Efficacy and safety of alirocumab in individuals with Diabetes Mellitus: pooled analyses from five placebo-controlled phase 3 studies

Ginsberg, H. N., Farnier, M., Robinson, J. G., Cannon, C. P., Sattar, N. , Baccara-Dinet, M. T., Letierce, A., Bujas-Bobanovic, M., Louie, M. J. and Colhoun, H. M. (2018) Efficacy and safety of alirocumab in individuals with Diabetes Mellitus: pooled analyses from five placebo-controlled phase 3 studies. Diabetes Therapy, 9(3), pp. 1317-1334. (doi: 10.1007/s13300-018-0439-8) (PMID:29779195) (PMCID:PMC5984942)

Abstract

Introduction: 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. Methods: 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. Results: 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%). Conclusions: Regardless of DM status, alirocumab significantly reduced LDL-C levels; safety was generally similar. Funding: Sanofi and Regeneron Pharmaceuticals, Inc.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Sattar, Professor Naveed
• Authors: Ginsberg, H. N., Farnier, M., Robinson, J. G., Cannon, C. P., Sattar, N., Baccara-Dinet, M. T., Letierce, A., Bujas-Bobanovic, M., Louie, M. J., and Colhoun, H. M.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: Diabetes Therapy
• Publisher: Springer
• ISSN: 1869-6953
• ISSN (Online): 1869-6961
• Published Online: 19 May 2018
• Copyright Holders: Copyright © 2018 The Authors
• First Published: First published in Diabetes Therapy 9(3): 1317-1334
• Publisher Policy: Reproduced under a Creative Commons License

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