Characteristics of Migraine Attacks and Responses to Almotriptan Treatment: A Comparison of Menstrually Related and Nonmenstrually Related Migraines

Authors

  • Merle L. Diamond MD,

    1. From the Diamond Headache Clinic, Chicago, IL, USA (M. Diamond); Headache Care Center, Springfield, MO, USA (R. Cady); Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA (L. Mao, D. Biondi, G. Finlayson, S. Greenberg, and P. Wright).
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  • Roger K. Cady MD,

    1. From the Diamond Headache Clinic, Chicago, IL, USA (M. Diamond); Headache Care Center, Springfield, MO, USA (R. Cady); Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA (L. Mao, D. Biondi, G. Finlayson, S. Greenberg, and P. Wright).
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  • Lian Mao PhD,

    1. From the Diamond Headache Clinic, Chicago, IL, USA (M. Diamond); Headache Care Center, Springfield, MO, USA (R. Cady); Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA (L. Mao, D. Biondi, G. Finlayson, S. Greenberg, and P. Wright).
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  • David M. Biondi DO,

    1. From the Diamond Headache Clinic, Chicago, IL, USA (M. Diamond); Headache Care Center, Springfield, MO, USA (R. Cady); Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA (L. Mao, D. Biondi, G. Finlayson, S. Greenberg, and P. Wright).
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  • Gary Finlayson RPh,

    1. From the Diamond Headache Clinic, Chicago, IL, USA (M. Diamond); Headache Care Center, Springfield, MO, USA (R. Cady); Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA (L. Mao, D. Biondi, G. Finlayson, S. Greenberg, and P. Wright).
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  • Steven J. Greenberg MD,

    1. From the Diamond Headache Clinic, Chicago, IL, USA (M. Diamond); Headache Care Center, Springfield, MO, USA (R. Cady); Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA (L. Mao, D. Biondi, G. Finlayson, S. Greenberg, and P. Wright).
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  • Pamela Wright RN

    1. From the Diamond Headache Clinic, Chicago, IL, USA (M. Diamond); Headache Care Center, Springfield, MO, USA (R. Cady); Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA (L. Mao, D. Biondi, G. Finlayson, S. Greenberg, and P. Wright).
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  • Conflict of Interest: Merle L Diamond, MD, is a consultant for GSK, Merck, Ortho-McNeil, and Primary Care Network; advisory board member for AstraZeneca, GSK, Ortho-McNeil, and Primary Care Network; speakers bureau member for AstraZeneca, GSK, Merck, Ortho-McNeil, Pfizer, and Primary Care Network; received research grants from AstraZeneca, GSK, Merck, Ortho-McNeil.
    Roger K. Cady, MD, is a consultant for Aradigm Corp, GSK, Jazz Pharmaceutical and Ortho-McNeil; advisory board member for Allergan, Atrix Labs, Capnia, Endo, GSK, Johnson & Johnson, Medpointe, Merck, Ortho-McNeil, and Winston Labs; received research grants from Abbott, AdvanceBionics, Alizyme, Allergan, Alexza, Aradigm Corp, Capnia, Cipher, Eisai, Endo, GelStat, GSK, Jazz Pharmaceutical, Johnson & Johnson, MAP Pharmaceutical, Matrixx, Merck, Neuralieve, Novartis, Ortho-McNeil, Pfizer, Pozen, Schwartz, Torrey Pines, and Vernalis.
    Lian Mao, PhD; David M Biondi, DO; Gary Finlayson, RPh; Steven J Greenberg, MD; Pamela Wright, RN are employees of Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NewJersey.

M. Diamond, The Diamond Headache Clinic, LTD., 467 West Deming Place, Chicago, IL 60614, USA.

Abstract

Objectives.— To compare the clinical characteristics of menstrually related migraines (MRMs) and nonmenstrually related migraines (nonMRMs) and to investigate the efficacy of almotriptan in the treatment of these migraine subtypes.

Design/Methods.— These are post hoc analyses of data from the AXERT® Early miGraine Intervention Study (AEGIS), a multicenter, double-blind, parallel-group trial that evaluated adults with IHS-defined migraine with and without aura. Patients were randomized 1 : 1 to treat 3 consecutive headaches with almotriptan 12.5 mg or matching placebo at the first sign of headache typical of their usual migraine, at any level of pain intensity but within 1 hour of onset. MRMs were defined as those occurring ±2 days of the first day of menstrual flow. Post hoc analyses to describe headache characteristics pooled all migraine attacks experienced by patients who reported ≥1 menses during the study regardless of assigned treatment group. The post hoc efficacy analyses included outcomes of almotriptan treatment compared with placebo treatment for all migraines in patients with a menstrual record.

Results.— Of the 275 women in the AEGIS intent-to-treat population, 190 (69.1%; 97 almotriptan, 93 placebo; aged 18-54 years) reported ≥1 menses during the trial. Of the 506 migraines reported by these patients, 95 (18.8%) occurred ±2 days of the first day of menstrual flow and were defined as MRM. Aura was associated with 11.7% of MRM and 15.0% of nonMRM. Allodynia-associated symptoms were present with 62.8% of MRM and 57.0% of nonMRM. Prior to treatment, 19.1% of MRM were associated with normal functional ability, 68.1% with disturbed functional ability, and 12.8% required bed rest compared with 18.9%, 68.8%, and 12.3%, respectively, of nonMRM. Pretreatment pain intensity was mild in 40.0%, moderate in 47.4%, and severe in 12.6% of MRM compared with 43.6%, 47.2%, and 9.2%, respectively, of nonMRM. Almotriptan treatment efficacy outcomes for MRM vs nonMRM, respectively, were: 2-hour pain relief, 77.4% vs 68.3%; 2-hour pain free, 35.4% vs 35.9%; and sustained pain free, 22.9% vs 23.8%. Almotriptan was similarly effective in relieving migraine-associated symptoms and improving functional disability associated with both MRM and nonMRM.

Conclusions.— Prior to treatment, the presence of migraine-associated characteristics including aura, allodynia-associated symptoms, photophobia, phonophobia, and nausea were similar for both MRM and nonMRM attacks. The pretreatment levels of pain intensity and functional disability were likewise similar across the migraine subtypes. Almotriptan was equally effective in the treatment of both MRM and nonMRM attacks and was associated with an adverse event profile that was similar to placebo treatment.

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