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Predictors of Migraine Headache Recurrence: A Pooled Analysis From the Eletriptan Database

Authors

  • David W. Dodick MD,

    1. From the Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA (Dr. Dodick); Department of Neurology, Albert Einstein College of Medicine, New York, NY, USA (Dr. Lipton); Headache Group, Institute of Neurology, Queen Square, London, UK (Dr. Goadsby); Department of Neurology, Glostrup Hospital, Glostrup, Denmark (Dr. Tfelt-Hansen); Leiden University Medical Centre, Leiden, the Netherlands (Dr. Ferrari); Department of Neurology, University of Duisburg-Essen, Essen, Germany (Dr. Diener); Pfizer Global Pharmaceuticals, New York, NY, USA (Drs. Almas, Albert, and Parsons).
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  • Richard B. Lipton MD,

    1. From the Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA (Dr. Dodick); Department of Neurology, Albert Einstein College of Medicine, New York, NY, USA (Dr. Lipton); Headache Group, Institute of Neurology, Queen Square, London, UK (Dr. Goadsby); Department of Neurology, Glostrup Hospital, Glostrup, Denmark (Dr. Tfelt-Hansen); Leiden University Medical Centre, Leiden, the Netherlands (Dr. Ferrari); Department of Neurology, University of Duisburg-Essen, Essen, Germany (Dr. Diener); Pfizer Global Pharmaceuticals, New York, NY, USA (Drs. Almas, Albert, and Parsons).
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  • Peter J. Goadsby MD, PhD, DSc,

    1. From the Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA (Dr. Dodick); Department of Neurology, Albert Einstein College of Medicine, New York, NY, USA (Dr. Lipton); Headache Group, Institute of Neurology, Queen Square, London, UK (Dr. Goadsby); Department of Neurology, Glostrup Hospital, Glostrup, Denmark (Dr. Tfelt-Hansen); Leiden University Medical Centre, Leiden, the Netherlands (Dr. Ferrari); Department of Neurology, University of Duisburg-Essen, Essen, Germany (Dr. Diener); Pfizer Global Pharmaceuticals, New York, NY, USA (Drs. Almas, Albert, and Parsons).
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  • Peer Tfelt-Hansen MD,

    1. From the Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA (Dr. Dodick); Department of Neurology, Albert Einstein College of Medicine, New York, NY, USA (Dr. Lipton); Headache Group, Institute of Neurology, Queen Square, London, UK (Dr. Goadsby); Department of Neurology, Glostrup Hospital, Glostrup, Denmark (Dr. Tfelt-Hansen); Leiden University Medical Centre, Leiden, the Netherlands (Dr. Ferrari); Department of Neurology, University of Duisburg-Essen, Essen, Germany (Dr. Diener); Pfizer Global Pharmaceuticals, New York, NY, USA (Drs. Almas, Albert, and Parsons).
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  • Michel D. Ferrari MD, PhD,

    1. From the Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA (Dr. Dodick); Department of Neurology, Albert Einstein College of Medicine, New York, NY, USA (Dr. Lipton); Headache Group, Institute of Neurology, Queen Square, London, UK (Dr. Goadsby); Department of Neurology, Glostrup Hospital, Glostrup, Denmark (Dr. Tfelt-Hansen); Leiden University Medical Centre, Leiden, the Netherlands (Dr. Ferrari); Department of Neurology, University of Duisburg-Essen, Essen, Germany (Dr. Diener); Pfizer Global Pharmaceuticals, New York, NY, USA (Drs. Almas, Albert, and Parsons).
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  • Hans-Christoph Diener MD,

    1. From the Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA (Dr. Dodick); Department of Neurology, Albert Einstein College of Medicine, New York, NY, USA (Dr. Lipton); Headache Group, Institute of Neurology, Queen Square, London, UK (Dr. Goadsby); Department of Neurology, Glostrup Hospital, Glostrup, Denmark (Dr. Tfelt-Hansen); Leiden University Medical Centre, Leiden, the Netherlands (Dr. Ferrari); Department of Neurology, University of Duisburg-Essen, Essen, Germany (Dr. Diener); Pfizer Global Pharmaceuticals, New York, NY, USA (Drs. Almas, Albert, and Parsons).
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  • Mary Almas MS,

