ABSTRACT
Objective To study the association between statins use and liver-injury through prescription sequence symmetry analysis (PSSA) and evaluate the feasibility of the method to be used in Chinese Medical Insurance Database.Methods The data of the patients who prescribed both statins and liver-proactive drugs in Chinese Basic Medical Insurance Database in 2013 were selected as study subjects to calculate the adjusted sequence ratio (ASR) with signal detection methods to determine the study parameters and investigate the potential association between statins use and liver-injury.Results In 5 649 individuals which met the inclusion criteria,the washout period was set as one month and interval period was set as 60 days.The overall ASR of statins was 1.471(95％CI:1.395-1.550),the ASR of atorvastatin was 1.419 (95％CI:1.335-1.508),the ASR of simvastatin was 1.307 (95％CI:1.164-1.467).The positive signal was strong in 30 days interval period.Conclusions PSSA indicated that there might be potential association between statins use and liver-injury,especially the uses of atorvastatin and simvastatin.This signal detection method may be a fast and effective method in drug safety evaluation and can be used in Chinese Medical Insurance Database.
ABSTRACT
Objective To study the association between statins use and liver-injury through prescription sequence symmetry analysis (PSSA) and evaluate the feasibility of the method to be used in Chinese Medical Insurance Database.Methods The data of the patients who prescribed both statins and liver-proactive drugs in Chinese Basic Medical Insurance Database in 2013 were selected as study subjects to calculate the adjusted sequence ratio (ASR) with signal detection methods to determine the study parameters and investigate the potential association between statins use and liver-injury.Results In 5 649 individuals which met the inclusion criteria,the washout period was set as one month and interval period was set as 60 days.The overall ASR of statins was 1.471(95％CI:1.395-1.550),the ASR of atorvastatin was 1.419 (95％CI:1.335-1.508),the ASR of simvastatin was 1.307 (95％CI:1.164-1.467).The positive signal was strong in 30 days interval period.Conclusions PSSA indicated that there might be potential association between statins use and liver-injury,especially the uses of atorvastatin and simvastatin.This signal detection method may be a fast and effective method in drug safety evaluation and can be used in Chinese Medical Insurance Database.