A literature search on pharmacokinetic drug interactions of statins and analysis of how such interactions are reflected in package inserts in Japan
A literature search on pharmacokinetic drug interactions of statins and analysis of how such interactions are reflected in package inserts in Japan
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DOI：
10.1111/j.1365-2710.2004.00605.x
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发表时间：
2005-02-01
影响因子：
2
通讯作者：
Hasegawa, R
中科院分区：
文献类型：
--
作者：
Saito, M;Hirata-Koizumi, M;Hasegawa, R
背景和目标：他汀类药物（HMG-CoA还原酶抑制剂）是世界上最广泛使用的处方类药物之一，因为其具有优异的降胆固醇作用和总体安全性特征，但与某些其他药物的药代动力学相互作用直接或间接引起的罕见但致命的横纹肌溶解除外。由于药品的包装说明书是医疗保健提供者的主要信息来源，我们进行了文献检索，以检查日本批准的5种他汀类药物的包装说明书中提供的关键信息（辛伐他汀、阿托伐他汀、氟伐他汀、普伐他汀和匹伐他汀）。对1996年至2004年6月的MEDLINE进行了检索，以确定五种他汀类药物临床药代动力学药物相互作用的研究。我们主要收集他汀类药物与其他药物联合给药后的血药浓度下面积（AUC）信息。目前在日本使用的包装说明书是从网站上获得的药物和医疗器械管理局，而美国包装说明书是从食品和药物管理局website.Results：大多数的包装说明书列出的药物，相互作用与他汀类药物与大多数描述横纹肌溶解症的风险，因为在血液中的浓度增加的可能性。然而，仅在少数病例中提供了定量信息，如AUC变化。日本药品说明书中很少提供剂量调整说明。美国药品说明书列出了与日本药品说明书几乎相同的药物相互作用，尽管它们包含更多的定量数据，特别是典型的细胞色素P450（CYP1A1）抑制剂。所有药代动力学药物相互作用，包括潜在效应物的相关定量数据和相互作用机制的详细信息，需要在信息可用后尽快在包装说明书中提供，以确保有关药物的安全及正确使用。在包装说明书中包括这些信息将对医疗保健提供者提供非常有价值的帮助。
Background and objectives: Statins (HMG-CoA reductase inhibitors) are one of the most widely prescribed classes of drugs throughout the world, because of their excellent cholesterol-lowering effect and overall safety profile except for rare but fatal rhabdomyolysis arising either directly or indirectly by pharmacokinetic interactions with certain other drugs. As package inserts in pharmaceuticals are the primary source of information for health care providers, we carried out a literature search to examine how crucial information was provided in package inserts of five statins approved in Japan (simvastatin, atorvastatin, fluvastatin, pravastatin and pitavastatin).Methods: A MEDLINE search from 1996 to June 2004 was carried out to identify studies on clinical pharmacokinetic drug interactions for the five statins. We mainly collected information on area under plasma concentration (AUC) following co-administration of statins with other drugs. The current package inserts used in Japan were obtained from the website of the Pharmaceutical and Medical Device Agency whereas USA package inserts were obtained from the Food and Drug Administration website.Results: The majority of package inserts listed the drugs that interacted with statins with most describing the risk of rhabdomyolysis because of the possibility of increases in blood concentration. However, quantitative information such as change in AUC was provided in only a few cases. Instructions for dosage adjustment are seldom provided in the Japanese package inserts. USA package inserts list almost identical drug interactions as the Japanese package inserts, although they contain more quantitative data, especially for typical cytochrome P450 (CYP) inhibitors.Conclusion: All pharmacokinetic drug interactions including relevant quantitative data for potential effectors and details on mechanisms of interaction need to be given in package inserts as soon as the information becomes available, to ensure safe and proper use of the drugs concerned. Including such information in the package insert will be an extremely valuable aid for health care providers.