Journal article
Efficacy and Safety of Alirocumab in Individuals with Diabetes Mellitus: Pooled Analyses from Five Placebo-Controlled Phase 3 Studies
Diabetes Therapy, Vol.9(3), pp.1317-1334
06/2018
DOI: 10.1007/s13300-018-0439-8
PMCID: PMC5984942
PMID: 29779195
Abstract
Diabetes mellitus (DM) carries an elevated risk for cardiovascular disease. Here, we assessed alirocumab efficacy and safety in people with/without DM from five placebo-controlled phase 3 studies.Data from up to 78 weeks were analyzed in individuals on maximally tolerated background statin. In three studies, alirocumab 75 mg every 2 weeks (Q2W) was increased to 150 mg Q2W at week 12 if week 8 low-density lipoprotein cholesterol (LDL-C) was ≥ 70 mg/dL; two studies used alirocumab 150 mg Q2W throughout. The primary endpoint was percentage change in LDL-C from baseline to week 24.In the alirocumab 150 mg pool (n = 2416), baseline LDL-C levels were 117.4 mg/dL (DM) and 130.6 mg/dL (without DM), and in the 75/150 mg pool (n = 1043) 112.8 mg/dL (DM) and 133.0 mg/dL (without DM). In the 150 mg Q2W group, week 24 LDL-C reductions from baseline were observed in persons with DM (− 59.9%; placebo, − 1.4%) and without DM (− 60.6%; placebo, + 1.5%); 77.7% (DM) and 76.8% (without DM) of subjects achieved LDL-C < 70 mg/dL. In the alirocumab 75/150 mg group, 26% (DM) and 36% (without DM) of subjects received dose increase. In this group, week 24 LDL-C levels changed from baseline by − 43.8% (DM; placebo, + 0.3%) and − 49.7% (without DM; placebo, + 5.1%); LDL-C < 70 mg/dL was achieved by 68.3% and 65.8% of individuals, respectively. At week 24, alirocumab was also associated with improved levels of other lipids. Adverse event rates were generally comparable in all groups (79.8–82.0%).Regardless of DM status, alirocumab significantly reduced LDL-C levels; safety was generally similar.Sanofi and Regeneron Pharmaceuticals, Inc.Plain language summary available for this article.
Details
- Title: Subtitle
- Efficacy and Safety of Alirocumab in Individuals with Diabetes Mellitus: Pooled Analyses from Five Placebo-Controlled Phase 3 Studies
- Creators
- Henry Ginsberg - 0000000419368729 grid.21729.3f Columbia University New York NY USAMichel Farnier - grid.31151.37 Point Medical and Department of Cardiology CHU Dijon-Bourgogne Dijon FranceJennifer Robinson - 0000 0004 1936 8294 grid.214572.7 University of Iowa Iowa City IA USAChristopher Cannon - 0000 0004 0422 1863 grid.488688.2 Harvard Clinical Research Institute Boston MA USANaveed Sattar - 0000 0001 2193 314X grid.8756.c University of Glasgow Glasgow UKMarie Baccara-Dinet - grid.417924.d Sanofi Montpellier FranceAlexia Letierce - grid.417924.d Sanofi Chilly-Mazarin FranceMaja Bujas-Bobanovic - grid.417924.d Sanofi Paris FranceMichael Louie - 0000 0004 0472 2713 grid.418961.3 Regeneron Pharmaceuticals Inc Tarrytown NY USAHelen Colhoun - 0000 0004 1936 7988 grid.4305.2 University of Edinburgh Edinburgh UK
- Resource Type
- Journal article
- Publication Details
- Diabetes Therapy, Vol.9(3), pp.1317-1334
- DOI
- 10.1007/s13300-018-0439-8
- PMID
- 29779195
- PMCID
- PMC5984942
- NLM abbreviation
- Diabetes Ther
- ISSN
- 1869-6953
- eISSN
- 1869-6961
- Publisher
- Springer Healthcare; Cheshire
- Grant note
- Sanofi (http://dx.doi.org/10.13039/100004339) Regeneron Pharmaceuticals, Inc.
- Language
- English
- Date published
- 06/2018
- Academic Unit
- Epidemiology; Fraternal Order of Eagles Diabetes Research Center; Internal Medicine
- Record Identifier
- 9983996060002771
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