties":902,"entityType":23,"verifyStatus":23,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":23,"url":23,"parentIds":904,"statistic":23},[],{"title":903},{"EN":38},[],{"id":41,"createTime":23,"updateTime":23,"relativeEntities":906,"slug":23,"properties":907,"entityType":23,"verifyStatus":23,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":23,"url":23,"parentIds":909,"statistic":23},[],{"title":908},{"EN":45},[],[911,918],{"id":49,"indexDatabase":912,"url":60,"indexYears":61,"academicFieldIds":917,"indexDatabaseRanking":64},{"id":51,"createTime":23,"updateTime":23,"relativeEntities":913,"label":914,"description":915,"key":57,"publicationTags":916,"standard":23},[],{"EN":54,"VI":54},{"EN":54,"VI":56},[59],[63],{"id":66,"indexDatabase":919,"url":79,"indexYears":23,"academicFieldIds":924,"indexDatabaseRanking":23},{"id":68,"createTime":23,"updateTime":23,"relativeEntities":920,"label":921,"description":922,"key":75,"publicationTags":923,"standard":23},[],{"EN":71,"VI":71},{"EN":73,"VI":74},[77,78],[81,82],{"impactFactor":85,"impactFactorByYear":926,"i10Index":85,"i10IndexLast5Year":85,"totalPublication":87,"totalPublicationByYear":927,"totalCitation":85,"totalCitationByYear":928,"totalCitationPerPublication":85,"totalCitationPerPublicationByYear":929,"hindexLast5Year":85,"hindex":85},{},{"1993":89,"2012":90,"2013":91,"2014":92,"2015":93,"2016":94,"2017":93,"2018":95,"2019":95,"2020":92,"2021":91,"2022":95,"2023":96},{},{},{"pages":931,"volume":933},{"VOID":932},"69-79",{"VOID":934},"57",16,{"total":935,"publishYear":648,"statisticByYear":937},{"1999":89,"2000":310,"2001":89,"2002":92,"2004":89,"2007":89,"2009":89,"2019":89},"2012-10-10","2026-07-29T10:24:37.093+00:00",[77,64],[942,948,951,954,957,960,963,966,969,972,975,978,981,984,987,990,993,996,999,1002,1005,1008,1011,1014,1017,1020,1023,1029,1032,1038,1041,1047,1053,1056,1062,1065,1068,1071,1074,1077,1080,1083,1089,1092,1098,1101,1107,1110],{"id":943,"text":944,"url":945,"identifiers":946},"4c68646b-0035-4279-8000-0006b275d4fa","Evans DB, Abbruzzese JL, Rich TA. Cancer of the pancreas. In: DeVita Jr VT, Hellman S, Rosenberg SA, editors. Cancer: principles and practice of oncology. 5th ed. Philadelphia: Lippincott-Raven, 1997","https:\u002F\u002Flink.springer.com\u002F10.1007\u002Fs10440-022-00541-7",{"doi":947},"10.1007\u002Fs10440-022-00541-7",{"id":943,"text":949,"url":945,"identifiers":950},"Metz DC. Diagnosis and treatment of pancreatic neuroendo-crine tumors. Semin Gastrointest Dis 1995; 6: 67–78",{"doi":947},{"id":943,"text":952,"url":945,"identifiers":953},"Lillemoe KD, Pitt HA. Palliation of pancreatic carcinoma. Cancer 1996; 78: 605–14",{"doi":947},{"id":943,"text":955,"url":945,"identifiers":956},"Lieberman MD, Kilburn H, Lindsey M, et al. Relation of perioperative deaths to hospital volume among patients undergoing pancreatic resection for malignancy. Ann Surg 1995; 222: 638–45",{"doi":947},{"id":943,"text":958,"url":945,"identifiers":959},"Thomas PRM. Radiotherapy for carcinoma of the pancreas. Semin Oncol 1996; 23: 213–9",{"doi":947},{"id":943,"text":961,"url":945,"identifiers":962},"Smith FP, Hoth DF, Levin B, et al. 5-Fluorouracil, adriamycin, and mitomycin-C (FAM) chemotherapy for advanced adenocarcinoma of the pancreas. Cancer 1980; 46: 2014–8",{"doi":947},{"id":943,"text":964,"url":945,"identifiers":965},"Wiggans RG, Woolley III PV, Macdonald JS, et al. Phase II trial of streptozotocin, mitomycin-C and 5-fluorouracil (SMF) in the treatment of advanced pancreatic cancer. Cancer 1978; 41: 387–91",{"doi":947},{"id":23,"text":967,"url":23,"identifiers":968},"Kaiser MH, Ellenberg SS. Pancreatic cancer: adjuvant combined radiation and chemotherapy following curative resection. Arch Surg 1985; 120: 899–903",{},{"id":943,"text":970,"url":945,"identifiers":971},"Gastrointestinal Tumor Study Group. Further evidence of effective adjuvant combined radiation and