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 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. © 2012 american Society for clinical Pharmacology and Therapeutics.

Chaitman B.R.1 , Ho A.P.2, 3, 4 , Behm M.O.2, 3, 4 , Rowe J.F.2, 3, 4 , Palcza J.S.2, 3, 4 , Laethem T.5 , Heirman I.5 , Panebianco D.L.2, 3, 4 , Kobalava Z. 6 , Martsevich S.Y.7 , Free A.L.8 , Bittar N.9 , Chrysant S.G.10 , Ho T.W.2, 3, 4 , Chodakewitz J.A.2, 3, 4 , Murphy M.G.2, 3, 4 , Blanchard R.L.2, 3, 4
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  • 1 Division of Cardiology, St Louis University School of Medicine, St Louis, MO, United States
  • 2 Department of Clinical Pharmacology, Merck Sharp and Dohme Corp., Whitehouse Station, NJ, United States
  • 3 Department of Clinical Neuroscience Research, Merck Sharp and Dohme Corp., Whitehouse Station, NJ, United States
  • 4 Department of Early Development Statistics, Merck Sharp and Dohme Corp., Whitehouse Station, NJ, United States
  • 5 Department of Clinical Pharmacology, MSD, Brussels, Belgium
  • 6 Peoples' Friendship University of Russia, Moscow, Russian Federation
  • 7 Center for Prophylactic Medicine, Rosmed Technology, Moscow, Russian Federation
  • 8 Pinnacle Research Group, Anniston, AL, United States
  • 9 Gemini Scientific, Madison, WI, United States
  • 10 Oklahoma Cardiovascular and Hypertension Center, University of Oklahoma, Oklahoma City, OK, United States
placebo; telcagepant; adult; aged; article; confidence interval; controlled study; crossover procedure; double blind procedure; female; flushing; headache; heart rate; heart ventricle extrasystole; human; major clinical study; male; phase 1 clinical trial; priority journal; randomized controlled trial; side effect; stable angina pectoris; time; time to maximum plasma concentration; treadmill exercise time; Angina, Stable; Azepines; Cross-Over Studies; Double-Blind Method; Electrocardiography; Exercise Test; Female; Heart Rate; Humans; Imidazoles; Male; Middle Aged; Migraine Disorders; Receptors, Calcitonin Gene-Related Peptide; Vasodilator Agents
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