Guiding the safe reduction of unnecessary proton pump inhibitors

DepRescribing inapprOpriate Proton Pump InhibiTors - the DROPIT Trial: a Cluster Randomized Controlled Trial in Primary Care Setting

This study is testing a new way to help doctors safely reduce the use of unnecessary heartburn medications in patients to see if it works better than the usual approach.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Bern (Academic / other)
• Locations: 2 sites (Bern and 1 other locations)
• Trial ID: NCT06129474 on ClinicalTrials.gov

What this trial studies

The DROPIT Trial is an interventional, open-labelled, cluster-randomized controlled trial conducted in Swiss primary care settings. It aims to evaluate an intervention designed to guide the deprescribing of inappropriate proton pump inhibitors (PPIs) while ensuring patient safety. The trial will assess the effectiveness of this intervention compared to usual care, focusing on the deprescribing process, clinical outcomes, and cost-effectiveness. Additionally, the study will provide necessary tools and training for general practitioners and patients to facilitate safe deprescribing.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been taking proton pump inhibitors daily for at least 8 weeks and are prescribed higher-than-recommended doses.

Not a fit: Patients with a limited life expectancy or those who require proton pump inhibitors for established medical indications will not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could lead to safer medication practices and improved health outcomes for patients using proton pump inhibitors unnecessarily.

How similar studies have performed: Other studies have indicated that deprescribing interventions can be effective, suggesting that this approach may yield positive results as well.

Eligibility criteria

Inclusion Criteria:

1. Patient of a participating GP.
2. Age ≥18 years old.
3. Daily PPI intake for ≥8 weeks.
4. PPI in one of the following doses:

   * ≥40mg/day pantoprazole;
   * ≥40mg/day omeprazole;
   * \>30mg/day lansoprazole;
   * \>30mg/day dexlansoprazole;
   * \>20mg/day esomeprazole;
   * \>20mg/day rabeprazole.
5. Sufficient knowledge of German language to understand the trial and follow-up according to GP assessment.

Exclusion Criteria:

1. Limited life expectancy according to GP judgement (patients with terminal disease and a life expectancy \< 12 months.
2. Unable to provide informed consent.
3. PPI in an appropriate dose (see Appendix Table A1) and with an established indication for long-term PPI, such as:

   * History of bleeding ulcer.
   * Peptic ulcer due to cause other than NSAID or H. Pylori.
   * Barrett's oesophagus.
   * Severe erosive reflux disease (Los Angeles grade C/D).
   * GERD with symptoms or complications (oesophageal ulcer, peptic stricture).
   * Other indications (i.e., Zollinger-Ellison-Syndrome, PPI-sensitive eosinophilic esophagitis, chronic pancreatitis with steatorrhea refractory to enzyme replacement therapy, idiopathic pulmonary fibrosis.)
4. Two or more of the following medications, or one of the following medications and one or more of the below risk factors.

Medications (any dose):

* Daily use of non-steroidal anti-inflammatory drug (NSAID) \>7 days.
* Antiplatelet therapy.
* Additional antiplatelet therapy (e.g., ticagrelor or similar).
* Anticoagulant(s).
* Systemic steroid(s) \>1 month.

Risk factors:

* History of gastrointestinal ulcer.
* Age ≥75 years.
* Selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) use.
* Severe concomitant disease with increased risk of GI bleeding according to the GP's assessment (e.g., severe liver disease, neoplasia, nicotine or alcohol abuse).

Where this trial is running

Bern and 1 other locations

• Prof. Dr. med. Dr. phil. Sven Streit — Bern, Switzerland (Not_yet_recruiting)
• University of Bern — Bern, Switzerland (Recruiting)

Study contacts

• Principal investigator: Sven Streit, Prof. Dr. med. Dr. phil — University of Bern, Institute of Primary Health Care (BIHAM)
• Study coordinator: Sven Streit, Prof. Dr med. Dr. phil.

Conditions Inappropriate Prescribing; Reflux Disease; Proton Pump Inhibitors; Deprescribing; Proton pump inhibitors