2011 年 37 巻 8 号 p. 449-455
We conducted a retrospective assessment of the efficacy and safety of pravastatin sodium in the case of switching from the branded drug to a generic version. The assessment was conducted on 1,337 hyperlipidemic patients at the Kameda General Hospital who had received the branded medicine for more than 28 days before substitution and the generic medicine for more than 28 days after substitution. We investigated the clinical equivalency with regard to efficacy indices including total cholesterol (TC), HDL cholesterol (HDL-C), LDL cholesterol (LDL-C), and triglyceride (TG) levels, as well as safety indices including aspartete transferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (γ-GTP), creatine phosphokinase (CPK), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), total-bilirubin (T-Bil), blood urea nitrogen (BUN), and serum creatinine (Scr) levels. There were no significant differences in the efficacy and safety indices between before and after substitution.
In subgroup analyses by glycated hemoglobin (HbA1c) or age there were also no significant differences between before and after substitution in the efficacy and safety indices. Detailed investigations on patients whose safety indices deteriorated to 2 or above (CTCAE v3.0 JCOG) showed that in most cases this was due to temporary changes in medical conditions, surgery, or fever. There were 14 patients who had stopped taking the generic possibly due to adverse events but there was no definite causal relationship between them and the generic. We concluded that the generic version of pravastatin administered in this study had similar efficacy and safety profiles to the branded medicine.