Are novel drugs more risky for patients than less novel drugs?
Are novel drugs more risky for patients than less novel drugs?
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DOI：
10.1016/j.jhealeco.2004.03.007
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发表时间：
2004-11-01
影响因子：
3.5
通讯作者：
Olson, MK
中科院分区：
文献类型：
--
作者：
Olson, MK
美国食品和药物管理局（FDA）加快了治疗新药的审批，以便患者更快地获得创新药物疗法。然而，很少有研究考察治疗上新颖和不太新颖的药物之间的风险差异。代表更新奇的药物是否也会给患者带来更大的风险？本文使用FDA的上市后药物安全性监测数据来检查与新型和非新型药物相关的药物不良反应（ADR）。负二项回归用于检查药物的FDA新奇评级对其ADR计数的影响，控制药物利用，治疗条件，疾病特征，患者特征，药物审查时间和特定年份的影响。结果表明，FDA认为新颖的药物与更多的严重药物反应有关，包括导致住院和死亡的药物，而不是不那么新颖的药物。这些结果表明，相对于较不新颖的药物，新颖药物对患者造成更大的严重ADR风险：（C）2004 Elsevier B.V.保留所有权利。
The Food and Drug Administration has accelerated the approval of therapeutically novel drugs so that patients have faster access to innovative drug therapies. Little research, however, has examined the variation in risks among therapeutically novel and less novel drugs. Do drugs that represent greater novelty also entail greater risks for patients? This paper uses post-marketing drug safety surveillance data from the FDA to examine the adverse drug reactions (ADRs) associated with novel and less novel drugs. Negative binomial regressions are used to examine the impact of a drug's FDA novelty rating on its ADR count controlling for differences in drug utilization, the conditions being treated, disease characteristics, patient characteristics, drug review times, and year-specific effects. Results show that drugs deemed novel by the FDA are associated with a greater number of serious drug reactions, including those that result in hospitalization and death, than less novel drugs. These results suggest that novel drugs pose greater risk of serious ADRs for patients relative to less novel drugs: (C) 2004 Elsevier B.V. All rights reserved.