    1. From the Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA (Dr. Dodick); Department of Neurology, Albert Einstein College of Medicine, New York, NY, USA (Dr. Lipton); Headache Group, Institute of Neurology, Queen Square, London, UK (Dr. Goadsby); Department of Neurology, Glostrup Hospital, Glostrup, Denmark (Dr. Tfelt-Hansen); Leiden University Medical Centre, Leiden, the Netherlands (Dr. Ferrari); Department of Neurology, University of Duisburg-Essen, Essen, Germany (Dr. Diener); Pfizer Global Pharmaceuticals, New York, NY, USA (Drs. Almas, Albert, and Parsons).
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  • Kenneth S. Albert PhD,

    1. From the Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA (Dr. Dodick); Department of Neurology, Albert Einstein College of Medicine, New York, NY, USA (Dr. Lipton); Headache Group, Institute of Neurology, Queen Square, London, UK (Dr. Goadsby); Department of Neurology, Glostrup Hospital, Glostrup, Denmark (Dr. Tfelt-Hansen); Leiden University Medical Centre, Leiden, the Netherlands (Dr. Ferrari); Department of Neurology, University of Duisburg-Essen, Essen, Germany (Dr. Diener); Pfizer Global Pharmaceuticals, New York, NY, USA (Drs. Almas, Albert, and Parsons).
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  • Bruce Parsons MD, PhD

    1. From the Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA (Dr. Dodick); Department of Neurology, Albert Einstein College of Medicine, New York, NY, USA (Dr. Lipton); Headache Group, Institute of Neurology, Queen Square, London, UK (Dr. Goadsby); Department of Neurology, Glostrup Hospital, Glostrup, Denmark (Dr. Tfelt-Hansen); Leiden University Medical Centre, Leiden, the Netherlands (Dr. Ferrari); Department of Neurology, University of Duisburg-Essen, Essen, Germany (Dr. Diener); Pfizer Global Pharmaceuticals, New York, NY, USA (Drs. Almas, Albert, and Parsons).
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Dr. David W. Dodick, Department of Neurology, Mayo Clinic Scottsdale, 13400 East Shea Boulevard, Scottsdale, AZ 85259, USA.

Abstract

Objective.— To identify clinical variables associated with risk of headache recurrence within 22 hours of initial successful treatment of a migraine attack (2-hour headache response), and to analyze the effect of eletriptan in reducing the incidence of recurrence.

Methods.— Data were pooled from 10 randomized, double-blind, placebo-controlled trials evaluating eletriptan 40 mg (E40), eletriptan 80 mg (E80), and sumatriptan 100 mg (S100) for acute migraine treatment. Patients who achieved a headache response (improvement from moderate/severe pain at baseline to mild/no pain at 2 hours postdose) were evaluable. A multivariable logistic regression analysis identified significant predictors of headache recurrence (return to moderate/severe pain intensity within 22 hours of initial headache response). Treatment response was assessed in two high-risk subgroups, defined by the presence of significant recurrence predictors.

Results.— Of 4312 patients responding to acute treatment within 2 hours postdose, 1232 (29%) experienced recurrence. Initial headache response within 2 hours was significantly higher for E40 (62.0%), E80 (67.4%), and S100 (57.9%) compared to placebo (25.1%; all P < .0001). Three clinical variables were significant predictors of recurrence: female gender, age ≥35 years, and severe baseline headache pain. Among patients with all 3 risk factors (n = 742; 17% of total population), recurrence rates were lower with E40 (35.6%) and E80 (32.9%) than placebo (47.8% P < .01). The same result was observed in the subgroup of patients with 2 risk factors (female gender and age ≥35 years; P < .0001 vs placebo). Sustained headache and pain-free response rates (a headache/pain-free response at 2 hours postdose with no headache recurrence and no rescue medication use in the subsequent 22 hours) were significantly higher with E40 and E80 than placebo in both high-risk subgroups (P < .05).

Conclusion.— Female gender, age ≥35 years, and severe baseline headache pain are significant predictors of headache recurrence during a migraine attack. Eletriptan is effective at reducing the incidence of headache recurrence in high-risk subgroups.

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