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


CONCLUSIONS
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.
Merck Sharp & Dohme Corp., Whitehouse Station, NJ 19454-1099, USA. tony.ho@merck.com
Tony W
TW
Ho
Andrew P
AP
Ho
Bernard R
BR
Chaitman
Constance
C
Johnson
Ninan T
NT
Mathew
James
J
Kost
Xiaoyin
X
Fan
Sheena K
SK
Aurora
Jan L
JL
Brandes
Kaiyin
K
Fei
Louise
L
Beebe
Christopher
C
Lines
Mitchell W
MW
Krucoff
D000328:Adult; D000368:Aged; D001381:Azepines / Q000627:therapeutic use*; D000077221:Calcitonin Gene-Related Peptide Receptor Antagonists; D003324:Coronary Artery Disease / Q000150:complications / Q000188:drug therapy*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000150:complications / Q000188:drug therapy*; D015233:Models, Statistical; D012720:Severity of Illness Index; D055815:Young Adult
D001381:Azepines; D000077221:Calcitonin Gene-Related Peptide Receptor Antagonists; D007093:Imidazoles; C525458:telcagepant