Leiter LA, et al. - This study was undertaken to evaluate 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. It has been validated that alirocumab produced significant LDL-C reductions in participants with insulin-treated diabetes regardless of diabetes type, and was generally well tolerated. The data showed that concomitant administration of alirocumab and insulin did not raise any safety concerns.

Methods

• In this study, subjects 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 assigned randomly 2:1 to alirocumab:placebo administered subcutaneously every 2 weeks (Q2W), for 24 weeks’ double-blind treatment.
• Thereafter, 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.
• Percentage change in calculated LDL-C from baseline to week 24, and safety assessments were considered as primary outcomes.

Results

• The data indicated that 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.
• They found significant reductions in non-high-density-lipoprotein cholesterol (P<0.0001), apolipoprotein B (P<0.0001), and lipoprotein (a) (P ≤0.0039).
• The evidence showed that 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 at week 24.
• It was noted that glycated haemoglobin and fasting plasma glucose levels remained stable for the study duration.
• They observed treatment-emergent adverse events in 64.5% of alirocumab vs 64.1% of placebo treated individuals (overall population).