chemotherapy following curative resection of pancreatic cancer. Cancer 1987; 59: 2006–10",{"doi":947},{"id":943,"text":973,"url":945,"identifiers":974},"Whittington R, Bryer MP, Haller DG, et al. Adjuvant therapy of resected adenocarcinoma of the pancreas. Int J Rad Oncol BiolPhys 1991;21: 1137–43",{"doi":947},{"id":943,"text":976,"url":945,"identifiers":977},"Neoptolemos JP, Baker P, Beger H, et al. Progress report: a randomized multicenter European study comparing adjuvant radiotherapy, 6-mo chemotherapy, and combination therapy vs no-adjuvant treatment in resectable pancreatic cancer (ES-PAC-1). Int J Pancreatol 1997; 21: 97–104",{"doi":947},{"id":943,"text":979,"url":945,"identifiers":980},"Jessup JM, Steele Jr G, Mayer RJ, et al. Neoadjuvant therapy for unresectable pancreatic adenocarcinoma. Arch Surg 1993; 128: 559–64",{"doi":947},{"id":943,"text":982,"url":945,"identifiers":983},"Hoffman JP, Weese JL, Solin LJ, et al. A single institutional experience with preoperative chemoradiotherapy for stage I–III pancreatic adenocarcinoma. Am J Surg 1995; 169: 71–8",{"doi":947},{"id":943,"text":985,"url":945,"identifiers":986},"Hoffman JP, Lipsitz S, Pisansky T, et al. Phase II trial of preoperative radiation therapy and chemotherapy for patients with localized, resectable adenocarcinoma of the pancreas: an Eastern Cooperative Oncology Group study. J Clin Oncol 1998; 16: 317–23",{"doi":947},{"id":943,"text":988,"url":945,"identifiers":989},"Spitz FR, Abbruzzese JL, Lee JE, et al. Preoperative and postoperative chemoradiation strategies in patients treated with pancreaticoduodenectomy for adenocarcinoma of the pancreas. J Clin Oncol 1997; 15: 928–37",{"doi":947},{"id":943,"text":991,"url":945,"identifiers":992},"Staley CA, Lee JE, Cleary KR, et al. Preoperative chemoradiation, pancreaticoduodenectomy, and intraoperative radiation therapy for adenocarcinoma of the pancreatic head. Am J Surg 1996; 171: 118–25",{"doi":947},{"id":23,"text":994,"url":23,"identifiers":995},"Moertel CG, Frytak S, Hahn RG, et al. Therapy of locally unresectable pancreatic carcinoma: a randomized comparison of high dose (6000 rads) radiation alone, moderate dose radiation (4000 rads) + 5-fluorouracil, and high dose radiation + 5-fluorouracil. Cancer 1981; 48: 1705–10",{},{"id":943,"text":997,"url":945,"identifiers":998},"Whittington R, Neuberg D, Tester WJ, et al. Protracted intravenous fluorouracil infusion with radiation therapy in the management of localized pancreaticobiliary carcinoma: a phase I Eastern Cooperative Oncology Group Trial. J Clin Oncol 1995; 13: 227–32",{"doi":947},{"id":943,"text":1000,"url":945,"identifiers":1001},"Ishii H, Okada S, Tokuuye K, et al. Protracted 5-fluorouracil infusion with concurrent radiotherapy as a treatment for locally advanced pancreatic carcinoma. Cancer 1997; 79: 1516–20",{"doi":947},{"id":23,"text":1003,"url":23,"identifiers":1004},"Moertel CG, Gunderson LL, Mailliard JA, et al. Early evaluation of combined fluorouracil and leucovorin as a radiation enhancer for locally unresectable, residual, or recurrent gastrointestinal carcinoma. J Clin Oncol 1994; 12: 21–7",{},{"id":943,"text":1006,"url":945,"identifiers":1007},"Klaassen DJ, MacIntyre JM, Catton GE, et al. Treatment of locally unresectable cancer of the stomach and pancreas: a randomized comparison of 5-fluorouracil alone with radiation plus concurrent and maintenance 5-fluorouracil. An Eastern Cooperative Oncology Group study. J Clin Oncol 1985; 3: 373–8",{"doi":947},{"id":943,"text":1009,"url":945,"identifiers":1010},"Gastrointestinal Study Group. Treatment of locally unresectable carcinoma of the pancreas: comparison of combined-modality therapy (chemotherapy plus radiotherapy) to chemotherapy alone. J Natl Cancer Inst 1988; 80: 751–5",{"doi":947},{"id":943,"text":1012,"url":945,"identifiers":1013},"Schnall SF, Macdonald JS. Chemotherapy of adenocarcinoma