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POOLED SAFETY AND ADVERSE EVENTS IN NINE RANDOMIZED, PLACEBO-CONTROLLED, PHASE 2 AND 3 CLINICAL TRIALS OF ALIROCUMAB
Abstract   Open access   Peer reviewed

POOLED SAFETY AND ADVERSE EVENTS IN NINE RANDOMIZED, PLACEBO-CONTROLLED, PHASE 2 AND 3 CLINICAL TRIALS OF ALIROCUMAB

Peter Jones, Harold Bays, Umesh Chaudhari, Robert Pordy, Christelle Lorenzato, Kathryn Miller and Jennifer Robinson
Journal of the American College of Cardiology, Vol.65(10), pp.A1363-A1363
03/17/2015
DOI: 10.1016/S0735-1097(15)61363-8
url
https://doi.org/10.1016/s0735-1097(15)61363-8View
Published (Version of record) Open Access

Abstract

Placebo-controlled pool of Phase 3 Adjudicated cardiovascular events, % (n) N=2318 N=1174 Any patients with TEAE adjudicated CV event (CHD death, non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization, congestive heart failure requiring hospitalization, ischemia-driven coronary revascularization procedure) 3.6 (83) 3.5 (41) Any patients with TEAE adjudicated MACE event (CHD death, non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) 1.5 (35) 2.3 (27) Other clinical laboratory data, Week 52 change from baseline N=2318 N=1174 Fasting glucose, mmol/L, mean (SD) 0.16 (1.52) 0.13 (1.64) Hemoglobin A1c, %, mean (SD) 0.10 (0.66) 0.07 (0.54) Creatine kinase, ULN, mean (SD) 0.014 (0.820) -0.004 (0.478) TABLE Pooled patient disposition, demographics and safety events of nine placebo-controlled trials[dagger] AE, adverse event; BMI, body mass index; CHD, coronary heart disease; CV, cardiovascular; HeFH, heterozygous familial hypercholesterolemia; MI, myocardial infarction; SD, standard deviation; TEAE, treatment-emergent adverse event; ULN, upper limit of normal
 Cardiovascular disease Cholesterol Diabetes Drug therapy Heart attacks Hospitalization Laboratories Studies

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