OBJECTIVE: To compare the clinical efficacy and safety between domestic atorvastatin calcium tablets and original atorvastatin calcium tablets

so as to provide reference for clinical medication. METHODS: Mar. 23 rd

2019

which was the first day of the official implementation of the“4 + 7”quantity procurement policy in Beijing

was set as the time node

and the data of patients taking atorvastatin calcium tablets in outpatient or inpatient of Beijing Shijingshan Hospital（ hereinafter referred to as“our hospital”） for 3 months before and after the time node（ from Dec.23 rd

2018 to Jun. 23 rd

2019） were retrieved from HIS of our hospital. The data were divided into control group（ who had been taking original atorvastatin calcium tablets）

observation group 1（ who had been taking domestic atorvastatin calcium tablets） and observation group 2（ who had been taking original atorvastatin calcium tablets before the time point and domestic atorvastatin calcium tablets after the time point）. The total cholesterol

triglycerides

low density lipoprotein cholesterin and high density lipoprotein cholesterin were used as efficacy-related indicators

and the aspartate aminotransferase

alanine aminotransferase and creatine kinase were used as safety-related indicators

so that the levels of these indicators were compared and analyzed among three groups. Totally 22 829 patients took atorvastatin calcium tablets in our hospital from Dec. 23 rd

2018 to Jun. 23 rd

2019

including 18 183 cases were outpatients and 4 646 cases were inpatients. After manual screening

a total of 388 patients met the requirements for enrollment in the effectiveness study and420 patients met the requirements for enrollment in the safety study. RESULTS: There were no statistically significant differences in the efficacy-related indicators of between observation group 1/observation group 2 and the control group（ P >0. 05）; there was no statistically significant difference in the safety-related indicators between observation group 1/observation group 2 and the control group（ P > 0. 05）. CONCLUSIONS: The domestic atorvastatin calcium tablets have similar efficacy and safety with the original atorvastatin calcium tablets; compared with original atorvastatin calcium tablets

the domestic atorvastatin calcium tablets have more advantages in terms of price

which can reduce the economic burden of patients while ensuring the efficacy and can be used safely in clinical practice.