of the pancreas. Semin Oncol 1996; 23: 220–8",{"doi":947},{"id":943,"text":1015,"url":945,"identifiers":1016},"Mallinson CN, Rake MO, Cocking JB, et al. Chemotherapy in pancreatic cancer: results of a controlled, prospective, randomised, multicentre trial. BMJ 1980; 281: 1589–91",{"doi":947},{"id":943,"text":1018,"url":945,"identifiers":1019},"Cullinan S, Moertel CG, Wieand HS, et al. A phase III trial on the therapy of advanced pancreatic cancer: evaluations of the Mallinson regimen and combined 5-fluorouracil, doxorubicin, and cisplatin. Cancer 1990; 65: 2207–12",{"doi":947},{"id":943,"text":1021,"url":945,"identifiers":1022},"Palmer KR, Kerr M, Knowles G, et al. Chemotherapy prolongs survival in inoperable pancreatic carcinoma. Br J Surg 1994; 81: 882–5",{"doi":947},{"id":1024,"text":1025,"url":1026,"identifiers":1027},"a80979db-28d1-4baa-a83a-84fa83672058","Burris III HA, Moore MJ, Andersen J, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 1997; 15: 2403–13","https:\u002F\u002Fascopubs.org\u002Fdoi\u002F10.1200\u002FJCO.1997.15.6.2403",{"doi":1028},"10.1200\u002Fjco.1997.15.6.2403",{"id":943,"text":1030,"url":945,"identifiers":1031},"Whitehead RP, Jacobson J, Brown TD, et al. Phase II trial of paclitaxel and granulocyte colony-stimulating factor in patients with pancreatic carcinoma: a Southwest Oncology Group study. J Clin Oncol 1997; 15: 2414–9",{"doi":947},{"id":1033,"text":1034,"url":1035,"identifiers":1036},"b502a8ca-f445-45ae-b16e-55d3a6ff0958","Scher RM, Kosierowski R, Lusch C, et al. Phase II trial of topotecan in advanced or metastatic adenocarcinoma of the pancreas. Invest New Drugs 1996; 13: 347–54","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1007\u002FBF00873143",{"doi":1037},"10.1007\u002FBF00873143",{"id":943,"text":1039,"url":945,"identifiers":1040},"DiBartolomeo M, Bajetta E, Somma L, et al. Doxifluridine as palliative treatment in advanced gastric and pancreatic cancer patients. Oncology 1996; 53: 54–7",{"doi":947},{"id":1042,"text":1043,"url":1044,"identifiers":1045},"d741091e-a46f-461d-bcdd-5ba287731ba7","Schwartz GK, Casper ES. A phase II trial of doxorubicin HCl liposome injection in patients with advanced pancreatic adenocarcinoma. Invest New Drugs 1995; 13: 77–82","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1007\u002FBF02614225",{"doi":1046},"10.1007\u002FBF02614225",{"id":1048,"text":1049,"url":1050,"identifiers":1051},"8d57f9fe-9f6a-4dae-98f2-076cfd3a0567","Pazdur R, Meropol NJ, Casper ES, et al. Phase II trial of ZD1694 (tomudex) in patients with advanced pancreatic cancer. Invest New Drugs 1996; 13: 355–8","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1007\u002FBF00873144",{"doi":1052},"10.1007\u002FBF00873144",{"id":943,"text":1054,"url":945,"identifiers":1055},"Friess H, Beger HG, Kunz J, et al. Treatment of advanced pancreatic cancer with mistletoe: results of a pilot trial. Anti-cancer Res 1996; 16: 915–20",{"doi":947},{"id":1057,"text":1058,"url":1059,"identifiers":1060},"1200373e-a697-4f8f-8c50-5545a043dabf","Bolli E, Saccomanno S, Mondini G, et al. 5-Fluorouracil plus 5-methyltetrahydrofolate in advanced pancreatic cancer. Cancer Chemother Pharmacol 1995; 35: 339–42","http:\u002F\u002Flink.springer.com\u002F10.1007\u002FBF00689455",{"doi":1061},"10.1007\u002FBF00689455",{"id":943,"text":1063,"url":945,"identifiers":1064},"Scheithauer W, Kornek G, Raderer M, et al. Phase MI trial of dexverapamil, epirubicin and granulocyte\u002Fmacrophage colony-stimulating factor in patients with advanced pancreatic adenocarcinoma. J Cancer Res Clin Oncol 1995; 121 Suppl. 