A Randomized, Placebo‐Controlled Study of the Effects of Telcagepant on Exercise Time in Patients With Stable Angina

Telcagepant is a calcitonin gene‐related peptide (CGRP) receptor antagonist being evaluated for acute migraine treatment. CGRP is a potent vasodilator that is elevated after myocardial infarction, and it delays ischemia during treadmill exercise. We tested the hypothesis that CGRP receptor antagonis...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2012-03, Vol.91 (3), p.459-466
Main Authors: Chaitman, B R, Ho, A P, Behm, M O, Rowe, J F, Palcza, J S, Laethem, T, Heirman, I, Panebianco, D L, Kobalava, Z, Martsevich, S Y, Free, A L, Bittar, N, Chrysant, S G, Ho, T W, Chodakewitz, J A, Murphy, M G, Blanchard, R L
Format: Article
Language:English
Subjects:
Angina, Stable - drug therapy
Angina, Stable - physiopathology
Azepines - therapeutic use
Cross-Over Studies
Double-Blind Method
Electrocardiography - methods
Exercise Test - methods
Female
Heart Rate - drug effects
Humans
Imidazoles - therapeutic use
Male
Middle Aged
Migraine Disorders - drug therapy
Receptors, Calcitonin Gene-Related Peptide - antagonists & inhibitors
Vasodilator Agents - therapeutic use
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Summary:Telcagepant is a calcitonin gene‐related peptide (CGRP) receptor antagonist being evaluated for acute migraine treatment. CGRP is a potent vasodilator that is elevated after myocardial infarction, and it delays ischemia during treadmill exercise. We tested the hypothesis that CGRP receptor antagonism does not reduce treadmill exercise time (TET). The effects of supratherapeutic doses of telcagepant on TET were assessed in a double‐blind, randomized, placebo‐controlled, two‐period, crossover study in patients with stable angina and reproducible exercise‐induced angina. Patients received telcagepant (600 mg, n = 46; and 900 mg, n = 14) or placebo and performed treadmill exercise at Tmax (2.5 h after the dose). The hypothesis that telcagepant does not reduce TET was supported if the lower bound of the two‐sided 90% confidence interval (CI) for the mean treatment difference (telcagepant–placebo) in TET was more than −60 s. There were no significant between‐treatment differences in TET (mean treatment difference: −6.90 (90% CI: −17.66, 3.86) seconds), maximum exercise heart rate, or time to 1‐mm ST‐segment depression using pooled data or with stratification for dose. Clinical Pharmacology & Therapeutics (2012); 91 3, 459–466. doi:10.1038/clpt.2011.246
ISSN:0009-9236
1532-6535
DOI:10.1038/clpt.2011.246