Adding atorvastatin to treatment with sodium valproate may reduce the number of acute migraine attacks and pain severity in patients with migraine with aura, according to study results published in Journal of Pharmaceutical Health Care and Sciences.
Migraine is a common cause for headache and has a significant negative impact on daily activities of the patients. However, treatment options are limited to headache relief or reducing the frequency and severity of attacks. As statins may improve vasomotor and vascular function, study researchers hypothesized that this treatment may prevent migraine headache.
The objective of the current study was to explore the potential benefit of adding atorvastatin to sodium valproate in the prevention of migraine attacks in patients with migraine with aura.
The prospective, randomized, triple-blind placebo-controlled trial compared atorvastatin with placebo in prevention of migraine attacks after correction with vitamin D supplementation in patients with vitamin D3 deficiency.
The study included 68 patients with migraine with aura randomly assigned to receive atorvastatin 20 mg with sodium valproate 500 mg (median age, 37.2 years; 66.6% women), or placebo with sodium valproate (median age, 36.4 years; 67.7% women), given once a day for 2 months. Study researchers evaluated the frequency and severity of migraine attacks before and after treatment.
During 8 weeks of treatment, the mean score of pain severity on visual analog scale was 5.87 in placebo group and 3.27 in intervention group (P =.0001). Treatment with atorvastatin also reduced the frequency of migraine attacks, compared with placebo (P =.0001). The average scores of migraine attacks in atorvastatin group were 1.61, compared with 3.61 in the placebo group.
There were no differences between the groups regarding potential side effects. The most common adverse effects included gastrointestinal symptoms, joint or skeletal pain, myalgia, and skin rash or itching.
Patient satisfaction with their medications was significantly higher among participants in atorvastatin group, compared with those in placebo group (90.9% vs 51.6%, respectively) and the difference between the groups remained significant after controlling for various confounders (odds ratio, 9.83; P =.001).
The study had several limitations, including lack of therapeutically monitoring of serum levels of valproic acid, small number of patients, and limited number of adverse effects.
“Adding atorvastatin to migraine with aura preventive regimen may help reduce the number of acute attacks and pain severity without causing considerable side effects and led to a better patient satisfaction,” concluded the study researchers.
Ganji R, Majdinasab N, Hesam S, Rostami N, Sayyah M, Sahebnasagh A. Does atorvastatin have augmentative effects with sodium valproate in prevention of migraine with aura attacks? A triple-blind controlled clinical trial. J Pharm Health Care Sci. 20211;7(1):12. doi:10.1186/s40780-021-00198-8