Primary carE PPi dEprescRibing (PEPPER) trial: a protocol for determining the optimal strategy for stopping chronic proton pump inhibitor therapy in primary care patients
Abstract
Introduction: Current Belgian guidelines state that chronic proton pump inhibitor (PPI) therapy is indicated for oesophagitis grade C and D, Barrett's oesophagus, Zollinger-Ellison syndrome, or to prevent bleeding ulcers with chronic non-steroidal anti-inflammatory drugs (NSAID) intake in patients at risk. Guidelines justify empiric short-term PPI therapy in other cases to control symptoms. Yet, there is insufficient PPI down-titration and/or cessation. As such, concerns have risen related to the impact of PPIs on the healthcare budget and increasing number of risks and side effects. This study aims to provide evidence to determine which strategy provides the most effective approach for stopping chronic intake of PPIs in patients in whom there is no firm medical indication for their continued use.
Methods and analysis: This is a multicentre, pragmatic, randomised clinical trial. General practitioners will randomise 609 to one of three PPI deprescription strategies. Patients on a high-dose PPI are allowed to participate after down-titrating their dose to a maintenance dose for 1 month before being randomised. Patients unable to decrease the high-dose PPI are not to be randomised. Following randomisation, patients will be requested to adapt their PPI intake for 1 month to the allocated deprescription scheme: (a) on-demand PPI intake, (b) replace PPI to alginate intake and (c) intermittent PPI intake with a fixed scheme. After successfully following the deprescription strategy,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- The Prediction of the In Vitro Release Curves for PLGA-Based Drug Delivery Systems with Neural Networks
- Promising Ursolic Acid as a Novel Antituberculosis Agent: Current Progress and Challenges
- Proof of principle concept for the analysis and functional prediction of rare genetic variants in the CYP2C19 and CYP2D6 genes
- Fabrication, characterization, and docking studies of furosemide-loaded nanosponges using the emulsion solvent diffusion method
- The Effect of Concomitant Administration of Proton Pump Inhibitors on the Pharmacokinetics of CDK4/6 Inhibitors in Rats: Implications for the Evaluation of Hepatic and Transporter-Mediated Drug–Drug Interactions
- Mining the Metabolic Capacity of Clostridium sporogenes Aided by Machine Learning
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.