PEPPER: Bestimmung der optimalen Strategie zum Absetzen einer chronischen Protonenpumpeninhibitor-Therapie bei Patienten in der Primärversorgung: Auswirkungen der bedarfsgerechten Anwendung, von Begleittherapien und Antazida (KCE-201277)

Determining the optimal strategy for stopping chronic proton pump inhibitor therapy in primary care patients: impact of on-demand use, adjunctive therapies and antacids.

Participants (P)

Patients on long-term (>12 weeks) chronic PPI use without therapy indication are eligible to participate.

Based on dose:

Patients on a “maintenance” PPI dose are eligible for randomization. Maintenance dose is 20 mg of omeprazole, esomeprazole or pantoprazole daily or 15 mg of lansoprazole daily or 10 mg of rabeprazole daily.

Patients on “healing” PPI dose (i.e. ≥40 mg esomeprazole, esomeprazole or pantoprazole or ≥30 mg of lansoprazole or ≥20 mg or rabeprazole daily) are also eligible for the study, but need first to down-titrate their dose to “maintenance” dose before they can be considered for randomization.

Intervention (I)

Chronic PPI therapy is changed to on-demand therapy approach for one month. The dose PPI should be maintenance dose (the lowest dose). PPI intake should occur only when needed to reduce symptoms, followed by PPI interruption. When symptoms recur during this month, the patient restarts PPI intake until symptoms again resolve, upon which the intake of medication is again stopped.

PPI therapy is stopped and replaced by alginate formulation for one month. Alginates have shown effectively reducing GERD symptoms and have shown 38 to 40% success rate as deprescribing therapy. After one month, the use of alginates is stopped.

All patients will receive guidelines for antacid use and will be followed up for 1 year. Antacids excluded for use during the study: drugs based on magaldrate such as Riopan® and Gastricalm® and Syngel® as it also includes lidocaine and it is not considered a standard antacid.

Control (C)

The comparator for this study will be a gradually decreasing intermittent dosing scheme for one month before stopping the PPI, which is in line with the Belgian guidelines and was already used in a Belgian primary care study.

Outcome (O)

To evaluate the best PPI deprescribing strategy in primary care patients who are chronically using PPIs without an established indication

Trial Design

Open label, parallel-group randomized trial

Sample Size

609

Trial duration

29 months

Budget

1.96 Mio

6 Academic centers (UA, KU Leuven, U Liège, UCL, ULB, U Gent)

75 GPs