3: R7–10",{"doi":947},{"id":943,"text":1066,"url":945,"identifiers":1067},"Kantarjian H, Ajani JA, Karlin DA. Cis-diaminodichloroplatinum chemotherapy for advanced adenocarcinoma of the upper gastrointestinal tract. Oncology 1985; 42: 69–71",{"doi":947},{"id":943,"text":1069,"url":945,"identifiers":1070},"Rigg A, Cunningham D, Gore M, et al. A phase I\u002FII study of leucovorin, carboplatin and 5-fluorouracil (LCF) in patients with carcinoma of unknown primary site or advanced oesophagogastric\u002Fpancreatic adenocarcinomas. Br J Cancer 1997; 75: 101–5",{"doi":947},{"id":943,"text":1072,"url":945,"identifiers":1073},"Sparano JA, Lipsitz S, Wadler S, et al. Phase II trial of prolonged continuous infusion of 5-fluorouracil and interferon-α in patients with advanced pancreatic cancer. Am J Clin Oncol 1996; 19: 546–51",{"doi":947},{"id":943,"text":1075,"url":945,"identifiers":1076},"Colleoni M, Nelli P, Vicario G, et al. Phase II study of oral 1-leucovorin, 120-hour fluorouracil infusion and carboplatin in advanced pancreatic cancer. Tumori 1996; 82: 573–5",{"doi":947},{"id":943,"text":1078,"url":945,"identifiers":1079},"Evans TR, Lofts FJ, Mansi JL, et al. A phase II study of continuous-infusion 5-fluorouracil with cisplatin and epirubicin in inoperable pancreatic cancer. Br J Cancer 1996; 73: 1260–4",{"doi":947},{"id":943,"text":1081,"url":945,"identifiers":1082},"Sporn JR, Buzaid AC, Slater D, et al. Treatment of advanced pancreatic adenocarcinoma with 5-FU, leucovorin, interferon-α-2b, and cisplatin. Am J Clin Oncol 1997; 20: 81–3",{"doi":947},{"id":1084,"text":1085,"url":1086,"identifiers":1087},"5eacf9e6-ae4e-4129-8d72-2fe8d09313c1","Fazeny B, Baur M, Prohaska M, et al. Octreotide combined with goserelin in the therapy of advanced pancreatic cancer: results of a pilot study and review of the literature. J Cancer Res Clin Oncol 1997; 123: 45–52","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1007\u002FBF01212614",{"doi":1088},"10.1007\u002FBF01212614",{"id":943,"text":1090,"url":945,"identifiers":1091},"Wong A, Chan A. Survival benefit of tamoxifen therapy in adenocarcinoma of pancreas: acase-control study. Cancer 1993; 71: 2200–3",{"doi":947},{"id":1093,"text":1094,"url":1095,"identifiers":1096},"fe3a331a-e2ba-4b4d-8a7b-1779e15fa6cd","Bramhall SR. The matrix metalloproteinases and their inhibitors in pancreatic cancer. Int J Pancreatol 1997; 21: 1–12","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1007\u002FBF02785914",{"doi":1097},"10.1007\u002FBF02785914",{"id":943,"text":1099,"url":945,"identifiers":1100},"Sparano JA, Fisher RI, Weiss GR, et al. Phase II trials of high-dose interleukin-2 and lymphokine-activated killer cells in advanced breast carcinoma and carcinoma of the lung, ovary, and pancreas and other tumors. 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Treatment of persistent ischaemia might call for early revascularisation. Early prevention of reocclusion with aspirin is recommended. It is advisable to correct blood lipid disturbances and to treat elevated blood pressure. β-Blocking drugs have shown worthwhile reductions of both non-fatal and fatal recurrences, whereas calcium blockers and antiarrhythmic drugs have not been found to be effective. Anticoagulants have not been definitely effective in reducing mortality but seem to have some effects on non-fatal recurrences. Platelet active drugs, among which aspirin is the best documented, reduce the incidence of both non-fatal and fatal recurrences.",{"EN":1399},"Practical Guidelines for Drug Therapy after Myocardial Infarction",{"VOID":1401},"[\"14692085590273372997\"]",{"VOID":1403},"Åberg A, Bergstrand R, Johansson S, Ulvenstam G, Vedin A, et al. Declining trend in mortality after myocardial infarction. British Heart Journal 51: 346–351, 1984\nAntiplatelet Trialists’ Collaboration. Secondary prevention of vascular disease by prolonged antiplatelet treatment. British Medical Journal 296: 320–331, 1988\nBrowner WS, Hulley SB. Clinical trials of hypertension treatment: implications for subgroups. Hypertension, in press, 1988\nCanner PL, Berge KG, Wenger NK, Stamler J, Friedman L, et al. Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. Journal of the American College of Cardiology 8: 1245–1255, 1986\nCardiac Arrhythmia Suppression Trial (CAST) Investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomised trial of arrhythmia suppression after myocardial infarction. New England Journal of Medicine 321: 406–412, 1989\nCohn JN, Archibald DG, Ziesche S, Franciosa JA, Harston WE, et al. Effect of vasodilator therapy on mortality in chronic congestive heart failure: results of a Veterans Administration Cooperative Study. New England Journal of Medicine 314: 1547–1552, 1986\nCONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure. New England Journal of Medicine 316: 1429–1435, 1987\nCoronary Drug Project Research Group. Natural history of myocardial infarction in the Coronary Drug Project: long-term prognostic importance of serum lipid levels. American Journal of Cardiology 42: 489–498, 1978\nHugenholtz PG, Hagemeijer F, Lubsen J, Glazer B, VanDurme JP, et al. One year follow-up in patients with persistent ventricular dysrhythmias after myocardial infarction treated with aprindine or placebo. In Sandoe E et al. (Eds) Management of ventricular tachycardia: role of mexiletine, pp. 572–578, Excerpta Medica, Amsterdam, 1978\nISIS-1 (First International Study of Infarct Survival) Collaborative Group. Randomised trial of intravenous atenolol among 16,027 cases of suspected acute myocardial infarction. Lancet 2: 56–66, 1986\nISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction. Lancet 2: 349–360, 1988\nMay GS, Eberlein KA, Furberg CD, Passamani ER, DeMets D. Secondary prevention after myocardial infarction: a review of long-term trials. Progress in Cardiovascular Disease 24: 331–352, 1982\nMacMahon SW, Cutler JA, Neaton JD, Furberg CF, Cohen JD, et al. Relationship of blood pressure to coronary and stroke morbidity and mortality in clinical trials and epidemiological studies. Journal of Hypertension 4 (Suppl. 6): S14–S17, 1986\nMcCall M, Elmfeldt D, Vedin A, Wilhelmsson C, Wedel H, et al. Influence of a myocardial infarction on blood pressure and serum cholesterol. Acta Medica Scandinavica 206: 477–481, 1979\nMIAMI Trial Research Group. Metoprolol in acute myocardial infarction (MIAMI): a randomized placebo-controlled trial. European Heart Journal 6: 199–226, 1985\nMulticenter Diltiazem Postinfarction Trial Research Group. The effect of diltiazem on mortality and reinfarction after myocardial infarction. New England Journal of Medicine 319: 385–392, 1988\nPfeffer MA, Lamas GA, Vaughan DE, Parisi AF, Braunwald E. Effect of captopril on progressive ventricular dilatation after anterior myocardial infarction. New England Journal of Medicine 319: 80–86, 1988\nSharpe N, Murphy J, Smith H, Hannan S. Treatment of patients with symptom less left ventricular dysfunction after myocardial infarction. Lancet 1: 255–259, 1988\nUlvenstam G, Åberg A, Bergstrand R, Johansson S, Pennert K, et al. Recurrent myocardial infarction. 1. Natural history of fatal and non-fatal events. European Heart Journal 6: 294–302, 1985\nUlvenstam G, Bergstrand R, Johansson S, Vedin A, Wilhelmsson C, et al. Prognostic importance of cholesterol levels after myocardial infarction. Preventive Medicine 13: 355–366, 1984\nYusuf S. Interventions that potentially limit myocardial infarct size: overview of clinical trials. American Journal of Cardiology 60: 11 A–17 A, 1986\nYusuf S, Peto R, Lewis J, Collins R, Sleight P. Beta-blockade during and after myocardial infarction: an overview of the randomised trials. Progress in Cardiovascular Diseases 27: 335–371, 1985\nYusuf S, Wittes J, Friedman L. Overview of results of randomised clinical trials in heart disease. 