Galcanezumab treatment in migraine not associated with adverse CV events

USA: Treatment with galcanezumab for 6 months in patients with migraine does not result in adverse cardiovascular events out of proportion to placebo, finds a recent study published in the journal Headache.

According to this 6‐month treatment trial, the percentages of galcanezumab‐ and placebo‐treated patients that reported CV TEAEs (cardiovascular treatment‐emergent adverse events) or serious adverse events were low and similar between groups with few discontinuations.

Galcanezumab is a humanized IgG4 monoclonal antibody that binds calcitonin gene‐related peptide (CGRP) and prevents its biological activity without blocking the CGRP receptor. It is approved in the US and EU for the preventive treatment of migraine in adults. However, increased CV risks including ischemic stroke, transient ischemic attack (TIA), ischemic heart disease, and myocardial infarction (MI) have been reported in migraine patients.

Tina M. Oakes, Eli Lilly and Company, Indianapolis, IN, USA, and colleagues evaluated blood pressure (BP), pulse, electrocardiogram (ECG), and clinical cardiovascular (CV) outcomes in patients with episodic or chronic migraine treated for up to 6 months with galcanezumab compared to placebo were evaluated.

For the purpose, the researchers pooled data from patients randomized (1:1:2) to subcutaneous injection of galcanezumab 120 mg/month (following initial 240 mg loading dose) or 240 mg/month or placebo in 2 2 similarly designed episodic migraine 6‐month studies and 1 chronic migraine 3‐month study.

They then evaluated treatment comparisons for CV TEAE and categorical and mean changes in BP, pulse, and ECG using the Cochran‐Mantel‐Haenszel test. Mean changes from baseline in BP, pulse, and ECG were evaluated using the analysis of covariance model.

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Key findings of the study include:

• Among galcanezumab 120 mg (n = 705) and 240 mg (n = 730), and placebo (n = 1451) groups, the percentage of patients reporting ≥1 CV TEAE was low and was similar between the galcanezumab 120 mg (2.6%; odds ratio [OR] = 0.9) and galcanezumab 240 mg (3.3%; OR = 1.1), and placebo (2.9%) groups.


• The frequency of any individual CV TEAE, broad or narrow term, was ≤1.4%.


• The CV‐related serious adverse events that occurred in the galcanezumab 240 mg group (n = 3; acute myocardial infarction, pulmonary embolism, and transient ischemic attack) and placebo group (n = 3; pulmonary embolism, deep vein thrombosis, and myocardial infarction) were not considered treatment-related.


• Four placebo‐ and 1 galcanezumab‐treated patients discontinued due to a CV TEAE.


• Least squares mean and categorical changes from baseline in BP, pulse, and QT interval corrected using Fridericia's correction were similar across treatment groups.

"No clinically meaningful treatment group differences were observed for changes in BP, pulse, or ECG parameters. Additional longer‐term studies in a broader and larger cohort are required to better characterize CV safety," concluded the authors.

The study, "Evaluation of Cardiovascular Outcomes in Adult Patients With Episodic or Chronic Migraine Treated With Galcanezumab: Data From Three Phase 3, Randomized, Double‐Blind, Placebo‐Controlled EVOLVE‐1, EVOLVE‐2, and REGAIN Studies," is published in the journal Headache.

DOI: https://doi.org/10.1111/head.13684