Lung Cancer Adverse Events Reports for Angiotensin-Converting Enzyme Inhibitors: Data Mining of the FDA Adverse Event Reporting System Database

Frontiers in Medicine

JunQing Yang¹  Shusen Sun²  Feng Qiu³  Long Meng³  Jing Huang⁴  Yuntao Jia⁵  Bing Yang⁶ 

[1] Department of Pharmacology, Chongqing Medical University, Chongqing, China;Department of Pharmacy Practice, College of Pharmacy and Health Sciences, Western New England University, Springfield, MA, United States;Department of Pharmacy, Xiangya Hospital Central South University, Changsha, China;Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China;Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China;Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Pediatrics, Department of Pharmacy, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing, China;Nursing College, Chongqing Medical University, Chongqing, China;

关键词: angiotensin-converting enzyme inhibitors;    lung cancer;    pharmacovigilance;    data mining;    FAERS;   

DOI  :  10.3389/fmed.2021.594043

来源: Frontiers

【 摘 要 】

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.

【 授权许可】

CC BY