Thiazolidinedione drugs in the treatment of type 2 diabetes mellitus: past, present and future
Tóm tắt
Từ khóa
Tài liệu tham khảo
[AFSSAPS] Agence française de sécurité sanitaire des produits de santé. Use of medications containing pioglitazone (Actos®, Competact®) Suspended. 2011. [accessed 24 Feb 2012]. www.afssaps.fr/content/download/34175/447382/version/1/file/Press-release-Suspension-Pioglitazone.pdf.
American Heart Association.Cardiovascular disease & diabetes. 2012. [accessed 2014 Dec 28]. http://www.heart.org/HEARTORG/Conditions/Diabetes/WhyDiabetesMatters/Cardiovascular-Disease-Diabetes_UCM_313865_Article.jsp#.
Associated Press. 2010. Keep Avandia on market: FDA panel. CBC News. July 14. [accessed 2010 Jul 20]. http://www.cbc.ca/health/story/2010/07/14/avandia-heart-fda.html.
Bazelier MT, 2013, Front Endocrinol (Lausanne), 4, 11
Benvenuti S, 2012, J Endocrinol Invest, 35, 365
Blanquicett C, 2008, Cancer Ther, 6, 25
Broulík PD, 2011, Folia Biol (Praha), 57, 133
Carta AR, 2011, Parkinsons Dis, 2011, 689181
Centers for Disease Control and Prevention, 2014, National diabetes statistics report: estimates of diabetes and its burden in the United States, 2014
Chao T-K, 2016, Neurotoxicology, 0161, 30016
Desai A, 2007, Gibaldi's drug delivery systems in pharmaceutical care
Diamond GA, 2007, N Engl J Med, 357, 938
Ehrmann DA, 1997, J Clin Endocrinol Metab, 82, 2108
El Hage J, Orloff D. 2005. Rodent carcinogenicity findings associated with PPAR agonists and their regulatory recommendations. Paper presented at: 3rd International Symposium on PPARS Efficacy and Safety; Monte Carlo, Monaco.
El Hage. 2005. Toxicity profiles of peroxisome proliferator-activated receptor (PPAR) agonists and preclinical safety profile for muraglitazar. US FDA Endocrinologic and Metabolic Drugs Advisory Committee. [accessed 2014 Jul 26]. http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4169S2_02_02-FDA-ElHage.ppt.
[EMA] European Medicines Agency. 2011a. European Medicines Agency recommends new contraindications and warnings for pioglitazone to reduce small increased risk of bladder cancer. [accessed 2011 Dec 12]. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/07/WC500109176.pdf.
[EMA] European Medicines Agency. 2011b. Assessment report for Actos, Glustin, Competact, Glubrava, Tandemact. [accessed 2011 Dec 12]. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000285/WC500126656.pdf.
Erdmann E, 2007, Vasc Health Risk Manag, 3, 355
Forbes. 2013. The hidden agenda behind the FDA's new Avandia hearings. [accessed 2013 May 30]. http://www.forbes.com/sites/matthewherper/2013/05/23/steven-nissen-the-hidden-agenda-behind-the-fdas-avandia-hearings/.
Gimble JM, 1996, Mol Pharmacol, 50, 1087
Giustina A, 2000, J Clin Endocrinol Metab, 85, 526
Gorter KJ, 2012, BMJ Clin Evid, 2012, 0609
Gradišer M, 2007, Croat Med J, 48, 87
Graham DJ, Green L. 1999. The epidemiology of troglitazone hepatotoxicity. FDA Metabolic-Endocrine Drugs Advisory Committee Meeting; March 26; Bethesda, Maryland. [accessed 2014 Aug 2]. http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3499t1a.pdf.
[GSK] Glaxo Smith Kline. 2012.PrAvandia®rosiglitazone (as rosiglitazone maleate). Product Monograph. [accessed 2016 Sep 20]. http://ca.gsk.com/media/522034/avandia.pdf.
[GSK] Glaxo Smith Kline. Clinical trial observation of an increased incidence of fractures in female patients who received long-term treatment with Avandia®(rosiglitazone maleate) tablets for type 2 diabetes mellitus. Dear Healthcare Provider Letter. 2007b. [accessed 2015 Mar 25]. http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM153903.pdf.
[GSK] Glaxo Smith Kline. Study no. ZM2005/00181/01: Avandia cardiovascular event modeling project. 2007a. [accessed 2015 Aug 30]. http://www.gsk-clinicalstudyregister.com/study/ZM2005/00181/01?study_ids=ZM2005/00181/01#rs.
Hampton T., 2007, JAMA, 297, 1645
Hisatake JI, 2000, Cancer Res, 60, 5494
[IARC] International Agency for Research on Cancer and [WHO] World Health Organization. 2012. GLOBOCAN 2012: estimated cancer incidence, mortality and prevalence worldwide in 2012. [accessed 2015 Sep 23]. http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.
Indiana University. 2016. Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease (PIOPKD). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). https://www.clinicaltrials.gov/ct2/show/study/NCT02697617. Identifier: NCT02697617.
International Diabetes Federation. 2014. About diabetes. Risk factors. [accessed 2014 Dec 27]. http://www.idf.org/about-diabetes/risk-factors.
Jenner RK. 2000. Rezulin: fast track to failure. Trial. American Association for Justice. [accessed 2014 Jul 31]. http://www.highbeam.com/doc/1G1-63795755.html.
