塩酸メトホルミン製剤先発医薬品から後発医薬品へ切り替えによる臨床効果の比較

概要

論文の詳細を見る
In recent years, there has been a growing tendency to use generic drugs though there have been few studies on their efficacy and safety. However, there have been reports of decreased efficacy and more adverse effects with the use of generics which indicates that they are not equivalent to branded products. We retrospectively compared the efficacy and safety of generic metformin hydrochloride (Medet^[○!R]) with the branded product (Merbin^[○!R]) when a switch was made from the branded product to the generic. Regarding efficacy, there were no significant differences in Hemoglobin A_<1c>(HbA_<1c>) levels between before switching to Medet^[○!R] and three months after switching (6.89±0.77%→6.70±0.70% (at time of switch)→6.80±0.85% : N.S.). We also analyzed drug safety using ALT, AST, γ-GTP, ALP and found no specific problems related to the switch to Medet^[○!R]. However an investigation of 274 subjects after switching to Medet^[○!R] revealed that there had been adverse effects in 10 of them. While our findings suggest that the branded and generic products of metformin hydrochloride have similar efficacy, attention should be paid to the appearance of adverse effects after switching to a generic version.
日本医療薬学会の論文
2007-11-10