Lung Cancer Adverse Events Reports for Angiotensin-Converting Enzyme Inhibitors: Data Mining of the FDA Adverse Event Reporting System Database.
Lung Cancer Adverse Events Reports for Angiotensin-Converting Enzyme Inhibitors: Data Mining of the FDA Adverse Event Reporting System Database.
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DOI：
10.3389/fmed.2021.594043
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发表时间：
2021
影响因子：
3.9
通讯作者：
Huang J
中科院分区：
文献类型：
--
作者：
Meng L;Yang B;Qiu F;Jia Y;Sun S;Yang J;Huang J
由于来自临床试验的相互矛盾的证据，血管紧张素转换酶抑制剂（ACEIs）与肺癌之间的关系需要进一步评估。因此，目前的研究是利用药物警戒方法评估向FDA不良事件报告系统提交的acei报告中原发性恶性肺癌的不成比例报告。我们通过计算报告的优势比（ROR）和95%置信区间（CI）的信息成分（IC），对10例acei相关的原发性恶性肺癌不良事件进行了歧化分析。通过逻辑回归分析调整了性别、年龄和报告年份的ROR。从2004年1月到2020年3月，共发现了622例acei使用者肺癌不良事件报告。ACEIs作为药物类别存在显著不成比例的关联（ROR: 1.22, 95% CI: 1.13-1.32; IC: 0.28, 95% CI: 0.17-0.39）。校正ROR: 1.23, 95% CI: 1.02-1.49)。在基于性别的分层后，亚组分析表明女性患者表现出显著的不成比例的关联，而男性患者则没有。通过报告地区、合并症和报告年份限制数据的敏感性分析也显示出类似的趋势。在接受ACEI治疗的患者中，尤其是女性患者中检测到的肺癌信号具有统计学意义。FAERS数据库的不相称性分析表明，ACEI使用者中肺癌的报告略有增加。需要进一步进行强有力的流行病学研究来证实这一关系。
Because of contradictory evidence from clinical trials, the association between angiotensin-converting enzyme inhibitors (ACEIs) and lung cancer needs further evaluation. As such, the current study is to assess disproportionate reporting of primary malignant lung cancer among reports for ACEIs submitted to the FDA adverse event reporting system utilizing a pharmacovigilance approach. We conducted a disproportionality analysis of primary malignant lung cancer adverse events associated with 10 ACEIs by calculating the reported odds ratios (ROR) and information component (IC) with 95% confidence intervals (CI). ROR was adjusted for sex, age, and reporting year by logistic regression analyses. From January 2004 to March 2020, a total of 622 cases of lung cancer adverse event reports were identified for ACEIs users. Significant disproportionate association was found for ACEIs as a drug class (ROR: 1.22, 95% CI: 1.13–1.32; IC: 0.28, 95% CI: 0.17–0.39. adjusted ROR: 1.23, 95% CI: 1.02–1.49). After stratification based on gender, a subset analysis suggested that female patients exhibited a significant disproportionate association, while male patients did not. Sensitivity analyses that limited the data by reporting region, comorbidity, and reporting year also showed similar trends. Statistical significant lung cancer signals were detected among patients who received ACEI, especially female patients. The disproportionality analysis of the FAERS database suggests mildly increased reporting of lung cancer among ACEI users. Further robust epidemiological studies are necessary to confirm this relationship.
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影响因子：
2.6
作者：
Gokhale M;Girman C;Chen Y;Pate V;Funk MJ;Stürmer T
通讯作者：
Stürmer T
影响因子：
3.5
作者：
Munoz, Miguel;Covenas, Rafael
通讯作者：
Covenas, Rafael
影响因子：
2.6
作者：
Holmes, Signy;Griffith, E. Jane;Minuk, Gerald Y.
通讯作者：
Minuk, Gerald Y.
影响因子：
4
作者：
Lu, Dah-Yuu;Leung, Yuk-Man;Wong, Kar-Lok
通讯作者：
Wong, Kar-Lok
DOI：
10.1136/bmj.k4209
发表时间：
2018-10-24
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Hicks BM;Filion KB;Yin H;Sakr L;Udell JA;Azoulay L
通讯作者：
Azoulay L