Pain-free efficacy after treatment with sumatriptan in the mild pain phase of menstrually associated migraine

doi:10.1016/S0029-7844(03)00659-8

Obstetrics & Gynecology

Volume 102, Issue 4, October 2003, Pages 835-842

The results of this trial were presented in part at the 2002 Diamond Headache Update in Orlando, FL, July 16–20, 2002. Abstract was presented at the American Academy of Neurology Meeting, March 29–April 5, 2003.

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Abstract

Objective

To estimate the efficacy of sumatriptan 50-mg and 100-mg tablets in menstrually associated migraine when treatment is administered during the mild pain phase.

Methods

A randomized, double-blind, placebo-controlled, single-attack study was conducted. Menstrually associated migraine was defined as any migraine beginning on or between day −2 and day 4, with day 1 = first day of flow. Patients had at least a 1-year history of migraine as defined by International Headache Society criteria and reported regularly occurring menstrually associated migraines typically having a mild pain phase. Patients treated attacks within 1 hour of the onset of pain but only if the pain was mild at onset and while the pain was still mild.

Results

In the 349 women with menstrually associated migraine, sumatriptan was significantly more effective than placebo: 61% and 51% of patients who used sumatriptan 100 mg and 50 mg, respectively, were pain-free 2 hours after treatment compared with 29% of patients who used placebo (P < .001 for both comparisons). At 2 hours, 51% and 45% of patients who used sumatriptan 100 mg and 50 mg were free of pain and associated symptoms (photophobia, phonophobia, nausea, vomiting) compared with 25% of placebo patients (P < .001 for both comparisons). Adverse events were low for sumatriptan 100 and 50 mg, and both doses were generally well tolerated.

Conclusion

Sumatriptan 50-mg and 100-mg tablets are generally well tolerated and effective in providing pain-free relief and relief of the associated symptoms of menstrually associated migraine when administered in the mild pain phase.

Section snippets

Patients and methods

Women aged 18–65 years were eligible for participation in this study. They were required to have a minimum 1-year history of migraine with or without aura as defined by International Headache Society criteria, the ability to distinguish between migraine attacks and other types of headaches, and a minimum 6-month history of regularly occurring menstrually associated migraines. Menstrually associated migraine was defined as any patient-identified migraine beginning on day −2 through day 4, with

Results

The disposition of subjects and composition of populations for statistical analysis is shown in Figure 1. Unless otherwise noted, the reference population is the menstrually associated migraine population because this group was predetermined for analysis of efficacy. Only 19 of 368 patients in the intent-to-treat population were excluded from the menstrually associated migraine population, with the result that the data are very similar for these populations (Figure 1). The menstrually

Discussion

The results of this prospective study indicate that sumatriptan 50 mg and 100 mg effectively treat menstrually associated migraine when treatment is administered during the mild pain phase, and pain-free relief at 2 hours is the criterion for treatment success. Results of this study suggest that sumatriptan 100 mg may be more efficacious than 50 mg when used in the early treatment paradigm. Because this study was not powered to detect statistical differences between active doses, further

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Original researchPain-free efficacy after treatment with sumatriptan in the mild pain phase of menstrually associated migraine

Abstract

Objective

Methods

Results

Conclusion

Section snippets

Patients and methods

Results

Discussion

Neurol Clin

Clin Ther

Migraine diagnosis and treatmentResults from the American Migraine Study II

Headache

Menstrual migrainesEtiology, treatment, and relationship to premenstrual syndrome

Curr Opin Obstet Gynecol

“Menstrual” migraineTowards a definition

Cephalalgia

Relationship of headache to phase of the menstrual cycle among young womenA daily diary study

Neurology

Menstrual cycle and headache in a population sample of migraineurs

Neurology

Sumatriptan is effective in the treatment of menstrual migraine

Cephalalgia

Original research
Pain-free efficacy after treatment with sumatriptan in the mild pain phase of menstrually associated migraine