Proton pump inhibitors associated acute kidney injury and chronic kidney disease: data mining of US FDA adverse event reporting system

Bin Wu,Zhiyao He,Ting Xu,Min Luo,Yuwen Li,Dan Li

doi:10.1038/s41598-021-83099-y

Bin Wu, Zhiyao He + Show 4 more

Open Access

https://doi.org/10.1038/s41598-021-83099-y

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Abstract

Proton pump inhibitors (PPIs) were widely used. Observational studies suggested increasing risk of kidney injury in patients with PPIs treatment. We gathered six PPI regimens and adverse reports of acute kidney injury (AKI) and chronic kidney disease (CKD) based on US FDA Adverse Event Reporting System (FAERS) database from 2004 to 2019. We employed reporting odds ratio (ROR) to detect signals. Finally, we identified 3187 PPIs-associated AKI cases and 3457 PPIs-associated CKD cases. We detected significant signals between PPIs and AKI as well as CKD. The signal strength was stronger for CKD (ROR = 8.80, 95% CI 8.49–9.13) than AKI (ROR = 3.95, 95% CI 3.81–4.10), while dexlansoprazole performed stronger association for CKD (ROR = 34.94, 95% CI 30.89–39.53) and AKI (ROR = 8.18, 95% CI 7.04–9.51) than the other five PPIs. The median time from PPIs use to event occurrence was 23 days for AKI and 177 days for CKD. PPIs-associated AKI resulted larger proportion of death, life-threatening, hospitalization and disability events than PPIs-associated CKD. By mining the FAERS big data, we provided more information between PPIs use and the AKI and CKD events. PPIs rational use should be repeatedly stressed.

Highlights

Proton pump inhibitors (PPIs) were widely used to treat peptic ulcer disease (PUD), gastroesophageal reflux disease (GERD), Helicobacter pylori infection, and to prevent side effects of glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs)[1]
We further identified 3187 and 3457 PPIs users reported by health professionals with acute kidney injury (AKI) and chronic kidney disease (CKD) events, respectively (Table 1). 1096 (34.39%) cases reported more than one kinds of PPIs in AKI group, the number was 1748 (51.61%) in CKD group
The present study identified six PPIs-associated AKI and CKD signals based on the food and drug administration (FDA) Adverse Event Reporting System (FAERS) data

Summary

Introduction

Proton pump inhibitors (PPIs) were widely used to treat peptic ulcer disease (PUD), gastroesophageal reflux disease (GERD), Helicobacter pylori infection, and to prevent side effects of glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs)[1]. Adverse event reporting system data was an outstanding source for post-marketing drug safety monitoring and pharmacovigilance analysis. To the end of 2019, FAERS had collected more than ten million of cases, containing adverse drug event reports submitted by healthcare professionals, manufacturers, consumers and lawyers. These reports could be quantitatively analyzed using data mining methods to detect signals of drug-associated adverse events[14,15]. The objective of present study was to detect the signal of PPI-associated renal injury by systematically assessing spontaneous reports submitted to the FAERS database

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