Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial.
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.
Merck, North Wales, PA 19454-1099, USA.
Kathryn M
KM
Connor
Sheena K
SK
Aurora
Tom
T
Loeys
Messoud
M
Ashina
Christopher
C
Jones
Hilde
H
Giezek
Rachid
R
Massaad
Angela
A
Williams-Diaz
Christopher
C
Lines
Tony W
TW
Ho
D000328:Adult; D000368:Aged; D001381:Azepines / Q000009:adverse effects* / Q000627:therapeutic use; D000077221:Calcitonin Gene-Related Peptide Receptor Antagonists; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D014230:Triazoles / Q000009:adverse effects / Q000627:therapeutic use; D014363:Tryptamines / Q000009:adverse effects / Q000627:therapeutic use
D001381:Azepines; D000077221:Calcitonin Gene-Related Peptide Receptor Antagonists; D007093:Imidazoles; D014230:Triazoles; D014363:Tryptamines; C093622:rizatriptan; C525458:telcagepant