The following article is part of coverage from the American Academy of Neurology’s Annual Meeting (AAN 2020). Due to the global COVID-19 pandemic, the Academy made the necessary decision to cancel the meeting originally scheduled for April 25–May 1, 2020, in Toronto. While live events will not proceed as planned, readers can click here catch up on the latest research intended to be presented at the meeting.
Treatment with fremanezumab for episodic and chronic migraine was found to have a favorable cardiovascular safety profile in patients with and without a history of cardiovascular disease, according to study results intended to be presented at the annual meeting of the American Academy of Neurology (AAN 2020).
Fremanezumab is a monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP) pathway. Given the vasodilatory properties of CGRP, the researchers aimed to explore the cardiovascular safety and tolerability of fremanezumab in patients with episodic or chronic migraine.
The researchers used data from the 2 HALO studies that included patients with episodic and chronic migraine, and the FOCUS study that included patients with either type of migraine and inadequate response to 2 to 4 classes of preventive medications. In all 3 trials, the participants were randomly assigned in a 1:1:1 fashion to receive quarterly subcutaneous injections of fremanezumab (all participants received fremanezumab 675 mg in month 1 and placebo in months 2 and 3), fremanezumab monthly (fremanezumab 675 mg for participants with chronic migraine and 225 mg in those with episodic migraine in the first month, followed by fremanezumab 225 mg in months 2 and 3 in both groups), or matched placebo over 12 weeks.
Among the study participants, prior cardiovascular disease was documented in 167 of those who received quarterly fremanezumab, 64 participants with episodic migraine who received monthly fremanezumab (225mg/225mg/225mg), 94 with chronic migraine who received monthly fremanezumab (675mg/225mg/225mg), and 153 in the placebo group. Cardiovascular adverse events were not frequent and similar in all groups (4%, 6%, 6%, and 3%, respectively).
Among participants with a prior history of cardiovascular disease, the most common cardiovascular adverse events included hypertension (2% of those treated with quarterly fremanezumab, 2% of those with episodic migraine treated with monthly fremanezumab, 0% of participants with chronic migraine treated with monthly fremanezumab, and <1% of those in the placebo group).
Of the participants without a history of cardiovascular disease, 776 received quarterly fremanezumab, 337 with episodic migraine received monthly fremanezumab (225mg/225mg/225mg), 459 with chronic migraine received monthly fremanezumab (675mg/225mg/225mg), and 792 were in the placebo group. Among participants without a prior history of cardiovascular disease, cardiovascular adverse events were also not frequent and occurred in similar percentages of participants across treatment groups (2%, 1%, 2%, and 2%, respectively).
“Pooled data from three phase 3 trials indicate that treatment with fremanezumab over 12 weeks has a favorable cardiovascular safety profile, even in patients with a cardiovascular medical history, with no safety signals detected”, concluded the researchers.
Nahas SJ, Kessler Y, Ning X, et al. Cardiovascular safety of fremanezumab in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. Intended to be presented at the 2020 annual meeting of the American Academy of Neurology. Abstract S8.004.
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