ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2018
Efficacy and Safety of Alirocumab in Individuals with Diabetes Mellitus: Pooled Analyses from Five Placebo-Controlled Phase 3 Studies.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of alirocumab among individuals with diabetes mellitus and atherosclerotic cardiovascular disease in the ODYSSEY phase 3 trials.Diabetes, obesity & metabolism · 2018Pooled it
- Efficacy and Safety of Alirocumab 300 mg Every 4 Weeks in Individuals With Type 2 Diabetes on Maximally Tolerated Statin.The Journal of clinical endocrinology and metabolism · 2019Trial
- Alirocumab vs usual lipid-lowering care as add-on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia: The ODYSSEY DM-DYSLIPIDEMIA randomized trial.Diabetes, obesity & metabolism · 2018Trial
- Improvement initiative in LDL-C management in Saudi Arabia: A call to action.International journal of cardiology. Heart & vasculature · 2020Review
- Cardiovascular Outcomes and Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors: Current Data and Future Prospects.Vascular health and risk management · 2020Review
- PEARL: A Non-interventional Study of Real-World Alirocumab Use in German Clinical Practice.Drugs - real world outcomes · 2019Article
- PCSK9 Inhibition: New Treatment Options and Perspectives to Lower Atherogenic Lipoprotein Particles and Cardiovascular Risk.Current atherosclerosis reports · 2019Review
- Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials.Diabetic medicine : a journal of the British Diabetic Association · 2018Article
- Diabetic Dyslipidemia: Epidemiology and Prevention of Cardiovascular Disease and Implications of Newer Therapies.Current cardiology reports · 2018Review
- Efficacy and safety of alirocumab in people with prediabetes vs those with normoglycaemia at baseline: a pooled analysis of 10 phase III ODYSSEY clinical trials.Diabetic medicine : a journal of the British Diabetic Association · 2018Article
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Authors and funding
10 authors.
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Abstract
introductionDiabetes 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.
methodsData 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.
resultsIn 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%).
conclusionsRegardless of DM status, alirocumab significantly reduced LDL-C levels; safety was generally similar.
fundingSanofi and Regeneron Pharmaceuticals, Inc. Plain language summary available for this article.
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