A randomized, placebo-controlled study of the effects of telcagepant on exercise time in patients with stable angina

B. R. Chaitman; A. P. Ho; M. O. Behm; J. F. Rowe; J. S. Palcza; T. Laethem; I. Heirman; D. L. Panebianco; Z. Kobalava; S. Y. Martsevich; A. L. Free; N. Bittar; S. G. Chrysant; T. W. Ho; J. A. Chodakewitz; M. G. Murphy; R. L. Blanchard

doi:10.1038/clpt.2011.246

A randomized, placebo-controlled study of the effects of telcagepant on exercise time in patients with stable angina

B. R. Chaitman, A. P. Ho, M. O. Behm, J. F. Rowe, J. S. Palcza, T. Laethem, I. Heirman, D. L. Panebianco, Z. Kobalava, S. Y. Martsevich, A. L. Free, N. Bittar, S. G. Chrysant, T. W. Ho, J. A. Chodakewitz, M. G. Murphy, R. L. Blanchard

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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.

Original language	English (US)
Pages (from-to)	459-466
Number of pages	8
Journal	Clinical pharmacology and therapeutics
Volume	91
Issue number	3
DOIs	https://doi.org/10.1038/clpt.2011.246
State	Published - Mar 2012
Externally published	Yes

ASJC Scopus subject areas

Pharmacology
Pharmacology (medical)

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10.1038/clpt.2011.246

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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. (2012). A randomized, placebo-controlled study of the effects of telcagepant on exercise time in patients with stable angina. Clinical pharmacology and therapeutics, 91(3), 459-466. https://doi.org/10.1038/clpt.2011.246

Chaitman, BR, Ho, AP, Behm, MO, Rowe, JF, Palcza, JS, Laethem, T, Heirman, I, Panebianco, DL, Kobalava, Z, Martsevich, SY, Free, AL, Bittar, N, Chrysant, SG, Ho, TW, Chodakewitz, JA, Murphy, MG & Blanchard, RL 2012, 'A randomized, placebo-controlled study of the effects of telcagepant on exercise time in patients with stable angina', Clinical pharmacology and therapeutics, vol. 91, no. 3, pp. 459-466. https://doi.org/10.1038/clpt.2011.246

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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.",

author = "Chaitman, {B. R.} and Ho, {A. P.} and Behm, {M. O.} and Rowe, {J. F.} and Palcza, {J. S.} and T. Laethem and I. Heirman and Panebianco, {D. L.} and Z. Kobalava and Martsevich, {S. Y.} and Free, {A. L.} and N. Bittar and Chrysant, {S. G.} and Ho, {T. W.} and Chodakewitz, {J. A.} and Murphy, {M. G.} and Blanchard, {R. L.}",

note = "Funding Information: Acknowledgments. This work was supported by the Project US-AID/PSTC 6041/ISP/UO and by lNICT, PRAXIS, British Council, and EUREKA Program to which the authors are grateful.",

year = "2012",

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doi = "10.1038/clpt.2011.246",

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AU - Chaitman, B. R.

AU - Ho, A. P.

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AU - Rowe, J. F.

AU - Palcza, J. S.

AU - Laethem, T.

AU - Heirman, I.

AU - Panebianco, D. L.

AU - Kobalava, Z.

AU - Martsevich, S. Y.

AU - Free, A. L.

AU - Bittar, N.

AU - Chrysant, S. G.

AU - Ho, T. W.

AU - Chodakewitz, J. A.

AU - Murphy, M. G.

AU - Blanchard, R. L.

N1 - Funding Information: Acknowledgments. This work was supported by the Project US-AID/PSTC 6041/ISP/UO and by lNICT, PRAXIS, British Council, and EUREKA Program to which the authors are grateful.

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A randomized, placebo-controlled study of the effects of telcagepant on exercise time in patients with stable angina

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