To evaluate cardiovascular safety of erenumab (erenumab-aooe in the US) in patients with migraine and aura.

Migraine with aura is associated with cardiovascular and cerebrovascular disease.

Safety of erenumab was assessed in a post hoc analysis of adverse events (AEs) from four double-blind, placebo-controlled studies and their open-label extensions in patients with episodic or chronic migraine with/without history of aura. Standardized search terms were used to identify cardio/cerebrovascular and hypertension AEs.

Of 2443 patients treated with erenumab (70 mg/140 mg QM) or placebo during double-blind treatment phase (DBTP), 1140 (47%) had history of aura. At baseline, ≥2 cardiovascular risk factors were present in more patients with aura than without (35% vs 27%). Vascular disease risk factors were more prominent in the aura subgroup, including diabetes (2.6% vs 1.0%), history of hypertension (8.2% vs 6.6%), high blood pressure (systolic > 140 mm Hg or diastolic > 90 mm Hg: 7.5% vs 6.1%), high lipids (triglyceride > 150 mg/dL: 26.7% vs 22.5%), and BMI > 30kg/m² (30.4% vs 20.6%). Both subgroups had elevated cholesterol (total cholesterol > 200 mg/dL, LDL > 130 mg/dL, or HDL < 40 mg/dL: 47.9% and 47.7%).

Cardio/cerebrovascular AE rates were low throughout erenumab exposure period (up to 256 weeks) with no differences among patients with or without aura (n=6; 0.4/100-patient-years and n=5; 0.3/100-patient-years). Hypertension-related AEs were reported at similar rates in both subgroups (n=30; 2.3/100-patient-years and n=37; 2.2/100-patient-years). Rates of cardio/cerebrovascular and hypertension-related AEs, general AEs, and all SAEs were similar between placebo and erenumab treatment groups during the 12-week DBTP regardless of aura history.