Efficacy and Safety of Alirocumab in Individuals with Diabetes Mellitus: Pooled Analyses from Five Placebo-Controlled Phase 3 Studies

Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders
Henry N GinsbergHelen M Colhoun

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; plac...Continue Reading

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Citations

Jan 24, 2019·Clinical Science·Natalie C WardGerald F Watts
Jul 28, 2019·Current Atherosclerosis Reports·Julia Brandts, Dirk Müller-Wieland
Jun 6, 2019·The Journal of Clinical Endocrinology and Metabolism·Dirk Müller-WielandEli M Roth
Jul 8, 2019·Drugs -- Real World Outcomes·Klaus G ParhoferW Dieter Paar
Jun 23, 2020·Current Medical Research and Opinion·Deborah R LeitnerRudolf Prager
Dec 1, 2018·Future Cardiology·Eli M Roth
Jan 3, 2020·Expert Opinion on Pharmacotherapy·Andrea PastaGian Marco Rosa

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Clinical Trials Mentioned

NCT02585778
NCT02642159
NCT01507831
NCT01617655
NCT01644175
NCT01623115
NCT01709500
NCT01663402

Software Mentioned

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