Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.
Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.
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DOI：
10.1111/jcpt.12646
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发表时间：
2018-06
影响因子：
2
通讯作者：
Hansen RA
中科院分区：
文献类型：
--
作者：
Alatawi Y;Rahman MM;Cheng N;Qian J;Peissig PL;Berg RL;Page CD;Hansen RA
就品牌药和非专利药是否产生相同的结果而言，一些公众对非专利药存在怀疑。本研究使用授权仿制药（AGs）作为可能的仿制药认知偏差的对照，探讨品牌药和仿制药之间的不良事件（AE）报告模式是否相似。分析2004-2015年向FDA不良事件报告系统报告的事件。根据药品和制造商的名称，将药品分为品牌、AG和仿制药。如果氨氯地平、氯沙坦、美托洛尔缓释（ER）或辛伐他汀被列为主要或次要可疑药物，则纳入报告。使用报告优势比（ROR）的歧化分析评估了报告标记不良事件与报告所有其他药物不良事件的相对比率。Breslow Day测试比较了品牌、AG和仿制药的RORs。中断时间序列分析评估了通用分录对报告趋势的影响。仿制药占美国总报告的很大比例，但AGs占报告的比例较小，包括氨氯地平（14.26%）、氯沙坦（1.48%）、美托洛尔ER（0.35%）和辛伐他汀（0.70%）。虽然多品牌与通用比较的误差率有显著差异，但AG与通用比较产生的统计显著结果较少。即，氨氯地平伴外周水肿，AG组的ROR与普通组有差异（P < 0.01）。与AG和仿制药相比，在品牌和仿制药之间观察到更多不一致的报告模式。使用AGs作为对泛型的感知偏差的控制是有用的，但这种方法可能受到较小的AG报告数量的限制。要求在处方瓶或包装上印刷制造商名称可以提高所报告产品分配的准确性。
Some public skepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases. Events reported to the FDA Adverse Event Reporting System from the years 2004–2015 were analyzed. Drugs were classified as brand, AG, or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended-release (ER), or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labeled AEs compared to reporting these AEs with all other drugs. The Breslow Day test compared RORs across brand, AG, and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%), and simvastatin (0.70%). While the RORs were significantly different for multiple brand vs. generic comparisons, the AG vs. generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral edema (P < 0.01). Inconsistent reporting patterns were observed more between brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported.
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影响因子：
15.8
作者：
Sarpatwari A;Choudhry NK;Avorn J;Kesselheim AS
通讯作者：
Kesselheim AS
DOI：
10.1046/j.1365-2710.2002.00430.x
发表时间：
2002-08-01
影响因子：
2
作者：
Wagner, AK;Soumerai, SB;Ross-Degnan, D
通讯作者：
Ross-Degnan, D
影响因子：
5.7
作者：
Ahmad, SR
通讯作者：
Ahmad, SR
影响因子：
3.3
作者：
Faasse, Kate;Cundy, Tim;Petrie, Keith J.
通讯作者：
Petrie, Keith J.
影响因子：
5.7
作者：
Kesselheim, Aaron S.;Gagne, Joshua J.;Campbell, Eric G.
通讯作者：
Campbell, Eric G.