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治疗高血压的仿制药:它们真的等效吗?

Generic drugs for hypertension: are they really equivalent?

机构信息

Department of Pharmacotherapy and Translational Research and Division of Cardiovascular Medicine, Colleges of Pharmacy and Medicine, University of Florida, Gainesville, FL 32610-0486, USA.

出版信息

Curr Hypertens Rep. 2013 Aug;15(4):340-5. doi: 10.1007/s11906-013-0353-4.

Abstract

Many antihypertensive drugs are now available in generic formulations at fractions of the cost of their branded counterparts. In the United States, marketing approval for generic medications is usually granted by the Food and Drug Administration on the basis of two simple studies involving dissolution rates and bioavailability in 24 - 36 healthy people, without data regarding antihypertensive efficacy, safety, or long-term outcomes. This process leaves many true disciples of "Evidence-Based Medicine" in a quandary: prescribe only brand-name medications that have been demonstrated in clinical trials to both lower blood pressure and prevent cardiovascular events, or instead recommend lower-priced generic agents that are usually supported by no such data. This review summarizes the current evidence that generic antihypertensive drugs are likely to be safe and effective, may increase the probability of medication availability and adherence for many patients, but, by law, must have a different physical appearance than the original product.

摘要

现在有许多降压药以仿制药的形式出现,价格只是品牌药的一小部分。在美国,食品和药物管理局通常根据涉及 24-36 名健康人的溶解速率和生物利用度的两项简单研究,来批准仿制药的上市许可,而不提供关于降压疗效、安全性或长期结果的数据。这一过程让许多真正的“循证医学”信徒陷入困境:只开临床试验证明既能降低血压又能预防心血管事件的品牌药,还是推荐价格更低的仿制药,而这些仿制药通常没有这样的数据支持。这篇综述总结了目前的证据,表明仿制药降压药可能是安全有效的,可能会增加许多患者获得药物和坚持治疗的可能性,但根据法律规定,它们必须与原产品具有不同的物理外观。

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