Efficacy and Safety of Alirocumab in Diabetes Mellitus
Nasopharyngitis and upper respiratory tract infection were the most common treatment-emergent adverse events reported.
Alirocumab significantly lowered the low-density lipoprotein cholesterol levels of patients with and without diabetes without altering blood glucose levels and with similar rates of adverse reactions as those reported by placebo groups, according to a study published in Diabetes Therapy.
This subgroup analysis of 5 separate phase 3, placebo-controlled studies compared the safety and efficacy of alirocumab for patients with and without diabetes, with the primary end point goal being the reduction of low-density lipoprotein cholesterol from baseline to week 24. Of the 2416 patients treated with alirocumab, 30.1% had been diagnosed with diabetes at baseline, compared with 30.2% of patients in the placebo group.
Analyses showed that most individuals achieved <70 mg/dL of cholesterol after 24 weeks of alirocumab treatment, regardless of whether or not they had diabetes. Treatment with 75 mg alirocumab every 2 weeks resulted in 68.3% of individuals with diabetes reaching this end point goal, compared with 65.8% of individuals without diabetes. Treatment with 150 mg alirocumab every 2 weeks resulted in 78% of individuals with diabetes reaching this goal compared with 77% of individuals without diabetes.
Compared with 82% of individuals with diabetes in the placebo groups and 81% of individuals without diabetes in the placebo groups, 80% of individuals both with diabetes and without diabetes experienced adverse reactions with alirocumab treatment. Adverse reactions reported were also similar.
Study investigators conclude that “[diabetes] status does not appear to meaningfully affect lipid-modifying efficacy or safety of alirocumab treatment, nor does alirocumab appear to significantly affect blood glucose control in individuals with or without [diabetes].”
This study was supported by Sanofi and Regeneron Pharmaceuticals, Inc.
Ginsberg HN, Farnier M, Robinson JG, et al. Efficacy and safety of alirocumab in individuals with diabetes mellitus: pooled analyses from five placebo-controlled phase 3 studies. Diabetes Ther. 2018; 9(3):1317-1334.