1. Treatments following myocardial infarction. Journal of the American Medical Association 260: 2088–2093, 1988",{"VOID":1405},"10.2165\u002F00003495-198938060-00010","2024-06-24T19:59:21.487+00:00","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.2165\u002F00003495-198938060-00010",[1409],{"id":1410,"sortIndex":85,"researcher":23,"roles":1411,"affiliations":1412,"properties":1421,"displayName":1423,"givenName":23,"familyName":23},"a2b45b7a-5896-4be7-8faf-0847d5c1ff67",[244],[1413],{"id":1414,"sortIndex":85,"affiliation":1415,"properties":23},"74982b3c-3301-467f-bee0-550f2500bc05",{"id":1414,"createTime":23,"updateTime":23,"relativeEntities":1416,"slug":23,"properties":1417,"entityType":23,"verifyStatus":23,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":23,"url":23,"parentIds":1420,"statistic":23},[],{"title":1418},{"VI":1419},"Department of Medicine, Östra Hospital, Gothenburg, Sweden",[],{"title":1422},{"VI":1423},"Lars Wilhelmsen",{"url":1407,"publisher":1425,"properties":1468},{"id":6,"createTime":7,"updateTime":8,"relativeEntities":1426,"slug":10,"properties":1427,"entityType":21,"verifyStatus":22,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":24,"subjectFields":1432,"manageAffiliations":1437,"indexDatabases":1448,"url":83,"thumbnailPath":23,"statistic":1463,"gsStatistic":23,"type":23,"analyzePriority":23},[],{"country":1428,"eissn":1429,"issn":1430,"title":1431},{"VOID":13},{"VOID":15},{"VOID":17},{"EN":10},[1433],{"id":27,"createTime":23,"updateTime":23,"relativeEntities":1434,"label":1435,"description":1436,"parentId":23,"standard":23,"scholarHubFieldId":23},[],{"EN":30},{},[1438,1443],{"id":34,"createTime":23,"updateTime":23,"relativeEntities":1439,"slug":23,"properties":1440,"entityType":23,"verifyStatus":23,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":23,"url":23,"parentIds":1442,"statistic":23},[],{"title":1441},{"EN":38},[],{"id":41,"createTime":23,"updateTime":23,"relativeEntities":1444,"slug":23,"properties":1445,"entityType":23,"verifyStatus":23,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":23,"url":23,"parentIds":1447,"statistic":23},[],{"title":1446},{"EN":45},[],[1449,1456],{"id":49,"indexDatabase":1450,"url":60,"indexYears":61,"academicFieldIds":1455,"indexDatabaseRanking":64},{"id":51,"createTime":23,"updateTime":23,"relativeEntities":1451,"label":1452,"description":1453,"key":57,"publicationTags":1454,"standard":23},[],{"EN":54,"VI":54},{"EN":54,"VI":56},[59],[63],{"id":66,"indexDatabase":1457,"url":79,"indexYears":23,"academicFieldIds":1462,"indexDatabaseRanking":23},{"id":68,"createTime":23,"updateTime":23,"relativeEntities":1458,"label":1459,"description":1460,"key":75,"publicationTags":1461,"standard":23},[],{"EN":71,"VI":71},{"EN":73,"VI":74},[77,78],[81,82],{"impactFactor":85,"impactFactorByYear":1464,"i10Index":85,"i10IndexLast5Year":85,"totalPublication":87,"totalPublicationByYear":1465,"totalCitation":85,"totalCitationByYear":1466,"totalCitationPerPublication":85,"totalCitationPerPublicationByYear":1467,"hindexLast5Year":85,"hindex":85},{},{"1993":89,"2012":90,"2013":91,"2014":92,"2015":93,"2016":94,"2017":93,"2018":95,"2019":95,"2020":92,"2021":91,"2022":95,"2023":96},{},{},{"pages":1469,"volume":1471},{"VOID":1470},"1000-1007",{"VOID":1472},"38",{"total":93,"publishYear":648,"statisticByYear":1474},{"1991":89,"1995":89,"1997":296,"2002":89,"2004":89},"2026-07-27T02:40:30.590+00:00",[77,64],{"id":1478,"createTime":1479,"updateTime":1480,"relativeEntities":1481,"slug":1482,"properties":1483,"entityType":122,"verifyStatus":123,"verifyTime":1492,"verifyNote":125,"languages":23,"translateLanguages":23,"viewCount":85,"primaryUrl":1493,"fullTextUrl":23,"authors":1494,"publicationType":166,"publisherRelationship":1510,"citationCount":1558,"citationInfo":1559,"publishDate":1563,"publishYear":548,"citationAnalyzeStatus":850,"lastCitationAnalyze":1564,"indexDatabases":1565,"openAccess":23,"references":1566,"isForceReanalyzing":220},"5bd182aa-f5dd-46ef-8039-75cb3ee55c97","2024-01-05T16:36:45.660+00:00","2026-07-27T01:23:08.115+00:00",[],"Esaxerenone-First-Global-Approval",{"abstract":1484,"title":1486,"gsPaper":1488,"doi":1490},{"EN":1485},"Esaxerenone (MINNEBRO™)—a novel oral, non-steroidal, selective mineralocorticoid receptor blocker—is being developed by Daiichi Sankyo for the treatment of hypertension and diabetic nephropathies. In January 2019, based on positive results from a phase III trial conducted in Japan in patients with essential hypertension, esaxerenone received marketing approval in Japan for the treatment of hypertension. This article summarizes the milestones in the development of esaxerenone leading to this first global approval for the treatment of hypertension.",{"EN":1487},"Esaxerenone: First Global Approval",{"VOID":1489},"[\"7066843540499543331\"]",{"VOID":1491},"10.1007\u002Fs40265-019-01073-5","2024-05-02T05:54:00.388+00:00","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1007\u002Fs40265-019-01073-5",[1495],{"id":1496,"sortIndex":85,"researcher":23,"roles":1497,"affiliations":1498,"properties":1507,"displayName":1509,"givenName":23,"familyName":23},"66e84edd-25d5-4267-a5d0-426bc41da02b",[244],[1499],{"id":1500,"sortIndex":85,"affiliation":1501,"properties":23},"713ccd30-5d01-4be1-a79d-8ef706effcb6",{"id":1500,"createTime":23,"updateTime":23,"relativeEntities":1502,"slug":23,"properties":1503,"entityType":23,"verifyStatus":23,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":23,"url":23,"parentIds":1506,"statistic":23},[],{"title":1504},{"VI":1505},"Springer, Auckland, New Zealand",[],{"title":1508},{"VI":1509},"Sean Duggan",{"url":1493,"publisher":1511,"properties":1554},{"id":6,"createTime":7,"updateTime":8,"relativeEntities":1512,"slug":10,"properties":1513,"entityType":21,"verifyStatus":22,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":24,"subjectFields":1518,"manageAffiliations":1523,"indexDatabases":1534,"url":83,"thumbnailPath":23,"statistic":1549,"gsStatistic":23,"type":23,"analyzePriority":23},[],{"country":1514,"eissn":1515,"issn":1516,"title":1517},{"VOID":13},{"VOID":15},{"VOID":17},{"EN":10},[1519],{"id":27,"createTime":23,"updateTime":23,"relativeEntities":1520,"label":1521,"description":1522,"parentId":23,"standard":23,"scholarHubFieldId":23},[],{"EN":30},{},[1524,1529],{"id":34,"createTime":23,"updateTime":23,"relativeEntities":1525,"slug":23,"properties":1526,"entityType":23,"verifyStatus":23,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":23,"url":23,"parentIds":1528,"statistic":23},[],{"title":1527},{"EN":38},[],{"id":41,"createTime":23,"updateTime":23,"relativeEntities":1530,"slug":23,"properties":1531,"entityType":23,"verifyStatus":23,"verifyTime":23,"verifyNote":23,"languages":23,"translateLanguages":23,"viewCount":23,"url":23,"parentIds":1533,"statistic":23},[],{"title":1532},{"EN":45},[],[1535,1542],{"id":49,"indexDatabase":1536,"url":60,"indexYears":61,"academicFieldIds":1541,"indexDatabaseRanking":64},{"id":51,"createTime":23,"updateTime":23,"relativeEntities":1537,"label":1538,"description":1539,"key":57,"publicationTags":1540,"standard":23},[],{"EN":54,"VI":54},{"EN":54,"VI":56},[59],[63],{"id":66,"indexDatabase":1543,"url":79,"indexYears":23,"academicFieldIds":1548,"indexDatabaseRanking":23},{"id":68,"createTime":23,"updateTime":23,"relativeEntities":1544,"label":1545,"description":1546,"key":75,"publicationTags":1547,"standard":23},[],{"EN":71,"VI":71},{"EN":73,"VI":74},[77,78],[81,82],{"impactFactor":85,"impactFactorByYear":1550,"i10Index":85,"i10IndexLast5Year":85,"totalPublication":87,"totalPublicationByYear":1551,"totalCitation":85,"totalCitationByYear":1552,"totalCitationPerPublication":85,"totalCitationPerPublicationByYear":1553,"hindexLast5Year":85,"hindex":85},{},{"1993":89,"2012":90,"2013":91,"2014":92,"2015":93,"2016":94,"2017":93,"2018":95,"2019":95,"2020":92,"2021":91,"2022":95,"2023":96},{},{},{"pages":1555,"volume":1557},{"VOID":1556},"477-481",{"VOID":546},84,{"total":1558,"publishYear":548,"statisticByYear":1560},{"2019":89,"2020":95,"2021":211,"2022":1561,"2023":1562,"2024":211,"2025":91,"2026":310},25,15,"2019-02-26","2026-07-27T01:23:08.114+00:00",[77,64],[1567,1570,1573,1576,1580,1584,1587,1591,1594,1597,1600,1603,1606],{"id":943,"text":1568,"url":945,"identifiers":1569},"Mulatero