Placebo-Controlled Discontinuation of Long-Term Acid-Suppressant Therapy: A Randomised Trial in General Practice

Abstract

Objective. To investigate whether patients on long-term antisecretory medication need to continue treatment to control symptoms. Methods. A double-blinded randomised placebo-controlled trial in general practices in Denmark. Patients aged 18–90 who were treated with antisecretory drugs on a long-term basis were randomized to esomeprazole 40 mg or identical placebo. Outcome measures were time to discontinuation with trial medication due to failed symptom control analysed as survival data. The proportion of patients stopping trial medication during the one-year follow-up was estimated. Results. A total of 171 patients were included with a median prior duration of antisecretory treatment of four years (range: 0.5 to 14.6 years). 86 patients received esomeprazole 40 mg and 85 patients received placebo. At 12 months, statistically significantly more patients in the placebo group had discontinued (73% (62/85)) compared with the esomeprazole group (21% (18/86); p < 0.001). Conclusions. Long-term users of antisecretory drugs showed a preference for the active drug compared to placebo. However, 27% of patients continued on placebo throughout the study and did not need to reinstitute usual treatment. One in five patients treated with esomeprazole discontinued trial medication due to unsatisfactory symptom control. Discontinuation of antisecretory treatment should be considered in long-term users of antisecretory drugs. This trial is registered with Trial registration ClinicalTrials.gov ID: NCT00120315.

Use of proton-pump inhibitors among adults: a Danish nationwide drug utilization study

“…Furthermore, up to one third of longterm PPI users have been shown not to have undergone upper endoscopy to confirm presence of erosive esophagitis [Lassen et al 2004], making the indication for long-term treatment doubtful. However, getting such patients off PPI has proven difficult [Batuwitage et al 2007;Reimer and Bytzer, 2010;Ahrens et al 2012;Wermeling et al 2014;Zwisler et al 2015], and this could, at least in part, be a reason for the prevalence of use observed in our study. One possible reason for continuing PPI use in patients without a well established indication could be rebound-acid hypersecretion, that is, acid hypersecretion following withdrawal of PPI therapy.…”

Outcome after Discontinuation of Proton Pump Inhibitors at a Residential Care Site: Quality Improvement Project

“…Finally, the study had a short follow-up period of only 8 weeks. Although previous studies found that asymptomatic patients often experienced heartburn, acid regurgitation, and dyspepsia during the first 4 to 8 weeks after PPI discontinuation, 21,22,24,33 there is a possibility that participants in the current study experienced return of GERD symptoms after the study ended.…”

“…Previous studies, which reported discontinuation success rates of only 14% to 64%, were conducted in primary care or community patients. [21][22][23][24][25] In contrast, the current study focused on a residential care site, and the mean age of the study population was 80 years, older than the mean age in previous studies. Previous studies found that it was easier to discontinue PPIs in older patients because their GERD symptoms were subjectively less severe than those of younger patients.…”

“…Previous literature regarding PPI discontinuation reported success rates of 14% to 64% in community-based patients. [21][22][23][24][25] It is unknown whether PPIs can be safely discontinued in older people without return of gastrointestinal symptoms. Linksy and others 26 performed a retrospective study looking at characteristics of PPI discontinuation in residential care settings, and concluded that many residents can have their PPI therapy discontinued without issues.…”

Effects of discontinuation of chronic medication in primary care: a systematic review of deprescribing trials

“…21 Most studies were conducted in Europe (n = 13) and the US (n = 8), with two studies from Taiwan, one study from Canada, one from Australia, one from Brazil, and one from South Korea. Eleven studies were conducted in general practices or in outpatient clinics, 16,18,[22][23][24][25][26][27][28][29][30] five in nursing homes, 19,[31][32][33][34] three were done in hospitals as well as individual physician practices 17,35,36 and one was conducted in a palliative care setting. 37 The other papers did not specify the setting of the study 20,21,[38][39][40][41] (further details are available from the authors on request).…”