Lexchin Joel
Professor Emeritus, School of Health Policy and Management, York University, Emergency Physician, University Health Network, Associate Professor, Department of Family and Community Medicine, University of Toronto, Toronto, ON.
Healthc Policy. 2016 Nov;12(2):65-75.
First-in-class drugs use a unique mechanism of action. This study assessed the therapeutic innovativeness and safety of these drugs approved by Health Canada from 1997-2012.
A list of new drugs was compiled and a database from the Food and Drug Administration was used to determine first-in-class status. Post-market safety warnings and drugs withdrawn for safety reasons were identified from the MedEffect Canada website. Therapeutic innovation evaluations came from the Patented Medicine Prices Review Board (PMPRB) and Prescrire International. The proportion of first-in-class drugs that were innovative was compared to the proportion of non-first-in-class drugs that were innovative. Kaplan-Meier survival curves assessed safety.
In all, 462 drugs were approved by Health Canada during the period under study. Among these, 345 were evaluated by PMPRB and/or Prescrire, and first-in-class data were available for 292. Ninety-eight of the 292 were first-in-class and 16 were innovative compared to 9 of 194 drugs that were not-first-in-class. There was no difference in safety between the two groups.
Overall, the benefit-to-harm ratio of first-in-class drugs, as measured by post-market safety warnings/withdrawals, is better than those that were not-first-in-class.
一流药物采用独特的作用机制。本研究评估了1997年至2012年期间加拿大卫生部批准的这些药物的治疗创新性和安全性。
编制新药清单，并使用美国食品药品监督管理局的数据库来确定一流药物的地位。从加拿大药品不良反应监测网站上识别上市后安全警告和因安全原因撤市的药物。治疗创新评估来自专利药品价格评审委员会（PMPRB）和《Prescrire国际》。将一流创新药物的比例与非一流创新药物的比例进行比较。采用Kaplan-Meier生存曲线评估安全性。
在研究期间，加拿大卫生部共批准了462种药物。其中，345种由PMPRB和/或《Prescrire国际》进行了评估，292种有一流药物的数据。292种一流药物中有98种，194种非一流药物中有16种具有创新性。两组之间的安全性没有差异。
总体而言，根据上市后安全警告/撤市情况衡量，一流药物的利弊比优于非一流药物。
