Safety of high-dose atorvast atin in Chinese patients:a Meta-analysisLI Xuan, CHEN / 中国介入心脏病学杂志

ABSTRACT

Objective To systematically evaluate the safety of high dose atorvastatin (80 mg daily) in Chinese patients. Methods Randomized controlled trials (RCTs) investigating 80 mg/ d atorvastatin vs. low-dose atorvastatin or placebo or blank were electionically retrieved in date bases of EMbase, PubMed, the Cochrane Library, WanFang, CNKI and WeiPu. Meta-analysis was performed using RevMan 5. 2 and Stata 11. 0 software. Results A total of 20 RCTs involving 2282 cases were included. The results of meta-analysis showed no significant differences betweent the 80 mg/ d atorvastatin group and the control group in the incidence of gastrointestinal adverse events (RR 1. 53, 95% CI 0. 85-2. 76, P = 0. 16), hepatic adverse events (RR 1. 53, 95% CI 0. 99 - 2. 36, P = 0. 05), muscular adverse events (RR 1. 51, 95% CI 0. 92 -2. 49, P = 0. 10), serious hepatic injuries ( RR 2. 33,95% CI 0. 88 - 6. 20, P = 0. 09) and serious muscular myopathies (RR 1. 40, 95% CI 0. 46 - 4. 30, P = 0. 56). Subgroup analysis by type of cotrast media used and durations of taking 80 mg/ d atorvastatin showed there were higher risks of gastrointestinal adverse events in the 80 mg/ d group when compared to blank control ( RR 4. 22, 95% CI 1. 11 - 16. 04, P = 0. 03). Conclusions The current evidence shows that 80 mg / d atorvastatin may be relatively safe in terms of adverse events in gastrointestinal tract, liver and muscular system, and relatively has risk in causing severe liver injuries and myopathies. With limited quantity and quality from the RCTs available, more high quality RCTs are needed to verify the above conclusion.