Effect of telcagepant on spontaneous ischemia in cardiovascular patients in a randomized study

Martin O. Behm, Rebecca L. Blanchard, M. Gail Murphy, John S. Palcza, Dawn E. Harris, Kristin L. Butterfield, William Smith, Richard A. Preston, Jeffrey A. Chodakewitz, Mitchell W. Krucoff

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

(Objective.- The primary purpose of the study was to explore the safety and tolerability of telcagepant in patients with stable coronary artery disease. Background.- Triptans are effective acute anti-migraine drugs whose vasoconstrictive effects limit their use in patients at risk for adverse cardiovascular events. Telcagepant, a calcitonin gene-related peptide receptor antagonist, is being developed for the acute treatment of migraine. Antagonism of calcitonin gene-related peptide, which does not appear to cause vasoconstriction, may allow for treatment of migraine in patients with coronary artery disease. Methods.- In this randomized, double-blind, placebo-controlled, crossover study, patients with documented stable coronary artery disease were assigned to 1 of 2 treatment sequences: telcagepant then placebo, or placebo then telcagepant. In each treatment period, patients received 2 doses of telcagepant 300 mg or placebo 2 hours apart. They remained in the research center for 24 hours after receiving the first dose of each period, during which time continuous 12-lead ambulatory electrocardiographic (Holter) monitoring was performed. Results.- Twenty-eight patients were enrolled; all patients completed the study and were included in all analyses. Telcagepant was generally well tolerated. No laboratory or serious adverse experiences were reported, and no patient discontinued due to an adverse experience. There were no consistent treatment-related changes in laboratory, vital signs or electrocardiogram safety parameters. Three patients (2 after receiving placebo and 1 after receiving telcagepant) experienced ST segment depression during the study; none of these patients reported chest pain. Conclusions.- Two doses of 300-mg telcagepant, administered 2 hours apart, did not appear to exacerbate spontaneous ischemia and were generally well tolerated in a small cohort of patients with stable coronary artery disease. Results of this study support further evaluation of telcagepant in patients with stable coronary artery disease.

Original languageEnglish (US)
Pages (from-to)954-960
Number of pages7
JournalHeadache
Volume51
Issue number6
DOIs
StatePublished - Jun 1 2011

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Ischemia
Coronary Artery Disease
Placebos
Migraine Disorders
Ambulatory Electrocardiography
telcagepant
Calcitonin Gene-Related Peptide Receptors
Tryptamines
Therapeutics
Safety
Vital Signs
Calcitonin Gene-Related Peptide
Vasoconstriction
Chest Pain
Cross-Over Studies
Electrocardiography
Research
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Neurology
  • Clinical Neurology

Cite this

Behm, M. O., Blanchard, R. L., Murphy, M. G., Palcza, J. S., Harris, D. E., Butterfield, K. L., ... Krucoff, M. W. (2011). Effect of telcagepant on spontaneous ischemia in cardiovascular patients in a randomized study. Headache, 51(6), 954-960. https://doi.org/10.1111/j.1526-4610.2011.01901.x

Effect of telcagepant on spontaneous ischemia in cardiovascular patients in a randomized study. / Behm, Martin O.; Blanchard, Rebecca L.; Murphy, M. Gail; Palcza, John S.; Harris, Dawn E.; Butterfield, Kristin L.; Smith, William; Preston, Richard A.; Chodakewitz, Jeffrey A.; Krucoff, Mitchell W.

In: Headache, Vol. 51, No. 6, 01.06.2011, p. 954-960.

Research output: Contribution to journalArticle

Behm, MO, Blanchard, RL, Murphy, MG, Palcza, JS, Harris, DE, Butterfield, KL, Smith, W, Preston, RA, Chodakewitz, JA & Krucoff, MW 2011, 'Effect of telcagepant on spontaneous ischemia in cardiovascular patients in a randomized study', Headache, vol. 51, no. 6, pp. 954-960. https://doi.org/10.1111/j.1526-4610.2011.01901.x
Behm MO, Blanchard RL, Murphy MG, Palcza JS, Harris DE, Butterfield KL et al. Effect of telcagepant on spontaneous ischemia in cardiovascular patients in a randomized study. Headache. 2011 Jun 1;51(6):954-960. https://doi.org/10.1111/j.1526-4610.2011.01901.x
Behm, Martin O. ; Blanchard, Rebecca L. ; Murphy, M. Gail ; Palcza, John S. ; Harris, Dawn E. ; Butterfield, Kristin L. ; Smith, William ; Preston, Richard A. ; Chodakewitz, Jeffrey A. ; Krucoff, Mitchell W. / Effect of telcagepant on spontaneous ischemia in cardiovascular patients in a randomized study. In: Headache. 2011 ; Vol. 51, No. 6. pp. 954-960.
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abstract = "(Objective.- The primary purpose of the study was to explore the safety and tolerability of telcagepant in patients with stable coronary artery disease. Background.- Triptans are effective acute anti-migraine drugs whose vasoconstrictive effects limit their use in patients at risk for adverse cardiovascular events. Telcagepant, a calcitonin gene-related peptide receptor antagonist, is being developed for the acute treatment of migraine. Antagonism of calcitonin gene-related peptide, which does not appear to cause vasoconstriction, may allow for treatment of migraine in patients with coronary artery disease. Methods.- In this randomized, double-blind, placebo-controlled, crossover study, patients with documented stable coronary artery disease were assigned to 1 of 2 treatment sequences: telcagepant then placebo, or placebo then telcagepant. In each treatment period, patients received 2 doses of telcagepant 300 mg or placebo 2 hours apart. They remained in the research center for 24 hours after receiving the first dose of each period, during which time continuous 12-lead ambulatory electrocardiographic (Holter) monitoring was performed. Results.- Twenty-eight patients were enrolled; all patients completed the study and were included in all analyses. Telcagepant was generally well tolerated. No laboratory or serious adverse experiences were reported, and no patient discontinued due to an adverse experience. There were no consistent treatment-related changes in laboratory, vital signs or electrocardiogram safety parameters. Three patients (2 after receiving placebo and 1 after receiving telcagepant) experienced ST segment depression during the study; none of these patients reported chest pain. Conclusions.- Two doses of 300-mg telcagepant, administered 2 hours apart, did not appear to exacerbate spontaneous ischemia and were generally well tolerated in a small cohort of patients with stable coronary artery disease. Results of this study support further evaluation of telcagepant in patients with stable coronary artery disease.",
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AU - Behm, Martin O.

AU - Blanchard, Rebecca L.

AU - Murphy, M. Gail

AU - Palcza, John S.

AU - Harris, Dawn E.

AU - Butterfield, Kristin L.

AU - Smith, William

AU - Preston, Richard A.

AU - Chodakewitz, Jeffrey A.

AU - Krucoff, Mitchell W.

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