Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial

Authors

  • Catherine Buettner MD, MPH,

    Corresponding author
    1. Department of Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA
    • Address correspondence to Dr Catherine Buettner, Department of Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Shapiro 1, Boston, MA 02215. E-mail: cbuettne@bidmc.harvard.edu

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  • Rony-Reuven Nir MD, PhD,

    1. Department of Neurology, Rambam Health Care Campus, and Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel
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  • Suzanne M. Bertisch MD, MPH,

    1. Department of Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA
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  • Carolyn Bernstein MD,

    1. Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA
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  • Aaron Schain PhD,

    1. Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA
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  • Murray A. Mittleman MD, DrPH,

    1. Department of Epidemiology, Harvard School of Public Health, Department of Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA
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  • Rami Burstein PhD

    1. Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA
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Abstract

Objective

The aim of this work was to assess efficacy and tolerability of simvastatin plus vitamin D for migraine prevention in adults with episodic migraine.

Methods

We performed a randomized, double-blind, placebo-controlled trial with a 12-week baseline period and 24-week intervention period in 57 adults with episodic migraine. Participants were randomly assigned to simvastatin 20 mg tablets twice-daily plus vitamin D3 1,000 international units capsules twice-daily or matching placebo tablets and capsules.

Results

Compared to placebo, participants using simvastatin plus vitamin D3 demonstrated a greater decrease in number of migraine days from the baseline period to intervention weeks 1 to 12: a change of –8.0 (interquartile range [IQR]: −15.0 to −2.0) days in the active treatment group versus +1.0 (IQR: −1.0 to + 6.0) days in the placebo group, p < 0.001; and to intervention weeks 13 to 24: a change of −9.0 (IQR: −13 to −5) days in the active group versus +3.0 (IQR: −1.0 to + 5.0) days in the placebo group, p < 0.001. In the active treatment group, 8 patients (25%) experienced 50% reduction in the number of migraine days at 12 weeks and 9 (29%) at 24 weeks postrandomization. In comparison, only 1 patient (3%) in the placebo group (p = 0.03) experienced such a reduction. Adverse events were similar in both active treatment and placebo groups.

Interpretation

The results demonstrate that simvastatin plus vitamin D is effective for prevention of headache in adults with episodic migraine. Given statins' ability to repair endothelial dysfunction, this economical approach may also reduce the increased risk for vascular diseases among migraineurs. Ann Neurol 2015;78:970–981

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