Expert opinion on drug safety · 2021
Proton pump inhibitors and increased reporting odds of renal neoplasms: FAERS-based adverse event data mining and analysis.
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Song Weijuan, Shi Lei, Wang Yanhong, Zhang Zisen
Аннотация
BACKGROUND: Long-term use of proton pump inhibitors (PPIs) is associated with some safety issues. In this study, data mining was carried out to discover the potential association between renal neoplasms and PPIs.
RESEARCH DESIGN AND METHODS: Neoplasms signals of PPIs were detected in the Food and Drug Administration Adverse Event Reporting System from 2014 to 2020 by examining the reporting odds ratio. Adjusted odds ratios were analyzed using logistic regression.
RESULTS: Signals were detected with respect to renal hemangioma, acquired or unspecified cystic kidney disease, and papillary and unspecified renal cell carcinoma, of which intervals between adverse effects onset and medication were 7.00 (3.33, 15.67) years, 5.00 (1.70, 10.25) years, and 7.00 (4.72, 12.25) years, respectively. The lansoprazole had the strongest signal. Adjusted odds ratios for PPIs associated with renal cell carcinoma in cases with or without acquired cystic kidney disease or chronic kidney disease were 1.67 [95% confidence interval (CI) 1.46-1.91] and 1.62 (95% CI 1.41-1.87).
CONCLUSIONS: Exposure to PPIs was related to the raised risk of renal neoplasms. Careful consideration should be given to the possibility of an increased risk when PPIs are administered.
RESEARCH DESIGN AND METHODS: Neoplasms signals of PPIs were detected in the Food and Drug Administration Adverse Event Reporting System from 2014 to 2020 by examining the reporting odds ratio. Adjusted odds ratios were analyzed using logistic regression.
RESULTS: Signals were detected with respect to renal hemangioma, acquired or unspecified cystic kidney disease, and papillary and unspecified renal cell carcinoma, of which intervals between adverse effects onset and medication were 7.00 (3.33, 15.67) years, 5.00 (1.70, 10.25) years, and 7.00 (4.72, 12.25) years, respectively. The lansoprazole had the strongest signal. Adjusted odds ratios for PPIs associated with renal cell carcinoma in cases with or without acquired cystic kidney disease or chronic kidney disease were 1.67 [95% confidence interval (CI) 1.46-1.91] and 1.62 (95% CI 1.41-1.87).
CONCLUSIONS: Exposure to PPIs was related to the raised risk of renal neoplasms. Careful consideration should be given to the possibility of an increased risk when PPIs are administered.