Association of atorvastatin with the risk of hepatotoxicity: a pilot prescription sequence symmetry analysis
Received 11 February 2019
Accepted for publication 27 May 2019
Published 27 June 2019 Volume 2019:15 Pages 803—810
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Colin Mak
Peer reviewer comments 2
Editor who approved publication: Professor Deyun Wang
Haiping Zhang,1 Jiani Wu,1 Zhuolin Zhang,2 Haisheng Qian,3 Yifan Wang,1 Miaomiao Yang,1 Yinchu Cheng,4 Shaowen Tang1
1Department of Epidemiology, School of Public Health, Nanjing Medical University, Nanjing 211166, Jiangsu, People’s Republic of China; 2Department of Clinical Pharmacy, School of Pharmacy, Nanjing Medical University, Nanjing 211166, Jiangsu, People’s Republic of China; 3Department of Internal Medicine, The First Clinical Medical College, Nanjing Medical University, Nanjing, Jiangsu 210029, People’s Republic of China; 4Department of Pharmacy, Peking University Third Hospital, Beijing 100191, People’s Republic of China
Purpose: 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.
Methods: 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.
Results: 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).
Conclusion: 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.
Keywords: atorvastatin, hepatoprotective drug, prescription sequence symmetry analysis, health insurance database
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