Prophylactic Etoricoxib Is Effective in Preventing “First of Ramadan” Headache: A Placebo-Controlled Double-Blind and Randomized Trial of Prophylactic Etoricoxib for Ritual Fasting Headache

Authors

  • Michael J. Drescher MD, FACEP,

    Corresponding author
    1. From Division of Emergency Medicine, Hartford Hospital/University of Connecticut, Hartford, CT, USA (M.J. Drescher); Department of Emergency Medicine, Shaare Zedek Medical Center, Jerusalem, Israel (Z. Wimpfheimer); Department of Internal Medicine, Shaare Zedek Medical Center, Jerusalem, Israel (S. Abu Khalef); Center for Scientific Affairs, Merck and Co., North Wales, PA, USA (A. Gammaitoni); Department of Pediatrics, Rambam Medical Center, Haifa, Israel (N. Shehadeh); Medical Department, MSD, Petah Tikvah, Israel (R. Torgovicky).
      M.J. Drescher, Division of Emergency Medicine, Hartford Hospital, 80 Seymour Street, Hartford, CT 06119, USA, email: mdresch@harthosp.org
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  • Zev Wimpfheimer MD, FACEP,

    1. From Division of Emergency Medicine, Hartford Hospital/University of Connecticut, Hartford, CT, USA (M.J. Drescher); Department of Emergency Medicine, Shaare Zedek Medical Center, Jerusalem, Israel (Z. Wimpfheimer); Department of Internal Medicine, Shaare Zedek Medical Center, Jerusalem, Israel (S. Abu Khalef); Center for Scientific Affairs, Merck and Co., North Wales, PA, USA (A. Gammaitoni); Department of Pediatrics, Rambam Medical Center, Haifa, Israel (N. Shehadeh); Medical Department, MSD, Petah Tikvah, Israel (R. Torgovicky).
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  • Samer Abu Khalef MD,

    1. From Division of Emergency Medicine, Hartford Hospital/University of Connecticut, Hartford, CT, USA (M.J. Drescher); Department of Emergency Medicine, Shaare Zedek Medical Center, Jerusalem, Israel (Z. Wimpfheimer); Department of Internal Medicine, Shaare Zedek Medical Center, Jerusalem, Israel (S. Abu Khalef); Center for Scientific Affairs, Merck and Co., North Wales, PA, USA (A. Gammaitoni); Department of Pediatrics, Rambam Medical Center, Haifa, Israel (N. Shehadeh); Medical Department, MSD, Petah Tikvah, Israel (R. Torgovicky).
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  • Arnold Gammaitoni PharmD,

    1. From Division of Emergency Medicine, Hartford Hospital/University of Connecticut, Hartford, CT, USA (M.J. Drescher); Department of Emergency Medicine, Shaare Zedek Medical Center, Jerusalem, Israel (Z. Wimpfheimer); Department of Internal Medicine, Shaare Zedek Medical Center, Jerusalem, Israel (S. Abu Khalef); Center for Scientific Affairs, Merck and Co., North Wales, PA, USA (A. Gammaitoni); Department of Pediatrics, Rambam Medical Center, Haifa, Israel (N. Shehadeh); Medical Department, MSD, Petah Tikvah, Israel (R. Torgovicky).
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  • Naim Shehadeh MD,

    1. From Division of Emergency Medicine, Hartford Hospital/University of Connecticut, Hartford, CT, USA (M.J. Drescher); Department of Emergency Medicine, Shaare Zedek Medical Center, Jerusalem, Israel (Z. Wimpfheimer); Department of Internal Medicine, Shaare Zedek Medical Center, Jerusalem, Israel (S. Abu Khalef); Center for Scientific Affairs, Merck and Co., North Wales, PA, USA (A. Gammaitoni); Department of Pediatrics, Rambam Medical Center, Haifa, Israel (N. Shehadeh); Medical Department, MSD, Petah Tikvah, Israel (R. Torgovicky).
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  • Rafael Torgovicky MD, MHA

    1. From Division of Emergency Medicine, Hartford Hospital/University of Connecticut, Hartford, CT, USA (M.J. Drescher); Department of Emergency Medicine, Shaare Zedek Medical Center, Jerusalem, Israel (Z. Wimpfheimer); Department of Internal Medicine, Shaare Zedek Medical Center, Jerusalem, Israel (S. Abu Khalef); Center for Scientific Affairs, Merck and Co., North Wales, PA, USA (A. Gammaitoni); Department of Pediatrics, Rambam Medical Center, Haifa, Israel (N. Shehadeh); Medical Department, MSD, Petah Tikvah, Israel (R. Torgovicky).
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  • This research was supported by investigator initiated grant number ARX_ISP_IL1001 from MSD Israel. NCT number is NCT01148303.

  • Conflict of Interest: M. J. D. and Z. W. have grant support from MSD (Merck) Israel for the submitted work. A. G. and R. T. are employees of Merck and Co. that might have an interest in the submitted work. We are aware of no other factors which would cause a conflict of interest.

M.J. Drescher, Division of Emergency Medicine, Hartford Hospital, 80 Seymour Street, Hartford, CT 06119, USA, email: mdresch@harthosp.org

Abstract

Background.— Religious fasting is associated with headache. This has been documented as “Yom Kippur headache” and “first of Ramadan headache.” Etoricoxib, a Cox-2 inhibitor with a 22-hour half-life, has been shown effective in preventing fasting headache when taken just prior to the 25-hour Yom Kippur fast. We hypothesized that etoricoxib would also be effective in preventing headache during Ramadan, despite the different characteristics of the fast.

Methods.— We performed a double-blind randomized prospective crossover trial of etoricoxib 90 mg vs placebo, taken just prior to the onset of fasting, during the first 2 weeks of Ramadan 2010. Healthy adults aged 18-65 years were enrolled. Demographics, headache history and a daily post-fast survey were collected. We compared incidence, time of onset, and intensity of headache on each day and side effects in control and treatment groups.

Results.— We enrolled 222 patients and 189 completed the post-fast questionnaire (87%). Etoricoxib reduced the incidence of “first of Ramadan” headache by 54% (46% in placebo group [n = 92] vs 21% [n = 96] in etoricoxib group) (P < .0001, OR 3.19 [95% CI 1.68-6.06]). For days 1-6, the mean number of headache days for the placebo group was 1.60 (n = 92) and for the treatment group the mean was 0.86 (n = 99) headache days (P = .003). Median severity of headache in the treatment group was significantly lower. In the second week, there was no significant difference in incidence of headache between groups, and the incidence of headache in the placebo group dropped markedly over time.

Conclusion.— Etoricoxib 90 mg taken prior to a 15-hour ritual fast decreases incidence of and attenuates headache during the first 5 days of the month of Ramadan.

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