Rizatriptan Efficacy in ICHD-II Pure Menstrual Migraine and Menstrually Related Migraine

Authors

  • Robert Nett MD,

    1. From the Texas Headache Associates, San Antonio, TX (R. Nett); Headache Associates and ClinExcel Research, Cincinnati, OH (L.K. Mannix); University Headache Center, Stratford, NJ (L. Mueller); Merck & Co. Inc., West Point, PA (A. Rodgers, C.M. Hustad, F. Skobieranda, and K.E. Ramsey).
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  • Lisa K. Mannix MD,

    1. From the Texas Headache Associates, San Antonio, TX (R. Nett); Headache Associates and ClinExcel Research, Cincinnati, OH (L.K. Mannix); University Headache Center, Stratford, NJ (L. Mueller); Merck & Co. Inc., West Point, PA (A. Rodgers, C.M. Hustad, F. Skobieranda, and K.E. Ramsey).
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  • Loretta Mueller DO,

    1. From the Texas Headache Associates, San Antonio, TX (R. Nett); Headache Associates and ClinExcel Research, Cincinnati, OH (L.K. Mannix); University Headache Center, Stratford, NJ (L. Mueller); Merck & Co. Inc., West Point, PA (A. Rodgers, C.M. Hustad, F. Skobieranda, and K.E. Ramsey).
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  • Anthony Rodgers MS,

    1. From the Texas Headache Associates, San Antonio, TX (R. Nett); Headache Associates and ClinExcel Research, Cincinnati, OH (L.K. Mannix); University Headache Center, Stratford, NJ (L. Mueller); Merck & Co. Inc., West Point, PA (A. Rodgers, C.M. Hustad, F. Skobieranda, and K.E. Ramsey).
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  • Carolyn M. Hustad PhD,

    1. From the Texas Headache Associates, San Antonio, TX (R. Nett); Headache Associates and ClinExcel Research, Cincinnati, OH (L.K. Mannix); University Headache Center, Stratford, NJ (L. Mueller); Merck & Co. Inc., West Point, PA (A. Rodgers, C.M. Hustad, F. Skobieranda, and K.E. Ramsey).
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  • Franck Skobieranda MD,

    1. From the Texas Headache Associates, San Antonio, TX (R. Nett); Headache Associates and ClinExcel Research, Cincinnati, OH (L.K. Mannix); University Headache Center, Stratford, NJ (L. Mueller); Merck & Co. Inc., West Point, PA (A. Rodgers, C.M. Hustad, F. Skobieranda, and K.E. Ramsey).
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  • Karen E. Ramsey RPh

    1. From the Texas Headache Associates, San Antonio, TX (R. Nett); Headache Associates and ClinExcel Research, Cincinnati, OH (L.K. Mannix); University Headache Center, Stratford, NJ (L. Mueller); Merck & Co. Inc., West Point, PA (A. Rodgers, C.M. Hustad, F. Skobieranda, and K.E. Ramsey).
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R. Nett, Texas Headache Associates, 19026 Stone Oak Parkway, Suite 210A, San Antonio, TX 78258, USA.

Abstract

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.

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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