Long-term cardiovascular safety of erenumab

In an analysis of 4 randomised trials and their open-label extensions, the safety of erenumab was assessed [1]. The frequency of cardiovascular and cerebrovascular adverse events (AEs) was comparable to that of placebo seen over 12 weeks. There was no increased emergence of AEs in up to 5 years of follow-up.

Dr Stewart Tepper (Geisel School of Medicine, USA) presented the results of the post-hoc analysis of AEs in erenumab users with episodic or chronic migraine with or without a history of aura. During the 12-week double-blind treatment phase, 2,443 patients were treated with erenumab (70 mg/140 mg once monthly) or placebo. Of these, 1,140 (47%) had a history of aura. Dr Tepper noted that vascular risk factors were more prominent in the aura subgroup. At baseline, ≥2 cardiovascular risk factors were present in 35% of patients with aura and 27% of patients without.

Cardiovascular and cerebrovascular AE rates were low throughout the controlled and open-label erenumab exposure of up to 5 years. During that period, these rates were the same among patients with aura (n=6; 0.4/100 patient years) and without aura (n=5; 0.3/100). Hypertension-related AE rates were similar in both subgroups (n=30; 2.3/100 patient-years and n=37; 2.2/100, respectively).

Rates of cardiovascular, cerebrovascular, and hypertension-related AEs, general AEs, and all serious AEs were similar in the placebo and erenumab treatment groups during the double-blind treatment phase, regardless of aura history. Dr Tepper concluded: “This is reassuring data”.

1. Tepper SJ, et al. Abstract O1016, EAN 2020.

 



Posted on 10 September 202023 April 2024