Rizatriptan efficacy in ICHD-II pure menstrual migraine and menstrually related migraine.
OBJECTIVE
To examine the efficacy of rizatriptan for the treatment of pure menstrual migraine (PMM).


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.


CONCLUSIONS
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.
Nett
Robert
R
Texas Headache Associates, San Antonio, TX 78258, USA.
Mannix
Lisa K
LK
Mueller
Loretta
L
Rodgers
Anthony
A
Hustad
Carolyn M
CM
Skobieranda
Franck
F
Ramsey
Karen E
KE
D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008599:Menstruation Disturbances / Q000150:complications / Q000188:drug therapy*; D008881:Migraine Disorders / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D011446:Prospective Studies; D012189:Retrospective Studies; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use*; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use*; D014363:Tryptamines / Q000627:therapeutic use*; D055815:Young Adult
D017366:Serotonin Receptor Agonists; D014230:Triazoles; D014363:Tryptamines; C093622:rizatriptan