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

Jon Eik Zwisler,Ove B Schaffalitzky De Muckadell,Dorte Ejg Jarbøl,Niels Thorsgaard,Jakob Kragstrup,Annmarie Touborg Lassen

doi:10.1155/2015/175436

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.

Highlights

The use of acid-suppressive medication is rapidly increasing
During the one-year follow-up, six patients were lost to follow-up; no adverse events were seen, except for one patient developing a black discoloration of the tongue during Helicobacter pylori eradication treatment
The present study provides estimates from primary care on the need for continued antisecretory treatment among long-term users

Summary

Introduction

The use of acid-suppressive medication is rapidly increasing. In the western world, proton pump inhibitors (PPIs) are second only to statins in expenditures, and antisecretory medication constitutes a substantial part of the medical budget in the Denmark and other western countries [1,2,3]. Most of the increased use of antisecretory medication is accounted for by long-term users [4, 5]. Antisecretory medication is highly effective for the treatment of peptic ulcer and reflux disease, but it has only sparse effect in the treatment of patients with functional dyspepsia [6]. As no data exist regarding the optimal treatment period, and as there is a poor correlation between initial treatment response and continued effect, some patients might have an unnecessary continued use of antisecretory medication [8]. In a Swedish study, Bjornsson et al [9] found that discontinuation of antisecretory mediation was successful in 27% of long-term users of PPI. Placebo-controlled discontinuation studies of antisecretory medication with interventions carried out in primary care are not yet published

Methods

Results

Conclusion