Effect of open-label infusion of an apoA-I-containing particle (CER-001) on RCT and artery wall thickness in patients with FHA

Fruchart, 2014, Residual macrovascular risk in 2013: what have we learned?, Cardiovasc. Diabetol., 13, 26, 10.1186/1475-2840-13-26 Di Angelantonio, 2009, Emerging Risk Factors Collaboration, Major lipids, apolipoproteins, and risk of vascular disease.JAMA., 302, 1993 Kannel, 1979, Cholesterol in the prediction of atherosclerotic disease. New perspectives based on the Framingham study, Ann. Intern. Med., 90, 85, 10.7326/0003-4819-90-1-85 Schwartz, 2012, Effects of dalcetrapib in patients with a recent acute coronary syndrome, N. Engl. J. Med., 367, 2089, 10.1056/NEJMoa1206797 Boden, 2011, Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy, N. Engl. J. Med., 365, 2255, 10.1056/NEJMoa1107579 Voight, 2012, Plasma HDL cholesterol and risk of myocardial infarction: A mendelian randomisation study, Lancet., 380, 572, 10.1016/S0140-6736(12)60312-2 Zhang, 2003, Overexpression of apolipoprotein A-I promotes reverse transport of cholesterol from macrophages to feces in vivo, Circulation., 108, 661, 10.1161/01.CIR.0000086981.09834.E0 Duverger, 1996, Inhibition of atherosclerosis development in cholesterol-fed human apolipoprotein A-I-transgenic rabbits, Circulation., 94, 713, 10.1161/01.CIR.94.4.713 Holleboom, 2013, In vivo tissue cholesterol efflux is reduced in carriers of a mutation in APOA1, J. Lipid Res., 54, 1964, 10.1194/jlr.P028449 Bochem, 2013, ABCA1 mutation carriers with low high-density lipoprotein cholesterol are characterized by a larger atherosclerotic burden, Eur. Heart J., 34, 286, 10.1093/eurheartj/ehs376 Duivenvoorden, 2011, Carriers of lecithin cholesterol acyltransferase gene mutations have accelerated atherogenesis as assessed by carotid 3.0-T magnetic resonance imaging, J. Am. Coll. Cardiol., 58, 2481, 10.1016/j.jacc.2010.11.092 Eriksson, 1999, Stimulation of fecal steroid excretion after infusion of recombinant proapolipoprotein A-I: potential reverse cholesterol transport in humans, Circulation., 100, 594, 10.1161/01.CIR.100.6.594 Nanjee, 2001, Intravenous apoA-I/lecithin discs increase pre-beta-HDL concentration in tissue fluid and stimulate reverse cholesterol transport in humans, J. Lipid Res., 42, 1586, 10.1016/S0022-2275(20)32212-4 Shaw, 2008, Infusion of reconstituted high-density lipoprotein leads to acute changes in human atherosclerotic plaque, Circ. Res., 103, 1084, 10.1161/CIRCRESAHA.108.182063 Nissen, 2003, Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial, JAMA., 290, 2292, 10.1001/jama.290.17.2292 Tardif, 2007, Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial, JAMA., 297, 1675, 10.1001/jama.297.15.jpc70004 Tardif, 2014, Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial, Eur. Heart J., 35, 3277, 10.1093/eurheartj/ehu171 a., Goffinet, M., Baron, R., Tardy, C., Sy, G., Schwendeman, A., Keyserling, C. H., Wetterau, J., Barbaras, R., Lalwani, N., Dasseux, J-L., . 2011. CER-001, a new generation of HDL mimetic: characterization and determination of in vitro and in vivo activities; ATVB Scientific Sessions. P364. de la Llera-Moya, 2010, The ability to promote efflux via ABCA1 determines the capacity of serum specimens with similar high-density lipoprotein cholesterol to remove cholesterol from macrophages, Arterioscler. Thromb. Vasc. Biol., 30, 796, 10.1161/ATVBAHA.109.199158 Heinemann, 1991, Mechanisms of action of plant sterols on inhibition of cholesterol absorption, Eur. J. Clin. Pharmacol., 40, S59, 10.1007/BF01409411 Arca, 1983, An improved gas-liquid chromatographic method for the determination of fecal neutral sterols, J. Lipid Res., 24, 332, 10.1016/S0022-2275(20)38002-0 Setchell, 1983, General methods for the analysis of metabolic profiles of bile acids and related compounds in feces, J. Lipid Res., 24, 1085, 10.1016/S0022-2275(20)37923-2 Duivenvoorden, 2009, In vivo quantification of carotid artery wall dimensions: 3.0-Tesla MRI versus B-mode ultrasound imaging, Circ. Cardiovasc. Imaging., 2, 235, 10.1161/CIRCIMAGING.108.788059 Tawakol, 2006, In vivo 18F-fluorodeoxyglucose positron emission tomography imaging provides a noninvasive measure of carotid plaque inflammation in patients, J. Am. Coll. Cardiol., 48, 1818, 10.1016/j.jacc.2006.05.076 Rudd, 2007, (18)Fluorodeoxyglucose positron emission tomography imaging of atherosclerotic plaque inflammation is highly reproducible: implications for atherosclerosis therapy trials, J. Am. Coll. Cardiol., 50, 892, 10.1016/j.jacc.2007.05.024 Fayad, 2011, Safety and efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging (dal-PLAQUE): a randomised clinical trial, Lancet., 378, 1547, 10.1016/S0140-6736(11)61383-4 Björnsson, 2006, Drug-induced liver injury: Hy's rule revisited, Clin. Pharmacol. Ther., 79, 521, 10.1016/j.clpt.2006.02.012 Jonas, 2000, Lecithin cholesterol acyltransferase, Biochim. Biophys. Acta., 1529, 245, 10.1016/S1388-1981(00)00153-0 Kontush, 2004, Antioxidative activity of HDL particle subspecies is impaired in hyperalphalipoproteinemia: relevance of enzymatic and physicochemical properties, Arterioscler. Thromb. Vasc. Biol., 24, 526, 10.1161/01.ATV.0000118276.87061.00 Wang, 2011, CETP expression reverses the reconstituted HDL-induced increase in VLDL, J. Lipid Res., 52, 1533, 10.1194/jlr.M016659 Tardy, C., Goffinet, M., Boubekeur, N., Ackermann, R., Sy, G., Bluteau, A., Cholez, G., Keyserling, C., Lalwani, N., Paolini, J. F., . CER-001, an HDL-mimetic, stimulates the reverse lipid transport and atherosclerosis regression in high cholesterol diet-fed LDL-receptor deficient mice. Atherosclerosis., 232: 110-118. Shah, 2001, High-dose recombinant apolipoprotein A-I(Milano) mobilizes tissue cholesterol and rapidly reduces plaque lipid and macrophage content in apolipoprotein e-deficient mice. Potential implications for acute plaque stabilization, Circulation., 103, 3047, 10.1161/hc2501.092494 Jiao, 1990, Genetic heterogeneity of lipoproteins in inbred strains of mice: analysis by gel-permeation chromatography, Metabolism., 39, 155, 10.1016/0026-0495(90)90069-O Diditchenko, 2013, Novel formulation of a reconstituted high-density lipoprotein (CSL112) dramatically enhances ABCA1-dependent cholesterol efflux, Arterioscler. Thromb. Vasc. Biol., 33, 2202, 10.1161/ATVBAHA.113.301981 Khera, 2011, Cholesterol efflux capacity, high-density lipoprotein function, and atherosclerosis, N. Engl. J. Med., 364, 127, 10.1056/NEJMoa1001689 Wang, 2007, Macrophage ABCA1 and ABCG1, but not SR-BI, promote macrophage reverse cholesterol transport in vivo, J. Clin. Invest., 117, 2216, 10.1172/JCI32057 Rohatgi, 2014, HDL cholesterol efflux capacity and incident cardiovascular events, N. Engl. J. Med., 371, 2383, 10.1056/NEJMoa1409065 Rosenson, 2012, Cholesterol efflux and atheroprotection: advancing the concept of reverse cholesterol transport, Circulation., 125, 1905, 10.1161/CIRCULATIONAHA.111.066589 Nicholls, 2005, Impact of short-term administration of high-density lipoproteins and atorvastatin on atherosclerosis in rabbits, Arterioscler. Thromb. Vasc. Biol., 25, 2416, 10.1161/01.ATV.0000184760.95957.d6 Waksman, 2010, A first-in-man, randomized, placebo-controlled study to evaluate the safety and feasibility of autologous delipidated high-density lipoprotein plasma infusions in patients with acute coronary syndrome, J. Am. Coll. Cardiol., 55, 2727, 10.1016/j.jacc.2009.12.067 Rye, 2014, Cardioprotective functions of HDLs, J. Lipid Res., 55, 168, 10.1194/jlr.R039297 Westerterp, 2014, ATP-binding cassette transporters, atherosclerosis, and inflammation, Circ. Res., 114, 157, 10.1161/CIRCRESAHA.114.300738 Feig, 2011, Reversal of hyperlipidemia with a genetic switch favorably affects the content and inflammatory state of macrophages in atherosclerotic plaques, Circulation., 123, 989, 10.1161/CIRCULATIONAHA.110.984146 van Wijk, 2014, Nonpharmacological lipoprotein apheresis reduces arterial inflammation in familial hypercholesterolemia, J. Am. Coll. Cardiol., 64, 1418, 10.1016/j.jacc.2014.01.088 Navab, 2012, High-density lipoprotein and 4F peptide reduce systemic inflammation by modulating intestinal oxidized lipid metabolism: novel hypotheses and review of literature, Arterioscler. Thromb. Vasc. Biol., 32, 2553, 10.1161/ATVBAHA.112.300282 Haase, 2012, Population-based resequencing of APOA1 in 10,330 individuals: spectrum of genetic variation, phenotype, and comparison with extreme phenotype approach, PLoS Genet., 8, e1003063, 10.1371/journal.pgen.1003063 Haase, 2012, LCAT, HDL cholesterol and ischemic cardiovascular disease: a Mendelian randomization study of HDL cholesterol in 54,500 individuals, J. Clin. Endocrinol. Metab., 97, E248, 10.1210/jc.2011-1846 Frikke-Schmidt, 2008, Association of loss-of-function mutations in the ABCA1 gene with high-density lipoprotein cholesterol levels and risk of ischemic heart disease, JAMA., 299, 2524, 10.1001/jama.299.21.2524 Davidson, 2013, Inhibition of intestinal cholesterol absorption with ezetimibe increases components of reverse cholesterol transport in humans, Atherosclerosis., 230, 322, 10.1016/j.atherosclerosis.2013.08.006