プラバスタチン製剤の後発医薬品(メバン錠^<TM>)への切り替えに伴う治療学的同等性に関するレトロスペクティブ解析

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Pravastatin sodium tablets are widely used for the treatment of hyperlipidemia, and 22 generic products of this compound have been approved in Japan. A few studies have compared the clinical efficacy of the original and generic forms, and 1 study has questioned the reliability of biological equivalency tests. We therefore retrospectively examined the effect of substituting a generic product (Mevan^<TM>; Nichi-iko Pharmaceutical Co., Ltd.) for the original product (Mevalotin^<TM>; Daiichi Sankyo Co., Ltd.) on clinical efficacy and safety. We targeted patients who were initially treated with the original product and then the generic product, and from electronic medical records, obtained their prescription data for 3 months before and after generic substitution. Next, we investigated clinical equivalence with regard to changes in total cholesterol (TC), HDL cholesterol (HDL), LDL cholesterol (LDL), and triglyceride (TG) levels as indices of clinical efficacy, as well as in ALT, AST, γ-GTP, and CPK levels as indices of safety. We examined the changes in each of these laboratory parameters between 3 months before substitution and 3 months after substitution. In 293 patients, no significant differences were observed in the indices of efficacy between before and after substitution. We also examined records for presence of diabetes mellitus and familial hypercholesterolemia and their influence on TC levels before and after substitution but no significant differences were observed in this regard. Accordingly, we concluded that the generic product investigated in this study was clinically as effective as the original product.
2008-04-10

プラバスタチン製剤の後発医薬品(メバン錠^<TM>)への切り替えに伴う治療学的同等性に関するレトロスペクティブ解析

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