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Efficacy and safety of alirocumab in insulin‐treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM‐INSULIN randomized trial
| Content Provider | Semantic Scholar |
|---|---|
| Author | Leiter, Lawrence A. Cariou, Bertrand Müller-Wieland, Dirk Colhoun, Helen M. Prato, Stefano Del Tinahones, Francisco José Ray, Kausik K. Bujas-Bobanovic, Maja Domenger, Catherine Mandel, Jonas Samuel, Rita Henry, Robert R. |
| Copyright Year | 2017 |
| Abstract | AIMS To investigate the efficacy and safety of alirocumab in participants with type 2 (T2D) or type 1 diabetes (T1D) treated with insulin who have elevated LDL cholesterol levels despite maximally tolerated statin therapy. METHODS Participants at high cardiovascular risk with T2D (n = 441) or T1D (n = 76) and LDL cholesterol levels ≥1.8 mmol/L (≥70 mg/dL) were randomized 2:1 to alirocumab:placebo administered subcutaneously every 2 weeks, for 24 weeks' double-blind treatment. Alirocumab-treated participants received 75 mg every 2 weeks, with blinded dose increase to 150 mg every 2 weeks at week 12 if week 8 LDL cholesterol levels were ≥1.8 mmol/L. Primary endpoints were percentage change in calculated LDL cholesterol from baseline to week 24, and safety assessments. RESULTS Alirocumab reduced LDL cholesterol from baseline to week 24 by a mean ± standard error of 49.0% ± 2.7% and 47.8% ± 6.5% vs placebo (both P < .0001) in participants with T2D and T1D, respectively. Significant reductions were observed in non-HDL cholesterol (P < .0001), apolipoprotein B (P < .0001) and lipoprotein (a) (P ≤ .0039). At week 24, 76.4% and 70.2% of the alirocumab group achieved LDL cholesterol <1.8 mmol/L in the T2D and T1D populations (P < .0001), respectively. Glycated haemoglobin and fasting plasma glucose levels remained stable for the study duration. Treatment-emergent adverse events were observed in 64.5% of alirocumab- vs 64.1% of placebo-treated individuals (overall population). CONCLUSIONS Alirocumab produced significant LDL cholesterol reductions in participants with insulin-treated diabetes regardless of diabetes type, and was generally well tolerated. Concomitant administration of alirocumab and insulin did not raise any safety concerns (NCT02585778). |
| Starting Page | 1781 |
| Ending Page | 1792 |
| Page Count | 12 |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/82/23/DOM-19-1781.PMC5698740.pdf |
| PubMed reference number | 28905478v1 |
| Alternate Webpage(s) | https://doi.org/10.1111/dom.13114 |
| DOI | 10.1111/dom.13114 |
| Journal | Diabetes, obesity & metabolism |
| Volume Number | 19 |
| Language | English |
| Access Restriction | Open |
| Subject Keyword | Adverse event Adverse reaction to drug BaseLine dental cement Blinded Cholesterol Diabetes Mellitus Diabetes Mellitus, Insulin-Dependent Diabetes Mellitus, Non-Insulin-Dependent Evaluation procedure Fetal Hemoglobin Glucose Lipoprotein (a) Lipoproteins Simvastatin alirocumab millimole |
| Content Type | Text |
| Resource Type | Article |
