In a pooled analysis of three randomized phase 3 trials, fremanezumab was well-tolerated and showed a good overall and cardio- and cerebrovascular safety profile over 12 weeks in people with migraine, irrespective of medication usage, cardio- and cerebrovascular medical history, and cardiovascular risk factors. Hans Christoph Diener et al. aimed to determine the tolerability and safety of fremanezumab to treat migraine.

A total of 2842 patients (18 to 70 years of age) suffering from episodic or chronic migraine and who were treated with monthly fremanezumab, quarterly fremanezumab, or placebo were incorporated in the study. Analysis of overall and serious side effects was performed. In the subgroups that were stratified by cerebro- and cardiovascular medications or triptans usage, cardiovascular risk factors, and cerebro- and cardiovascular medical history, an evaluation of cerebro- and cardiovascular adverse events (CVAEs) was also done.

The severe (<1–2%) and overall side effects (58–65%) and  took place in a similar percentage across placebo and fremanezumab groups. Cardiovascular adverse events were infrequent, irrespective of cerebro- and cardiovascular medical history, and took place in low, similar percentage of people with cardiovascular risk factors, and those utilizing cerebro- and cardiovascular medications or triptans. Cerebro- and cardiovascular signals were not identified.

Hence, this study supported the fully-humanized monoclonal antibody fremanezumab as reasonable for preventive migraine therapy in people having migraine regardless of their cardiovascular clinical features.