Randomized, controlled study of telcagepant in patients with migraine and coronary artery disease.

Abstract

OBJECTIVE:

To evaluate the efficacy of telcagepant in patients with migraine and coronary artery disease.

BACKGROUND:

Calcitonin gene-related peptide receptor antagonists, such as telcagepant, may be useful for acute migraine treatment in patients with cardiovascular disease, a population for whom triptans are contraindicated.

METHODS:

Randomized, double-blind, two-period (6 weeks per period) crossover study in patients with stable coronary artery disease and migraine. Patients were randomized 1:1 to either: (1) Period 1: telcagepant (280-mg tablet/300-mg capsule), Period 2: acetaminophen (1000-mg); or (2) Period 1: placebo for attack 1 then acetaminophen for subsequent attacks, Period 2: telcagepant. Patients could treat up to 12 migraine attacks per period to assess the tolerability of telcagepant. The primary efficacy analysis evaluated telcagepant vs placebo on 2-hour pain freedom during the first attack of Period 1.

RESULTS:

One hundred and sixty-five of the planned 400 patients were enrolled, and 114 took at least one dose of treatment. Telcagepant was not statistically different from placebo for 2-hour pain freedom (25.0% vs 18.9%, odds ratio = 1.62 [95% confidence interval: 0.62, 4.25]). The median number of attacks treated per period was 3. No cardiovascular thrombotic adverse events occurred within 14 days of dosing.

CONCLUSION:

The study was underpowered due to enrollment difficulties and did not demonstrate a significant efficacy difference between telcagepant and placebo for the treatment of a migraine attack in patients with stable coronary artery disease. Telcagepant was generally well tolerated for acute intermittent migraine treatment in these patients.

• Authors: Tony W Ho, Andrew P Ho, Bernard R Chaitman, Constance Johnson, Ninan T Mathew, James Kost, Xiaoyin Fan, Sheena K Aurora, Jan L Brandes, Kaiyin Fei, Louise Beebe, Christopher Lines, Mitchell W Krucoff
• Journal: Headache (Headache) Vol. 52 Issue 2 Pg. 224-35 (Feb 2012) ISSN: 1526-4610 [Electronic] United States
• PMID: 22221076 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2011 American Headache Society.

Chemical References

• Azepines
• Calcitonin Gene-Related Peptide Receptor Antagonists
• Imidazoles
• telcagepant

Topics

• Adult
• Aged
• Azepines (therapeutic use)
• Calcitonin Gene-Related Peptide Receptor Antagonists
• Coronary Artery Disease (complications, drug therapy)
• Cross-Over Studies
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Imidazoles (therapeutic use)
• International Cooperation
• Male
• Middle Aged
• Migraine Disorders (complications, drug therapy)
• Models, Statistical
• Severity of Illness Index
• Young Adult