Jones JI, 1995, Endocr Rev, 16, 3
Jones SG, 2009, Am J Manag Care, 15, 491
Kirk JK, 1999, J Fam Pract, 48, 879
Krieter PA, 1994, Drug Metab Dispos, 22, 625
LaSalle JR, 2006, Am J Manag Care, 12, S369
Lubet RA, 2004, Proc Am Assoc Cancer Res, 45, 725
Lumpkin MM. 2000. Troglitazone: presentation to the Endocrinologic and Metabolic Drugs Advisory Committee; May 19. Bethesda (MD): US Food and Drug Administration. http://www.fda.gov/ohrms/dockets/ac/00/slides/3615s1a/sld001.htm.
Mannucci E, 2007, N Engl J Med, 357, 938
Martino R, 2016, Neurotoxicology, 0161, 30049-3
McIntosh B, 2012, Open Med, 6, e62
McKay KA, 2016, Neurotoxicology, 0161, 30042-0
Meema H, 1967, Can Med Assoc J, 96, 132
Misbin RI. 1998. Review of liver toxicity of troglitazone. Meeting of the Food and Drug Administration Cardiorenal Advisory Committee; January 21. Bethesda (MD): US Food and Drug Administration.
Nafrialdi, 2012, Acta Acta Med Indones, 44, 28
New York Times. 2013. F.D.A. Lifts Some Restrictions on Avandia. [accessed 2013 Nov 25]. http://www.nytimes.com/2013/11/26/business/fda-lifts-some-restrictions-on-avandia.html?_r=0.
Nissen SE, 2007, N Engl J Med, 357, 939
Oz S, 2006, J Natl Med Assoc, 98, 1598
Prigeon RL, 1998, J Clin Endocrinol Metab, 83, 819
Reaven GM., 2005, Panminerva Med, 47, 201
Saul S. 2007. Heart attack risk seen in drug for diabetes. New York Times. May 22. [accessed 2010 Dec 3]. Available from:http://www.nytimes.com/2007/05/22/business/22drug.html.
Scheen AJ., 2001, Diabetes Metab, 27, 305
Schulte PA, 1987, Occup Med, 2, 85
Shaya FT, 2009, P T, 34, 490
Stolberg SG. 1999. Stricter rules are urged on use of a diabetic drug. New York Times. Mar 27. Sect. A:9.
Takeda Pharmaceuticals North America Inc. 2007. Observation of an increased incidence of fractures in female patients who received long-term treatment with ACTOS®(pioglitazone HCl) tablets for type 2 diabetes mellitus. Letter to healthcare providers. Deerfield (IL).
Takeda Pharmaceuticals U.S.A. Inc. 2009. Actos (Pioglitazone Hydrochloride) Tablets: Full Prescribing Information. [accessed 2010 Aug 26]. http://www.actos.com/actospro/home.aspx.
Tsirella E, 2012, J Physiol Pharmacol, 63, 201
Turner HE., 2001, Handbook of acromegaly
Unnikrishnan R, 2012, J Assoc Physicians India, 60, 66
[US FDA] United States Food and Drug Administration. 1997. Patient testing and labeling strengthened for Rezulin. FDA Talk Paper: T97-61. Rockville (MD): US Food and Drug Administration.
[US FDA] United States Food and Drug Administration. 1999. Actos label information. [accessed 2014 Jul 23]. http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21073lbl.pdf.
[US FDA] United States Food and Drug Administration. 2005. Muraglitazar Briefing Document, Safety Endocrine and Metabolic Drugs Advisory Committee Meeting; September 9. [accessed 2016 Sep 21]. http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4169b2_02_03-fda-medoff-safety.pdf.
[US FDA] United States Food and Drug Administration. 2010a. FDA significantly restricts access to the diabetes drug Avandia. FDA News Release. [accessed 2010 Sep 23]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm226975.htm.
[US FDA] United States Food and Drug Administration. 2010b. FDA drug safety communication: ongoing safety review of actos (pioglitazone) and potential increased risk of bladder cancer after two years exposure. September. [accessed 2010 Oct 3]. http://www.fda.gov/Drugs/DrugSafety/ucm226214.htm.
[US FDA] United States Food and Drug Administration. 2011a. FDA drug safety communication: updated risk evaluation and mitigation strategy (REMS) to restrict access to rosiglitazone-containing medicines including Avandia, Avandamet, and Avandaryl. [accessed 2011 Dec 21]. http://www.fda.gov/Drugs/DrugSafety/ucm255005.htm.
[US FDA] United States Food and Drug Administration. 2011b. Drug safety communication: update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer. [accessed 2011 Sep 3]. http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm.
[US FDA] United States Food and Drug Administration. 2013a. Summary minutes of the joint meeting of the endocrinologic and metabolic drugs advisory committee and the drug safety and risk management advisory committee; June 5–6. [accessed 2013 Nov 25]. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM369180.pdf.
[US FDA] United States Food and Drug Administration. 2013b. FDA requires removal of certain restrictions on the diabetes drug Avandia. FDA News Release. [accessed 2013 Nov 25]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376516.htm.
[US FDA] United States Food and Drug Administration. 2013c. FFDA approves three new drug treatments for type 2 diabetes. FDA News Release. [accessed 2016 Sep 21]. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm336942.htm.
[US FDA] United States Food and Drug Administration. 2016. FDA drug safety communication: updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer. [accessed 2017 Jan 28]. http://www.fda.gov/Drugs/DrugSafety/ucm519616.htm.
Wass JA, 2002, Oxford textbook of endocrinology, 1
Watson GS, 2005, Am J Geriatr Psychiatry, 13, 950
Young PW, 1998, J Pharmacol Exp Ther, 284, 751