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A Randomized Double-Blind Study Comparing Rizatriptan, Dexamethasone, and the Combination of Both in the Acute Treatment of Menstrually Related Migraine

Authors

  • Marcelo Bigal MD, PhD,

    1. From the Merck Research Laboratories, Whitehouse Station, NJ, USA (M. Bigal and T. Ho); The New England Center for Headache, Stamford, CT, USA (F. Sheftell) Center for Headache and Pain, Neurological Institute, Cleveland Clinic Foundation, Cleveland, OH, USA (D. Tepper, and S. Tepper); University of California in Los Angeles—Neurology, Los Angeles, CA, USA (A. Rapoport). [Correction added after online publication 14-Apr-2008: Authors' name and affiliations updated.]
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  • Fred Sheftell MD,

    1. From the Merck Research Laboratories, Whitehouse Station, NJ, USA (M. Bigal and T. Ho); The New England Center for Headache, Stamford, CT, USA (F. Sheftell) Center for Headache and Pain, Neurological Institute, Cleveland Clinic Foundation, Cleveland, OH, USA (D. Tepper, and S. Tepper); University of California in Los Angeles—Neurology, Los Angeles, CA, USA (A. Rapoport). [Correction added after online publication 14-Apr-2008: Authors' name and affiliations updated.]
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  • Stewart Tepper MD,

    1. From the Merck Research Laboratories, Whitehouse Station, NJ, USA (M. Bigal and T. Ho); The New England Center for Headache, Stamford, CT, USA (F. Sheftell) Center for Headache and Pain, Neurological Institute, Cleveland Clinic Foundation, Cleveland, OH, USA (D. Tepper, and S. Tepper); University of California in Los Angeles—Neurology, Los Angeles, CA, USA (A. Rapoport). [Correction added after online publication 14-Apr-2008: Authors' name and affiliations updated.]
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  • Deborah Tepper MD,

    1. From the Merck Research Laboratories, Whitehouse Station, NJ, USA (M. Bigal and T. Ho); The New England Center for Headache, Stamford, CT, USA (F. Sheftell) Center for Headache and Pain, Neurological Institute, Cleveland Clinic Foundation, Cleveland, OH, USA (D. Tepper, and S. Tepper); University of California in Los Angeles—Neurology, Los Angeles, CA, USA (A. Rapoport). [Correction added after online publication 14-Apr-2008: Authors' name and affiliations updated.]
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  • Tony W. Ho MD,

    1. From the Merck Research Laboratories, Whitehouse Station, NJ, USA (M. Bigal and T. Ho); The New England Center for Headache, Stamford, CT, USA (F. Sheftell) Center for Headache and Pain, Neurological Institute, Cleveland Clinic Foundation, Cleveland, OH, USA (D. Tepper, and S. Tepper); University of California in Los Angeles—Neurology, Los Angeles, CA, USA (A. Rapoport). [Correction added after online publication 14-Apr-2008: Authors' name and affiliations updated.]
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  • Alan Rapoport MD

    1. From the Merck Research Laboratories, Whitehouse Station, NJ, USA (M. Bigal and T. Ho); The New England Center for Headache, Stamford, CT, USA (F. Sheftell) Center for Headache and Pain, Neurological Institute, Cleveland Clinic Foundation, Cleveland, OH, USA (D. Tepper, and S. Tepper); University of California in Los Angeles—Neurology, Los Angeles, CA, USA (A. Rapoport). [Correction added after online publication 14-Apr-2008: Authors' name and affiliations updated.]
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  • Conflict of Interest: This study was sponsored by an Investigator Initiated Study Grant from Merck Inc. The authors received research support and are/were in the speaker bureau of Merck. Drs. Bigal and Ho are full-time employees of Merck Research Laboratories.

Marcelo E. Bigal, MD, PhD, Global Director, Scientific Affairs, Neuroscience, One Merck Drive, P.O. Box 100, Whitehouse Station, NJ 08889-0100, USA.

Abstract

Objectives.— To assess the efficacy and tolerability of rizatriptan (RI), dexamethasone (DE), and RI combined with DE (RI+DE) in the acute treatment of menstrually related migraine (MRM).

Methods.— This was a randomized, double-blind, 6-attack crossover study comparing RI 10 mg, DE 4 mg, and RI+DE (2 attacks each). The primary endpoint was 24-hour sustained-relief. The secondary endpoint was 24-hour sustained pain-free. We treated the primary and secondary endpoint as dichotomous outcomes and used matched nonparametric statistics to assess proportions. We used logistic regression to determine the effect of treatment order and if response to previous treatment influenced treatment response.

Results.— A total of 35 patients treated 190 attacks (mean of 5.4 per participant). For the primary endpoint, RI was significantly superior to DE (62.7% vs 33.3%, P = .001). RI+DE was superior to RI (81.5% vs 62.7%, P < .05) and to DE (81.5% vs 33.3%%, P < .001). For the secondary endpoint RI was also superior to DE (32.2% vs 12.1%, P < .05). RI+DE was superior to RI (50.7% vs 32.2%, P < .05) and DE (P < .01, RR). Similar findings were seen for the other endpoints. More attacks treated with DE+RI (33.8%) were associated with side effects, compared to RI (18.6%) and DE (15.2%).

Conclusions.— Rizatriptan is an effective treatment for MRM. RI+DE is significantly more effective than RI alone, although is associated with higher rate of adverse events. The combination should be considered for subjects with high disability, incomplete relief, or recurrence of pain with triptan monotherapy. The use of DE alone in the treatment of MRM is not justified based on our data.

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