Аннотация:This study aimed to evaluate Atorvastatin (ATO)-associated hepatotoxicity using prescription sequence symmetry analysis (PSSA), based on a health insurance database of a Chinese population living in Jiangsu Province, China.Patients prescribed ATO and hepatoprotective drugs in 2017 were identified, and the run-in period was determined based on the "waiting-time" distribution. Adjusted sequence ratio (ASR) and 95% confidence interval (95% CI) were calculated to estimate the risk of ATO-associated hepatotoxicity under different time intervals or based on gender and age stratification.A total of 2,549 patients, with 1,518 filling the ATO prescription first and 1,031 filling the ATO prescription second, were analyzed. After setting the run-in period as 30 days and the time interval as 15, 30, 60, 90, 120, and 180 days, the ASRs were 1.492 (95% CI: 1.367-1.652), 1.399 (95% CI: 1.308-1.508), 1.280 (95% CI: 1.213-1.357), 1.292 (95% CI: 1.234-1.356), 1.278 (95% CI: 1.226-1.336), and 1.274 (95% CI: 1.229-1.323), respectively. No significant difference was observed between different genders and ages (χ2=0.161, P=0.688; χ2=1.565, P=0.211, respectively).This is the first study conducted in a real-world setting to evaluate the relationship between ATO and hepatotoxicity using the PSSA in a Chinese population. We found a 1.3- to 1.5-fold increase in risk of hepatotoxicity following ATO, with the greater risk occurring within the first 30 days of treatment.
