3 years ago

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

Rita Samuel, Maja Bujas-Bobanovic, Dirk Müller-Wieland, Catherine Domenger, Kausik K. Ray, Helen M. Colhoun, Jonas Mandel, Francisco J. Tinahones, Robert R. Henry, Stefano Del Prato, Lawrence A. Leiter, Bertrand Cariou
Aims To investigate efficacy and safety of alirocumab in participants with type 2 or type 1 diabetes treated with insulin and with elevated low-density lipoprotein cholesterol (LDL-C) despite maximally tolerated statin therapy. Materials and Methods Participants at high cardiovascular risk with type 2 (n = 441) or type 1 diabetes (n = 76) and LDL-C ≥70 mg/dL (≥1.8 mmol/L) were randomized 2:1 to alirocumab:placebo administered subcutaneously every 2 weeks (Q2W), for 24 weeks’ double-blind treatment. Alirocumab-treated participants received a 75 mg Q2W dose, with blinded dose increase to 150 mg Q2W at week 12 if week 8 LDL-C ≥70 mg/dL. Primary endpoints were percentage change in calculated LDL-C from baseline to week 24, and safety assessments. Results Alirocumab reduced LDL-C from baseline to week 24 by (mean ± standard error) 49.0 ± 2.7% and 47.8 ± 6.5% vs placebo (both P<0.0001), in those with type 2 and type 1 diabetes, respectively. Significant reductions were observed in non-high-density-lipoprotein cholesterol (P<0.0001), apolipoprotein B (P<0.0001), and lipoprotein (a) (P≤0.0039). At week 24, 76.4% and 70.2% of the alirocumab group achieved LDL-C <70 mg/dL in the type 2 and type 1 diabetes populations (P<0.0001), 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-C 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).

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/dom.13114

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