Long-Term Tolerability of Telcagepant for Acute Treatment of Migraine in a Randomized Trial

• Published in: Headache Vol. 51; no. 1; pp. 73 - 84
• Main Authors: Connor, Kathryn M., Aurora, Sheena K., Loeys, Tom, Ashina, Messoud, Jones, Christopher, Giezek, Hilde, Massaad, Rachid, Williams-Diaz, Angela, Lines, Christopher, Ho, Tony W.
• Format: Journal Article
• Language: English
• Published: Malden, USA Blackwell Publishing Inc 01.01.2011; Wiley-Blackwell; Wiley Subscription Services, Inc
• Subjects: Adult; Aged; Azepines - adverse effects; Azepines - therapeutic use; Biological and medical sciences; Cardiovascular system; CGRP; Double-Blind Method; Drug therapy; Endpoint Determination; FDA approval; Female; Headaches; Humans; Imidazoles - adverse effects; Imidazoles - therapeutic use; Indexing in process; Male; Medical sciences; Middle Aged; Migraine; Migraine Disorders - drug therapy; Neurology; Pharmacology. Drug treatments; Receptors, Calcitonin Gene-Related Peptide - antagonists & inhibitors; rizatriptan; safety; telcagepant; Triazoles - adverse effects; Triazoles - therapeutic use; Tryptamines - adverse effects; Tryptamines - therapeutic use; Vascular diseases and vascular malformations of the nervous system; Vasodilator agents. Cerebral vasodilators; Headache; Agonist; Nervous system diseases; Antimigrainous agent; Migraine; Tryptamine derivatives; Cardiovascular disease; 5-HT1 Serotonine receptor; Serotonine receptor; Serotonin agonist; Cerebral disorder; Vascular disease; Pain; Treatment; safety; Central nervous system disease; Triptan derivatives; Rizatriptan; Indole derivatives; Neurological disorder; CGRP; Cerebrovascular disease; telcagepant
• ISSN: 0017-8748; 1526-4610
• DOI: 10.1111/j.1526-4610.2010.01799.x

(Headache 2011;51:73‐84) Objective.— To evaluate the long‐term tolerability of telcagepant for acute treatment of intermittent migraine attacks. Background.— Telcagepant is a calcitonin gene‐related peptide (CGRP) receptor antagonist being investigated for the acute treatment of migraine. Methods.— Migraine patients were randomized 2:1 to double‐blind treatment with telcagepant 280/300 mg or rizatriptan 10 mg for an acute mild, moderate, or severe migraine. Patients could administer a second dose within 2‐24 hours for nonresponse or migraine recurrence. Patients could treat up to 8 attacks per month for up to 18 months. Safety assessments included spontaneous reports of adverse events and collection of vital signs, electrocardiograms, and laboratory assessments. The primary endpoint was the percentage of patients with ≥1 triptan‐related adverse events in the 14‐day period post dose. Results.— Of 1068 patients randomized, 641 (90%) patients treated ≥1 attack with telcagepant and 313 (88%) treated ≥1 attack with rizatriptan. A total of 19,820 attacks were treated with telcagepant (mean per patient = 31) and 10,981 with rizatriptan (mean per patient = 35). Fewer triptan‐related adverse events (difference: −6.2%; 95% CI −10.4, −2.6; P < .001) and drug‐related adverse events (difference: −15.6%; 95% CI −22.2, −9.0) were reported for telcagepant vs rizatriptan. The most common adverse events appeared to have generally similar incidence proportions between the treatment groups. Those with an incidence >5% in the telcagepant group were dry mouth (9.7%, rizatriptan = 13.7%), somnolence (9.2%, rizatriptan = 16.6%), dizziness (8.9%, rizatriptan = 10.2%), and nausea (9.0%, rizatriptan = 6.4%). Conclusions.— Telcagepant was generally well tolerated when administered for the acute intermittent treatment of migraine for up to 18 months. The incidences of triptan‐related and drug‐related adverse events favored telcagepant over rizatriptan.