PROGRESSive Withdrawal Esomeprazole and Acid-related Symptoms
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Rebound acid hypersecretion (RAHS), defined as an increase in gastric acid secretion above
pre-treatment levels after PPIs therapy is observed within two weeks after withdrawal of
treatment and could theoretically lead to acid-related symptoms such as heartburn, acid
regurgitation, or dyspepsia that might result in resumption of therapy. A plausible
physiologic theory for the rebound phenomenon suggests that long-term, elevated gastric pH
caused by blockage of the proton-pumps stimulates compensatory gastrin release.
Interestingly, Reimer et al. demonstrated the occurrence of RAHS in healthy volunteers who
had received eight weeks of esomperazole. The clinical symptoms occured in a different
prevalence compared with placebo treated patients at ten weeks after withdrawal and until the
end of the study (twelve weeks). Twenty to twenty-two percent of patients displayed symptoms
ten or twelve weeks after having discontinued PPIs while they occured in 1.7-7% of
placebo-treated patients. Efforts should be pursued to restrict PPI therapy use to patients
likely to benefit from it.
In this context, we propose to investigate the benefit of a progressive decrease in doses of
esomeprazole compared to a sudden discontinuation. This is a randomized, double-blind,
placebo-controlled trial with 156 patients treated by esomeprazole 40mg since four weeks
least, randomized to one week of placebo or one week of esomeprazole 20mg. We want to compare
the prevalence of clinical gastrointestinal symptoms between patients with progressive
discontinuation (one week of esomeprazole, 20mg, then discontinuation) or those with sudden
discontinuation of esomeprazole 40mg.