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.