後発医薬品(シンバスタチン製剤)の治療学的同等性に関してのレトロスペクティブな使用実態調査成績

概要

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We conducted a retrospective study to determine whether a brand-name simvastatin (Lipovas^[○!R]) is therapeutically equivalent to a generic simvastatin (Lipodown^[○!R]). One hundred and sixty-nine subjects were chosen from among hyperlipidemia patients who had been visiting Keihanna Hospital and Matsumoto Medical Clinic. These patients had been switched from the brand name simvastatin, Lipovas^[○!R] to the generic product Lipodown^[○!R] in the course of their treatment for hyperlipidemia. Clinical data for 36 of the 169 subjects were analyzed. Regarding efficacy, no significant differences were seen in total cholesterol levels before switching to Lipodown^[○!R] and six months after switching (217.6±36.7mg/dL→212.4±26.1mg/dL (at time of switch)→209.9±27.7mg/dL, P=0.11), and this was also the case for HDL-cholesterol, LDL-cholesterol, and triglyceride levels. We also analyzed drug safety using AST, ALT, γ-GTP, BUN, Creatinine and CPK as indices and found no specific problems related to the switch to Lipodown^[○!R]. These results suggest that Lipovas^[○!R] and Lipodown^[○!R] are therapeutically equivalent, and that Lipodown^[○!R] can be used clinically in place of Lipovas^[○!R] so long as essential markers like ALT, AST, γ-GTP, and CPK are carefully monitored.
日本医療薬学会の論文
2006-11-10