PEPPER: Determining the optimal strategy for stopping chronic proton pump inhibitor therapy in primary care patients: impact of on-demand use, adjunctive therapies and antacids (KCE-201277)

Summary (Dutch or French)

The stomach is a very acidic environment The gastric acid is produced by glands lining at the gastric wall and it is meant to help digest the ingested food and to protect us from pathogens such as virus and bacteria.

In some cases, the production of gastric acid can be altered and the acidity increased which can lead to injuries at the level of the oesophagus (gastroesophageal reflux disease or GERD) and, stomach and duodenum (gastric or duodenal ulcer).

Proton pump inhibitors (PPIs) is a class of medications that reduce the acid secretion in the stomach. These medications are very effective to relieve symptoms of acid reflux for a well-identified group of diseases and conditions.

Over the years, a major rise in use of these drugs has occurred. Convincing analyses reveal that a large share of this use occurs outside regular indications, at inappropriately elevated doses and prolonged treatment durations. Moreover, there are increasing concerns regarding potential adverse effects and the high cost associated with improper PPI use.

Guidelines propose to reduce chronic use of PPIs, but to date this has not generated a reduction in their application in clinical practice. One reason is the occurrence of a period of 2 weeks of increased acid secretion, with recurrence of symptoms, when these drugs are stopped after already a few weeks of usage (rebound effect). The current recommended strategy is to gradually decrease PPI use, but up to now it has not been shown which would be the best strategy to overcome this period of increased acid secretion and symptoms has not been established.

The PEPPER study (Primary carE PPi dEprescRibing; full title: “Determining the optimal strategy for stopping chronic proton pump inhibitor therapy in primary care patients: impact of on-demand use, adjustment of therapy or discontinuation”) will evaluate two different strategies to overcome the period of increased secretion when trying to interrupt chronic proton pump inhibitor therapy. We will compare the success of stopping PPIs when these strategies are implemented, compared to the current approach of stopping after gradually decreasing (intermittent) PPI intake. The strategies under evaluation are a period of  on-demand(i.e., not daily) PPI use before stopping, or the use of other medications (antiacid so-called alginates)to control gastric acidity and reflux.

We will evaluate the success rate of stopping chronic PPIs treatment with these strategies compared to tapering PPI use. Patients will be followed up for 1 year after interruption of PPIs, and the level of symptom control, quality of life and healthcare costs will be evaluated at intervals.

The study will be conducted in patients from primary care practices with chronic PPIs intake outside of the established disease indications.