Efficacy and safety of intensive statin therapy in Chinese patients with atherosclerotic intracranial arterial stenosis: a single-center, randomized, single-blind, parallel-group study with one-year follow-up.

ABSTRACT

OBJECTIVES: The purpose of this study is to validate the efficacy of intensive statin therapy for patients with atherosclerotic intracranial arterial stenosis (AICAS). METHODS: In this study, we performed a single-center, randomized, single-blind, parallel-group clinical trial. A total of 120 Chinese patients with AICAS were enrolled and randomly divided into three groups [low-dose atorvastatin therapy (LAT, 10mg/day), standard-dose atorvastatin therapy (SAT, 20mg/day), and intensive-dose atorvastatin therapy (IAT, 40mg/day) groups] in a 111 ratio. Evaluation variables, including changes in serum lipid profiles, degree of stenosis, and perfusion-related parameters derived from computed tomography perfusion (CTP) imaging from baseline to weeks 26 and 52, as well as the occurrence of cerebrovascular events during the study period, were used to compare the benefits of these three statin therapies. RESULTS: After 52 weeks of treatment, improvement of serum lipid profiles, degree of stenosis, and perfusion-related parameters were all significantly better in the IAT group. In addition, the cumulative probability of cerebrovascular events at 52 weeks was significantly lower in the IAT group than in the LAT group, although there was no statistical difference between the IAT group and the SAT group. The proportion of patients experiencing any adverse event was similar among the three treatment groups. Adverse events caused by IAT were generally mild; no serious adverse events occurred throughout the entire period of study. CONCLUSION: In conclusion, long-term use of IAT appears to be a safe and effective treatment at least for Chinese patients with AICAS.