Abstract | OBJECTIVE: BACKGROUND: In 2004, the International Headache Society proposed new research criteria for menstrual migraine (International Classification of Headache Disorders [ICHD-II]). Two subtypes were defined: PMM, in which attacks occur exclusively with menstruation, and menstrually related migraine (MRM), in which attacks may also occur at other times of the cycle. METHODS: The 2 protocols (MM1 and MM2) were identical randomized, double-blind studies. Adult patients with ICHD-II menstrual migraine were assigned to either rizatriptan 10-mg tablet or placebo (2:1). Patients were to treat a single menstrual migraine attack of moderate or severe pain intensity. This prospectively planned substudy pooled data from patients with a diagnosis of PMM from both studies. The primary substudy endpoint was 2-hour pain relief. Efficacy data were summarized for patients with a diagnosis of MRM. RESULTS: Of 707 (MM1: 357, MM2: 350) patients treated in the study, 146 patients (MM1: 81, MM2: 65) had a diagnosis of PMM. The percentage of patients reporting 2-hour pain relief was significantly greater for rizatriptan than for placebo for both PMM (73% vs 50%, P = .006) and MRM subgroups (71% vs 52%, P < .001). Most other efficacy endpoints favored rizatriptan compared with placebo in patients with either PMM or MRM. CONCLUSION:
Rizatriptan 10 mg was superior to placebo for the treatment of PMM, as measured by 2-hour pain relief. Rizatriptan was also effective for the treatment of MRM and for relief of migraine-associated symptoms for both headache subtypes.
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Authors | Robert Nett, Lisa K Mannix, Loretta Mueller, Anthony Rodgers, Carolyn M Hustad, Franck Skobieranda, Karen E Ramsey |
Journal | Headache
(Headache)
Vol. 48
Issue 8
Pg. 1194-201
(Sep 2008)
ISSN: 1526-4610 [Electronic] United States |
PMID | 18422606
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Serotonin Receptor Agonists
- Triazoles
- Tryptamines
- rizatriptan
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Topics |
- Adolescent
- Adult
- Clinical Protocols
- Disability Evaluation
- Double-Blind Method
- Female
- Humans
- Menstruation Disturbances
(complications, drug therapy)
- Migraine Disorders
(drug therapy, etiology)
- Pain Measurement
- Prospective Studies
- Retrospective Studies
- Serotonin Receptor Agonists
(therapeutic use)
- Treatment Outcome
- Triazoles
(therapeutic use)
- Tryptamines
(therapeutic use)
- Young Adult
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