Results of a recent study have shown that simvastatin (Zocor) plus vitamin D is effective for the prevention of headache in adults with episodic migraine. Given statins’ ability to repair endothelial dysfunction, this approach may also reduce the increased risk for vascular diseases among migraineurs, said Richard B. Lipton, MD, FAAN, Director, Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, NY, at the 2016 American Academy of Neurology annual meeting. Dr Lipton did not partake in the study, but discussed the study results during a plenary session.
“For weeks 1 to 12, there was an 8-day reduction per 4-week period for the group receiving active treatment. When we looked at weeks 13 to 24, the magnitude of the reduction in headache days was maintained,” said Dr Lipton.
There is biological evidence that migraine is associated with endothelial dysfunction, which simvastatin plus vitamin D is intended to target, Dr Lipton said. The results of the study were published late last year (Buettner C, et al. Ann Neurol. 2015;78:970-981).
In this randomized, double-blind, placebo-controlled clinical trial with a 12-week baseline period and a 24-week intervention period, the researchers randomly assigned 57 adults with episodic migraine to simvastatin 20-mg tablets twice daily plus vitamin D3 1000 international units capsules twice daily or to a matching placebo combination.
Participants who received simvastatin plus vitamin D3 had a greater decrease in the number of migraine days from baseline to intervention weeks 1 to 12 compared with patients who received placebo. Overall, the researchers found a change of –8 days of migraine in the active treatment group compared with 1 more day of migraine in the placebo group.
Furthermore, this reduction was maintained during intervention weeks 13 to 24, with a change of –9 days of migraine in the active treatment group versus +3 days of migraine in the placebo group.
In addition, in the active treatment group, 8 (25%) patients had a 50% reduction in the number of migraine days at 12 weeks, and the same was true for 9 (29%) patients at 24 weeks after randomization. Conversely, only 1 (3%) patient in the placebo group had a 50% reduction in the number of migraine days.
Adverse events were similar in the active treatment group and the placebo group, the researchers noted.
Although optimistic regarding this regimen’s potential, Dr Lipton was quick to temper expectations.
“There has only been one randomized trial, which is modest in size. Nevertheless, this treatment is quite safe, and headache specialists are now using it in practice,” he said.