Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, PO Box 80.082, 3508 TB, Utrecht, The Netherlands.
Eur J Clin Pharmacol. 2010 May;66(5):445-8. doi: 10.1007/s00228-010-0808-3. Epub 2010 Mar 12.
To provide an overview of and discuss newly authorised medicines with an improved efficacy.
This analysis focussed on new medicines with an improved efficacy based on the results of randomised active control trials. Information on comparative efficacy was obtained from the European Medicines Agency European Public Assessment Reports.
Between 1999 and 2005 we identified 122 new medicines with a new active substance. Of these, 13 (10%) were shown to be superior to already available medicines in terms a statistically significant difference in primary clinical endpoints.
A proven advantage in efficacy at an early stage of drug development is the exception rather than the rule. The absence of evidence demonstrating differences between medicines does not necessarily mean that there are no actual differences. Optimal pharmacotherapy would benefit from more comparative research in the development of new medicines. The results of comparative trials need to be critically evaluated for their specific value in clinical practice. To this end, prescription data may be helpful.
概述和讨论具有改善疗效的新批准药物。
本分析侧重于基于随机对照临床试验结果显示疗效改善的新药。比较疗效信息来自欧洲药品管理局的《欧洲公共评估报告》。
1999 年至 2005 年间，我们发现了 122 种具有新活性物质的新药。其中，有 13 种（10%）在主要临床终点方面显示出统计学意义上的优越性，优于已有的药物。
在药物开发的早期阶段，疗效的明显优势是例外而非规则。缺乏药物之间差异的证据并不一定意味着实际上没有差异。如果能在新药开发中开展更多的比较研究，优化药物治疗将从中受益。需要对比较试验的结果进行批判性评估，以确定其在临床实践中的具体价值。为此，处方数据可能会有所帮助。
