title: A randomized, placebo-controlled study of the effects of telcagepant on exercise time in patients with stable angina.
abstract: 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 T(max) (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.
authors.affiliation: Division of Cardiology, St Louis University School of Medicine, St Louis, Missouri, USA.
authors.forename: B R
authors.initials: BR
authors.lastname: Chaitman
authors.forename: A P
authors.initials: AP
authors.lastname: Ho
authors.forename: M O
authors.initials: MO
authors.lastname: Behm
authors.forename: J F
authors.initials: JF
authors.lastname: Rowe
authors.forename: J S
authors.initials: JS
authors.lastname: Palcza
authors.forename: T
authors.initials: T
authors.lastname: Laethem
authors.forename: I
authors.initials: I
authors.lastname: Heirman
authors.forename: D L
authors.initials: DL
authors.lastname: Panebianco
authors.forename: Z
authors.initials: Z
authors.lastname: Kobalava
authors.forename: S Y
authors.initials: SY
authors.lastname: Martsevich
authors.forename: A L
authors.initials: AL
authors.lastname: Free
authors.forename: N
authors.initials: N
authors.lastname: Bittar
authors.forename: S G
authors.initials: SG
authors.lastname: Chrysant
authors.forename: T W
authors.initials: TW
authors.lastname: Ho
authors.forename: J A
authors.initials: JA
authors.lastname: Chodakewitz
authors.forename: M G
authors.initials: MG
authors.lastname: Murphy
authors.forename: R L
authors.initials: RL
authors.lastname: Blanchard
mesh_terms: D060050:Angina, Stable / Q000188:drug therapy* / Q000503:physiopathology; D001381:Azepines / Q000627:therapeutic use*; D000077221:Calcitonin Gene-Related Peptide Receptor Antagonists; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004562:Electrocardiography / Q000379:methods; D005080:Exercise Test / Q000379:methods*; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy; D014665:Vasodilator Agents / Q000627:therapeutic use
chemical_list: D001381:Azepines; D000077221:Calcitonin Gene-Related Peptide Receptor Antagonists; D007093:Imidazoles; D014665:Vasodilator Agents; C525458:telcagepant