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- Title
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.
- Authors
Depre, Christophe; Antalik, Lubomir; Starling, Amaal; Koren, Michael; Eisele, Osaro; Lenz, Robert A.; Mikol, Daniel D.
- Abstract
Objective: To determine the potential impact of erenumab, a human anti‐calcitonin gene‐related peptide (CGRP) receptor monoclonal antibody, on total exercise time (TET), time to exercise‐induced angina, and ST depression in a double‐blind, placebo‐controlled study in patients with stable angina due to documented coronary artery disease. Background: The relative importance of the CGRP receptor pathway during myocardial ischemia has not been established. Methods: An exercise treadmill test was conducted following a single IV infusion of erenumab 140 mg or placebo. The primary endpoint was the change from baseline in exercise duration as measured by TET with a noninferiority margin of −90 seconds. Safety follow‐up visits occurred through week 12. Eighty‐eight participants were included in the analysis. Results: LS mean (SE) change in TET was −2.9 [14.8] seconds in the erenumab group and 8.1 [14.4] seconds in placebo; adjusted mean (90% CI) treatment difference was −11.0 (–44.9, 22.9) seconds. The CI lower bound (–44.9 sec) did not reach pre‐defined non‐inferiority margin of −90 seconds, demonstrating that TET change from baseline in the erenumab group was non‐inferior to placebo. There was no difference in time to exercise‐induced angina in erenumab and placebo groups (median [90% CI] time of 500 [420, 540] vs 508 [405, 572] seconds; hazard ratio [90% CI]: 1.11 [0.73, 1.69], P = .69) or time to onset of ≥1 mm ST‐segment depression (median [90% CI] time of 407 [380, 443] vs 420 [409,480] seconds; hazard ratio [95% CI]: 1.14 [0.76, 1.69], P = .59). Adverse events were reported by 27% and 32% of patients in erenumab and placebo groups. Conclusions: Erenumab did not adversely affect exercise time in a high cardiovascular risk population of patients, supporting that inhibition of the canonical CGRP receptor does not worsen myocardial ischemia.
- Subjects
CORONARY heart disease complications; ANGINA pectoris; VASODILATION; CARDIOPULMONARY system; CARDIOVASCULAR diseases risk factors; CONFIDENCE intervals; CORONARY disease; DRUG side effects; EXERCISE tests; INTRAVENOUS therapy; MONOCLONAL antibodies; TIME; RANDOMIZED controlled trials; BLIND experiment; EXERCISE intensity; EXERCISE tolerance; ODDS ratio
- Publication
Headache: The Journal of Head & Face Pain, 2018, Vol 58, Issue 5, p715
- ISSN
0017-8748
- Publication type
Article
- DOI
10.1111/head.13316