Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders.

Abstract

OBJECTIVE:

The study was carried out to assess the efficacy and tolerability of rizatriptan orally disintegrating tablet (ODT) for treating acute migraine in patients who are non-responders to sumatriptan.

BACKGROUND:

Many migraineurs report dissatisfaction with sumatriptan efficacy. It is unclear whether sumatriptan 100 mg non-responders will respond to other triptans.

METHODS:

This was a randomized, placebo-controlled, double-blind study in adults with >1-year history of ICHD-II (International Classification of Headache Disorders, second edition) migraine who reported that they generally do not respond to sumatriptan (≥50% unsatisfactory response). In the baseline phase, participants treated a single moderate/severe migraine attack with open-label generic sumatriptan 100 mg. Those who continued to experience moderate/severe pain at two hours post-dose were eligible to enter the double-blind treatment phase, during which participants treated three migraine attacks in crossover fashion (two with rizatriptan 10-mg ODT, one with placebo) after being randomly assigned to one of three treatment sequences (1 : 1 : 1 ratio). The primary endpoint was two-hour pain relief.

RESULTS:

A total of 102 (94%) participants treated at least one study migraine. Pain relief at two hours was significantly greater with rizatriptan compared with placebo (51% vs. 20%, p < .001). Response rates also favored rizatriptan on two-hour pain freedom (22% vs. 12%, p = .013) as well as 24-hour sustained pain relief (38% vs. 14%, p < .001) and sustained pain freedom (20% vs. 11%, p = .036). Treatment was generally well tolerated.

CONCLUSION:

Rizatriptan 10-mg ODT was superior to placebo at providing two-hour pain relief and two-hour pain freedom in the treatment of acute migraine in those who do not respond to sumatriptan 100 mg. Rizatriptan was generally well tolerated in this population.

• Authors: Jeffrey L Seeburger, Frederick R Taylor, Deborah Friedman, Lawrence Newman, Yang Ge, Ying Zhang, Carolyn M Hustad, Jeanne Lasorda, Xiaoyin Fan, David Hewitt, Tony Ho, Kathryn M Connor
• Journal: Cephalalgia : an international journal of headache (Cephalalgia) Vol. 31 Issue 7 Pg. 786-96 (May 2011) ISSN: 1468-2982 [Electronic] England
• PMID: 21078681 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Serotonin Receptor Agonists
• Triazoles
• Tryptamines
• rizatriptan
• Sumatriptan

Topics

• Adult
• Aged
• Cross-Over Studies
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Serotonin Receptor Agonists (therapeutic use)
• Sumatriptan (therapeutic use)
• Treatment Outcome
• Triazoles (therapeutic use)
• Tryptamines (therapeutic use)
• Young Adult