University of New Mexico Health Sciences Center, Albuquerque, New Mexico 87111, USA.
Thromb Res. 2011 Jun;127(6):518-24. doi: 10.1016/j.thromres.2011.03.022. Epub 2011 May 6.
New and generic forms of widely used medications introduced in the antiplatelet, anticoagulant and fibrinolytic therapeutic classes will have a world-wide impact on prescribing, practice guidelines, and routine patient care. However, several uncertainties regarding these agents will remain even after the publication of their respective pivotal trials or regulatory approval. These questions include dosing in the frail, the elderly, and in those with renal and/or hepatic dysfunction, timing of administration in the peri-operative period, efficacy and safety in subgroup populations such as patients with cancer, the interchangeability of biosimilar products, and outcome differences between new agents in the absence of head-to-head clinical trials. Additionally, new generic forms of widely used agents have recently impacted the United States (US) and Canadian market place and more are under development. Clinicians should be vigilant concerning these agents and be prepared to inform patients and make decisions with their use.
新型和通用形式的广泛使用的药物在抗血小板、抗凝和纤维蛋白溶解治疗类别中的引入将对处方、实践指南和常规患者护理产生全球性影响。然而,即使在各自的关键试验或监管批准公布后,这些药物仍存在几个不确定性。这些问题包括在体弱、老年人、肾功能和/或肝功能不全者中的剂量、围手术期的给药时间、在癌症患者等亚群人群中的疗效和安全性、生物类似产品的可互换性以及在缺乏头对头临床试验的情况下新型药物之间的结果差异。此外,最近新型通用形式的广泛使用的药物已经影响了美国(US)和加拿大的市场,并且还有更多药物正在开发中。临床医生应该对这些药物保持警惕,并准备好告知患者并在使用这些药物时做出决策。