抗肥胖药物相关严重不良事件报告趋势分析。

IF 2.3 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Branislava B Raičević, Andrej Belančić, Nikola Mirković, Slobodan M Janković
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引用次数: 0

摘要

随着抗肥胖药物使用的增加,对其副作用的担忧,尤其是严重的副作用,也越来越多。因此,本研究的目的是利用与欧盟已批准销售的抗肥胖药物相关的疑似不良事件报告的趋势,试图揭示这些药物安全性的差异。该研究被设计为二次研究,基于向EudraVigilance数据库报告的药物不良反应(包括严重和非严重)数量的数据。通过Joinpoint趋势分析软件对六种抗肥胖药物的年度报告率趋势进行分析,该软件将趋势线划分为通过“Joinpoint”连接的最佳分段数,并测试每个分段内趋势的显著性。严重药物不良事件的发生趋势在抗肥胖药物中存在明显差异:所有药物在上市后的最初几年都有明显的增加趋势,只有西马鲁肽的年报告数持续增长(年变化+ 67.1%,p = 0.000)。相反,只有利拉鲁肽的非严重药物不良事件报告率持续增加(年变化+ 33.8%,p = 0.000),而包括西马鲁肽在内的其他抗肥胖药物在初始期后的趋势为负或无显著增加。综上所述,在目前批准的抗肥胖药物中,只有西马鲁肽的严重不良事件年度报告呈持续上升趋势,提示需要进一步研究其安全性信号。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analysis of Reporting Trends of Serious Adverse Events Associated With Anti-Obesity Drugs.

Concern over the side effects of anti-obesity medications, particularly if severe, has grown as their use has increased. Thus, the objective was to use trends in the reporting of suspected adverse events associated with anti-obesity medications that have been approved for sale in the European Union to attempt to uncover discrepancies in the safety of these medications. The study was designed as secondary research, based on data about the number of adverse drug reactions (both serious and non-serious) reported to the EudraVigilance database. Trends of the annual reporting rates for the six anti-obesity drugs were analyzed by the Joinpoint Trend Analysis Software that divides the trendline into an optimum number of segments connected by "joinpoints" and tests the significance of the trend within each segment. The trends of serious adverse drug events showed clear differences among the anti-obesity drugs: while all drugs had significant increasing trends during a few initial years after their appearance on the market, only the annual number of reports for semaglutide continued to grow ever since (annual change + 67.1%, p = 0.000). On the contrary, a continuous increase in the reporting rate of non-serious adverse drug events was observed only for liraglutide (annual change + 33.8%, p = 0.000) while for the other anti-obesity drugs, including semaglutide, the trends after the initial period were either negative or did not increase significantly. In conclusion, among the anti-obesity drugs currently approved, only semaglutide shows a continuously increasing trend in the annual reporting of serious adverse events, suggesting a need for further investigation of safety signals.

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来源期刊
Pharmacology Research & Perspectives
Pharmacology Research & Perspectives Pharmacology, Toxicology and Pharmaceutics-General Pharmacology, Toxicology and Pharmaceutics
CiteScore
5.30
自引率
3.80%
发文量
120
审稿时长
20 weeks
期刊介绍: PR&P is jointly published by the American Society for Pharmacology and Experimental Therapeutics (ASPET), the British Pharmacological Society (BPS), and Wiley. PR&P is a bi-monthly open access journal that publishes a range of article types, including: target validation (preclinical papers that show a hypothesis is incorrect or papers on drugs that have failed in early clinical development); drug discovery reviews (strategy, hypotheses, and data resulting in a successful therapeutic drug); frontiers in translational medicine (drug and target validation for an unmet therapeutic need); pharmacological hypotheses (reviews that are oriented to inform a novel hypothesis); and replication studies (work that refutes key findings [failed replication] and work that validates key findings). PR&P publishes papers submitted directly to the journal and those referred from the journals of ASPET and the BPS
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