According to a randomized, double-blind, placebo-controlled, phase 2a study published in Headache, erenumab, a pharmacologic candidate for migraine prevention, does not increase the likelihood of patients undergoing myocardial ischemia.
A total of 89 adult patients with stable angina and limited exercise tolerance were recruited from 40 sites worldwide. Of the total number of patients recruited, 1 withdrew permission. Stable angina was defined as a minimum of 1 angina episode/month for at least 3 months. Limited exercise tolerance was ascertained by having eligible participants undergo 2 exercise tolerance tests (ETTs) that were limited by symptoms of myocardial ischemia.
Each patient was randomly assigned to receive either a one-time intravenous (IV) infusion of 140 mg erenumab or placebo. Multiple measurements were made as part of ETT, including total exercise time (TET). Follow-up visits to monitor medication safety occurred for 12 weeks after drug or placebo administration.
The primary endpoint of interest included the TET change from baseline with a noninferiority margin of −90 seconds. Secondary outcomes were time to onset of exercise-induced angina and time to onset of a ≥1-mm ST-segment depression during ETT.
In the erenumab group, the least squares (LS) mean change in TET was −2.9 (90% confidence interval [CI], −27.5 to 21.7) seconds whereas in the placebo group, LS mean change was 8.1 (90% CI, −15.8 to 32.0) seconds. The adjusted mean treatment difference was −11.0 (90% CI, −44.9 to 22.9) seconds.
Given that the lower-bound CI did not reach the noninferiority margin of −90 seconds, erenumab was determined to be noninferior to placebo with respect to the change from baseline TET. There was no difference between erenumab vs placebo on time to a ≥1-mm ST-segment depression during ETT (P =.59) or on the time to exercise-induced angina (P =.69).
In the erenumab group, 27% of patients reported adverse events, all of which were disease-related; 32% of patients in the placebo group reported adverse events as well, including one serious event of atrial fibrillation.
“These results in addition to the functional improvements and favorable safety and tolerability profiles of erenumab demonstrated in multiple clinical studies suggest that inhibition of the CRGP receptor by erenumab is a promising preventive treatment approach in patients with episodic and chronic migraine,” the authors wrote.
Disclosures. Funding for the study was provided by Amgen Inc. Several authors declare affiliations with the pharmaceutical industry; please refer to the full article for the list.
Depre C, Antalik L, Starling A, et al. A randomized, double-blind, placebo-controlled study to evaluate the effect of erenumab on exercise time during a treadmill test in patients with stable angina. Headache. 2018 May;58(5):715-723.