プラバスタチンNa錠の後発医薬品への切り替えに伴う臨床検査値に基づく臨床効果の評価および安全性評価

DOI

書誌事項

タイトル別名
  • Assessment of Efficacy and Safety of Branded and Generic Versions of Pravastatin Sodium Based on Laboratory Data: A retrospective analysis

この論文をさがす

抄録

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.<br>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.

収録刊行物

  • 医療薬学

    医療薬学 37 (8), 449-455, 2011

    一般社団法人日本医療薬学会

キーワード

詳細情報 詳細情報について

問題の指摘

ページトップへ