Migraine drug shows no increase in CV outcomes

The migraine medication galcanezumab didn't result in clinically meaningful differences in blood pressure, pulse, ECG results or an increase in CV events compared with placebo in a study presented at the American Academy of Neurology’s 2019 meeting in Philadelphia.

In research led by Tina Oakes and supported by Eli Lilly and Company, scientists examined data from two six-month migraine studies and one three-month chronic migraine study in an effort to assess the effect of galcanezumab on heart health. Galcanezumab, sold under the brand name Emgality, is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a microvascular vasodilator that could have a protective role in CV wellness.

Since increased cardiovascular risk has been noted in patients with migraines, Oakes and her co-authors wondered if galcanezumab might mitigate the negative CV symptoms associated with chronic headaches. The patients they studied were randomized 1:1:2 to an initial 240 mg loading dose of galcanezumab followed by subcutaneous injections of 120 mg/month, 240 mg/month or placebo. At baseline, the team grouped patients into “yes” or “no” CVD risk groups based on their reported medical history.

Between 17% and 19% of patients across all treatment groups were considered at risk for CVD at baseline, according to the Neurology study. Just 4% of patients reported one or more CV treatment-emergent adverse events (TEAEs) during the course of follow-up, and the same number of patients in the galcanezumab 240 mg group and placebo group experienced adverse CV events including pulmonary embolism, acute MI, deep vein thrombosis and transient ischemic attack.

No patients in the galcanezumab 120 mg cohort experienced an adverse CV event.

Oakes and co-authors said patients’ events weren’t considered treatment-related, and the team didn’t find any clinically meaningful differences in CV TEAEs, blood pressure, pulse or QTcF between galcanezumab and placebo groups.

Another Eli Lilly study slated for presentation at AAN 19 found galcanezumab 120 mg and 240 mg demonstrated a statistically significant reduction in monthly migraines for patients with both low- and high-frequency headaches when compared with a placebo. That study, however, didn’t consider any cardiovascular outcomes.