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Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial
Author(s) -
Buettner Catherine,
Nir RonyReuven,
Bertisch Suzanne M.,
Bernstein Carolyn,
Schain Aaron,
Mittleman Murray A.,
Burstein Rami
Publication year - 2015
Publication title -
annals of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.764
H-Index - 296
eISSN - 1531-8249
pISSN - 0364-5134
DOI - 10.1002/ana.24534
Subject(s) - medicine , simvastatin , placebo , migraine , tolerability , interquartile range , adverse effect , randomized controlled trial , alternative medicine , pathology
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