HMG-CoA Reductase Inhibitor의 간독성 평가

Abstract

First statin approved by U.S Food and Drug Administration(FDA) in 1987 was Lovastatin and the statins are now one of the most widely prescribed classes of medications. The statins have shown evidence of reducing coronary heart disease events, but on the other hand they have been implicated in causing complications in muscle, liver and kidney. There’re no papers about hepatotoxicity in Koreans even though there’re a lot of papers about muscle-toxicity at home and abroad. So we have studied to assess the risk of liver function test (LFT) abnormalities with Koreans using statin. We retrospectively reviewed of Electronic Medical Records(EMR) of 12,860 new users of six statins(Atorvastatin, Fluvastatin, Lovastatin, Pitavastatin, Rosuvastatin, Simvastatin) during the period 1 May 2003 through 30 April 2006 in Seoul National University Hospital(SNUH).The patients in their 60s were the largest population (36.6%) and 55% of them were female. The spread of patients of statins indicated 30.4%, 2.2%, 8.7%, 1.1%, 10.6% and 47.0% in Atorvastatin, Fluvastatin, Lovastatin, Pitavastatin, Rosuvastatin and Simvastatin, respectively. Assessing LFT abnormalities, among the patients, 26.1% were more than mild(AST or ALT ＞40), 5.6% were more than moderate(AST or ALT ＞80) and 1.7% were more than severe(ALT or ALT ＞120). Especially, we’ve analyzed the data of Severe(AST or ALT ＞120) LFT abnormalities by using ‘Ranking by Clinical Significance of the Definition of Liver Function Test’to estimate hepatotoxicity clearly. This trial has revealed same result that all six statins have effecting severe hepatotoxicity around 1% with papers reported abroad. Also severe hepatotoxicity was related with dose but with age(p＜0.05). Severe hepatotoxicity is uncommon and is reported in less than 1% of the statins therapy but it is related with dose, it is important to check LFT periodically in case of high dose therapy.