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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.

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.

journal_name

Headache

journal_title

Headache

authors

Depre C,Antalik L,Starling A,Koren M,Eisele O,Lenz RA,Mikol DD

doi

10.1111/head.13316

subject

Has Abstract

pub_date

2018-05-01 00:00:00

pages

715-723

issue

eissn

0017-8748

issn

1526-4610

journal_volume

pub_type

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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.