Adverse effects of proton pump inhibitors (PPIs) on the renal system using data mining algorithms (DMAs)

We have examined the adverse effects of proton pump inhibitors (PPIs) on the renal system using data from FDA Adverse Event Reporting System of the USA between 1 January 2004 and 30 September 2021. After doing the subgroup as well as sensitivity analysis, we have identified a positive signal of susp...

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Vydáno v:Expert opinion on drug safety Ročník ahead-of-print; číslo ahead-of-print; s. 1 - 12
Hlavní autoři: Jain, Devanshi, Sharma, Gazal, Kumar, Anoop
Médium: Journal Article
Jazyk:angličtina
Vydáno: England Taylor & Francis 03.08.2023
Témata:
data mining algorithms (DMAs)
Proton pump inhibitors
renal system
signal detection
Proton pump inhibitors
data mining algorithms (DMAs)
signal detection
renal system
ISSN:1474-0338, 1744-764X, 1744-764X
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Shrnutí:We have examined the adverse effects of proton pump inhibitors (PPIs) on the renal system using data from FDA Adverse Event Reporting System of the USA between 1 January 2004 and 30 September 2021. After doing the subgroup as well as sensitivity analysis, we have identified a positive signal of suspected chronic kidney disease, acute kidney injury, renal failure, renal injury, and end-stage renal disease with selected PPIs. Therefore, the adverse effects of selected PPIs on the renal system should be considered and further causality assessment should be performed to confirm the association. Various adverse drug reactions (ADRs) are associated with proton pump inhibitors (PPIs). However, the effects of PPIs on the renal system are unclear so far. Thus, the main objective of the current study was to identify the possible signals of PPIs in the renal system. Data mining algorithms such as proportional reporting ratio i.e. PRR (≥2) with associated chi-squared value (>4), reporting odds ratio i.e. ROR (≥2) with 95% confidence interval and case count (≥3) were calculated to identify a possible signal. The calculated PRR and ROR have indicated a positive signal of PPIs with suspected chronic kidney disease, acute kidney injury, renal failure, renal injury, and end-stage renal disease. The subgroup analysis results have shown a greater number of cases in the age group (18-64 years) as compared to other age groups whereas the number of cases in the female was found to be more as compared to males. The sensitivity analysis results have also shown no significant impact of concomitantly administered drugs on the outcome. PPIs may be associated with various ADRs on the renal system.
Bibliografie:ObjectType-Article-1
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ISSN:1474-0338
1744-764X
1744-764X
DOI:10.1080/14740338.2023.2189698