The following article is part of conference coverage from the 2019 American Academy of Neurology Annual Meeting (AAN 2019) in Philadelphia, PA. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AAN 2019.
PHILADELPHIA — In patients with episodic or chronic migraine, treatment with galcanezumab did not result in clinically meaningful differences compared to placebo in blood pressure, pulse or ECG, or in an increased frequency of CV events, including those related to ischemia , according to research presented at the 2019 American Academy of Neurology Annual Meeting, held May 4-10, 2019, in Philadelphia, Pennsylvania.
Researchers evaluated the effect of galcanezumab, a monoclonal antibody that binds to calcitonin gene-related peptide, on cardiovascular health using data from 2 episodic migraine studies and 1 chronic migraine study. All 3 studies were phase 3, randomized, double-blinded, placebo-controlled, trials.
Patients were randomly assigned to either a treatment arm of galcanezumab 120 mg per month, galcanezumab 240 mg per month, or a placebo arm. All participants were categorized as either being at risk for cardiovascular disease (CVD) or not being at risk for CVD at baseline. The Cochran Mantel Haenszel test assessed potential cardiovascular treatment-emergent adverse events and analysis of covariance assessed changes from baseline.
In all of the study arms, 17% to 19% of patients were categorized as being at risk for CVD at baseline and <4% of the patients reported ≥1 cardiovascular treatment-emergent adverse event over the course of the study. A cardiovascular-related serious adverse event was reported in 3 patients in the galcanezumab 240 mg per month treatment arm, 3 patients in the placebo arm, and 0 patients in the galcanezumab 120 mg per month treatment arm. Changes from baseline were similar between all 3 study arms.
The researchers concluded that “[n]o clinically meaningful differences were observed for [cardiovascular treatment-emergent adverse events], [blood pressure], pulse, or [QT interval corrected by Fridericia’s formula] between patients treated with galcanezumab or placebo.”
Disclosure: Findings presented in this study were supported by Eli Lilly and Company and several authors report multiple associations with pharmaceutical companies. Please see the original reference for a full list of authors’ disclosures.
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Oakes T, Kovacs R, Rosen N, et al. Evaluation of cardiovascular risks in adult patients with episodic or chronic migraine treated with galcanezumab: data from three phase 3, randomized, double-blind, placebo-controlled studies. Presented at: 2019 American Academy of Neurology Annual Meeting; May 4-10, 2019; Philadelphia, PA. Abstract P1.10-010.