プラバスタチン製剤先発医薬品と後発医薬品における臨床効果の比較

概要

論文の詳細を見る
In the present study, we retrospectively evaluated the efficacy and safety of pravastatin sodium after switching from the branded product to a generic. Our subjects were 27 type II diabetes mellitus patients aged 52-87 years with hyperlipidemia as a complication, who received the branded product for 12 weeks and were followed up for more than 12 weeks after switching to the generic product. No significant differences were noted between the branded and generic products as regards serum lipids, creatine phosphokinase (measured in 6 patients), or biochemical parameters of hepatic and renal function. We may therefore conclude that the branded and generic pravastatin administered in this study had similar efficacy and safety profiles.
日本医療薬学会の論文
2006-09-10