Preliminary results of pravastatin on non-hemorrhagic vertebral artery dissection: an exploratory randomized and...

BACKGROUND: There is limited information about the pleiotropic effects of statin on cerebrovascular diseases. The authors aimed to investigate the effect of pravastatin on non-hemorrhagic vertebral artery dissection (VAD) in a clinical setting. METHODS: An exploratory randomized and controlled study was designed for the non-hemorrhage VAD (CRIS, KCT00035970). Primary outcomes were 1- and 6-month radiologic changes on vessel wall magnetic resonance imaging (VW-MRI), with secondary outcomes related to the clinical and laboratory parameters, and safety outcomes of the pravastatin use. RESULTS: Finally, 23 patients were enrolled, consisting of 12 in the pravastatin group and 11 in the control with similar baseline characteristics except the age (55.0 versus 45.5 years, P = .01). Morphologic changes in the early period (0–1 month) were more improved or resolved in the pravastatin group with a borderline significance (crude odds ratio: 7.500 [95% confidence interval: 0.921-64.047], P = .06). However, age-adjusted analysis showed no difference in morphologic changes between the groups (adjusted odds ratio: 0.853 [95% confidence interval: 0.033-22.020], P = .92). The serum level of high-sensitivity C-reactive protein (hs-CRP) in the pravastatin group showed a descending tendency in the early period (Z-score: -1.843, P = .07), whereas it significantly increased in the control (Z-score: -2.371, P = .02). There were no safety issues at all. CONCLUSION: Pravastatin had a borderline significant effect on the recovery of non-hemorrhage VAD with no additional adverse effects. A further study with a larger scale is expected to make more concrete evidences about the pleiotropic effects of statin on the non-hemorrhagic VAD. TRIAL REGISTRATION: The present study registered in a clinical research information service approved by World Health Organization (CRIS, KCT00035970, Registered on 7 March 2019; available at: https://cris.nih.go.kr/cris/search/detailSearch.do?seq=25234%26status=5%26seq_group=12949%26search_page=M ).