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Ann Neurol. 2015 Dec;78(6):970-81. doi: 10.1002/ana.24534. Epub 2015 Nov 13.

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

Author information

  • 1Department of Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA.
  • 2Department of Neurology, Rambam Health Care Campus, and Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
  • 3Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA.
  • 4Department of Epidemiology, Harvard School of Public Health, Department of Medicine, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01225263.

PMID:
26418341
PMCID:
PMC4715556
DOI:
10.1002/ana.24534
[PubMed - indexed for MEDLINE]
Free PMC Article
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