Abstract: PO2398
Risk of Bias in Observational Studies Assessing the Relationship Between Proton Pump Inhibitors and Adverse Kidney Outcomes
Session Information
- CKD: Qualitative and Quantitative Observational Studies
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Rajan, Pradeep, CERobs Consulting, Chapel Hill, North Carolina, United States
- Iglay, Kristy, CERobs Consulting, Chapel Hill, North Carolina, United States
- Rhodes, Thomas, CERobs Consulting, Chapel Hill, North Carolina, United States
- Girman, Cynthia J., CERobs Consulting, Chapel Hill, North Carolina, United States
- Bennett, Dimitri, Takeda Pharmaceuticals International AG, Cambridge, Massachusetts, United States
- Kalantar-Zadeh, Kamyar, University of California Irvine, Irvine, California, United States
Background
Proton pump inhibitors (PPIs) are widely prescribed as acid-suppression therapy. However, some observational studies suggest that long term use of PPIs is potentially associated with adverse kidney outcomes. We assessed potential bias in observational studies reporting on putative associations between PPIs and adverse kidney outcomes: AKI, acute interstitial nephritis, acute tubular necrosis, CKD, ESRD.
Methods
Searches in EMBASE and PubMed identified relevant English language articles published in the last 10 years. Risk of bias on an outcome-specific basis was evaluated using Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) by 2 independent reviewers (PROSPERO Registration: CRD42021227555).
Results
Of 620 identified records, 26 studies met a priori eligibility criteria and underwent risk of bias assessment. 19 studies were rated as having a moderate risk of bias for the reported adverse kidney outcomes, while 6 studies were rated as having a serious risk of bias (mainly due to inadequate control of confounders and selection bias) (Table 1). Effect estimates for the association between PPI and adverse kidney outcomes varied widely (0.24-7.34) but were mostly positive.
Conclusion
Observational studies suggesting kidney harm by PPIs were found to have a moderate to serious risk of bias using the ROBINS-I tool, making it challenging to establish causality. Additional high-quality, real-world evidence among generalizable populations is needed to better understand the relation between PPI treatment and acute/chronic kidney outcomes, taking into account the effects of varying time periods of PPI treatment, potential self-treatment with over-the-counter PPIs, and adequate control for potential critical confounders.
ROBINS-I
Funding
- Commercial Support –