P, Milan A, Williams TA, et al. Mineralocorticoid receptor blockade in the protection of target organ damage. Cardiovasc Hematol Agents Med Chem. 2006;4(1):75–91.",{"doi":947},{"id":943,"text":1571,"url":945,"identifiers":1572},"Kato M, Furuie H, Shimizu T, et al. Single- and multiple-dose escalation study to assess pharmacokinetics, pharmacodynamics and safety of oral esaxerenone in healthy Japanese subjects. Br J Clin Pharmacol. 2018;84(8):1821–9.",{"doi":947},{"id":943,"text":1574,"url":945,"identifiers":1575},"Shibata S, Ishizawa K, Uchida S. Mineralocorticoid receptor as a therapeutic target in chronic kidney disease and hypertension. Hypertens Res. 2017;40(3):221–5.",{"doi":947},{"id":23,"text":1577,"url":1578,"identifiers":1579},"Daiichi Sankyo. Esaxerenone (Minnebro): Japanese prescribing information; 2019. http:\u002F\u002Fwww.pmda.go.jp\u002FPmdaSearch\u002FiyakuDetail\u002F430574_21490B6F1026_1_02#CONTRAINDICATIONS. Accessed 15 Jan 2019.","http:\u002F\u002Fwww.pmda.go.jp\u002FPmdaSearch\u002FiyakuDetail\u002F430574_21490B6F1026_1_02#CONTRAINDICATIONS",{},{"id":23,"text":1581,"url":1582,"identifiers":1583},"Daiichi Sankyo. Daiichi Sankyo announces approval of MINNEBRO™ tablets for the treatment of hypertension in Japan [media release]. 8 Jan 2019. https:\u002F\u002Fwww.daiichisankyo.com.","https:\u002F\u002Fwww.daiichisankyo.com",{},{"id":23,"text":1585,"url":23,"identifiers":1586},"Ito S, Ito H, Rakugi H, et al. A double blind phase III study of esaxerenone (CS-3150) compared to eplerenone in patients with essential hypertension (ESAX-HTN study). J Hypertens. 2018;36(Suppl 1):e239.",{},{"id":23,"text":1588,"url":1589,"identifiers":1590},"Daiichi Sankyo. Sankyo and Exelixis sign joint research agreement [media release]. 23 Mar 2016. https:\u002F\u002Fwww.sec.gov\u002FArchives\u002Fedgar\u002Fdata\u002F1340156\u002F000119312506061375\u002Fdex991.htm.","https:\u002F\u002Fwww.sec.gov\u002FArchives\u002Fedgar\u002Fdata\u002F1340156\u002F000119312506061375\u002Fdex991.htm",{},{"id":943,"text":1592,"url":945,"identifiers":1593},"Exelixis. Exelixis announces first quarter 2006 financial results [media release]. 9 May 2006. http:\u002F\u002Fwww.exelixis.com.",{"doi":947},{"id":943,"text":1595,"url":945,"identifiers":1596},"Arai K, Homma T, Morikawa Y, et al. Pharmacological profile of CS-3150, a novel, highly potent and selective non-steroidal mineralocorticoid receptor antagonist. Eur J Pharmacol. 2015;761:226–34.",{"doi":947},{"id":943,"text":1598,"url":945,"identifiers":1599},"Arai K, Morikawa Y, Ubukata N, et al. CS-3150, a novel nonsteroidal mineralocorticoid receptor antagonist, shows preventive and therapeutic effects on renal injury in deoxycorticosterone acetate\u002Fsalt-induced hypertensive rats. J Pharmacol Exp Ther. 2016;358(3):548–57.",{"doi":947},{"id":943,"text":1601,"url":945,"identifiers":1602},"Arai K, Tsuruoka H, Homma T. CS-3150, a novel non-steroidal mineralocorticoid receptor antagonist, prevents hypertension and cardiorenal injury in Dahl salt-sensitive hypertensive rats. Eur J Pharmacol. 2015;769:266–73.",{"doi":947},{"id":943,"text":1604,"url":945,"identifiers":1605},"Yamada M, Mendell J, Takakusa H, et al. Pharmacokinetics, metabolism, and excretion of [14C]esaxerenone, a novel mineralocorticoid receptor blocker in humans. Drug Metab Dispos. 2019;47(3):340–9.",{"doi":947},{"id":23,"text":1607,"url":23,"identifiers":1608},"Ito S, Ito H, Rakugi H, et al. Treatment with esaxerenone (CS-3150) is associated with a significant dose dependent antihypertensive effect in essential hypertensive patients [abstract no. BP.02.01]. J Hypertens. 2017;35(Suppl 2):e173.",{}]