Esomeprazole 20 mg maintains symptom control in endoscopy‐negative gastro‐oesophageal reflux disease: a controlled trial of ‘on‐demand’ therapy for 6 months

Abstract

Background: Most patients with gastro‐oesophageal reflux disease (GERD), regardless of endoscopic status, suffer symptomatic relapse within 6 months of stopping acid suppressant therapy. Aim: To assess the efficacy of ‘on‐demand’ treatment of GERD with esomeprazole, the first proton pump inhibitor developed as an optical isomer. Methods: In this multicentre, double‐blind study, 342 endoscopy‐negative GERD patients demonstrating complete resolution of heartburn during the final week of a 4‐week treatment period with esomeprazole 20 mg or omeprazole 20 mg once daily were randomized to receive esomeprazole 20 mg or placebo on demand (maximum of one dose per day) for a further 6 months. Use of rescue antacids was permitted. Results: All 342 patients (191 males), aged 19–79 (mean 49) years, were evaluable in the intention‐to‐treat analysis. The proportion of patients who discontinued treatment due to insufficient control of heartburn was significantly higher among placebo compared to esomeprazole recipients (51% vs. 14%; P < 0.0001). Patients randomized to esomeprazole on‐demand therapy remained in the study longer than those in the placebo group (mean 165 vs. 119 days). Over 50% took the study medication for periods of 1–3 consecutive days (esomeprazole) or 4–13 consecutive days (placebo). Use of antacids was > 2‐fold higher among placebo recipients. The frequency of adverse events was similar in the two groups, when adjusted for time spent in the study, as were the clinical laboratory profiles. Conclusions: On‐demand therapy with esomeprazole 20 mg is effective and well tolerated in maintaining symptom control in endoscopy‐negative GERD.

Esomeprazole regimens for reflux symptoms in Chinese patients with chronic gastritis

“…On-demand treatment may be more acceptable to patients than the requirement to take medication every day on a long-term basis [10] . In placebo-controlled trials, esomeprazole 20 mg on demand has been shown to be effective and well tolerated in the maintenance of symptom control in patients with NERD [18,19] . In the present study, more patients discontinued from the 8-wk than the 2-wk treatment arm, which may have been the result of the different drug exposures in the treatment period and the difference in assigning maintenance/on-demand treatment in both groups.…”

Overview: initial and long‐term management of gastro‐oesophageal reflux disease

“…9 There is increasing support for the on-demand approach as the preferred strategy. [10][11][12] For example, Bardhan et al prospectively enrolled 526 patients and treated them with either an H 2 RA or proton pump inhibitor taken as needed. 10 Approximately 50% of the patients did not need to take any acid-suppressive medication for a minimum of 6 of the 12 months of the study.…”

Analysis of Nonformulary Use of PPIs and Excess Drug Cost in a Veterans Affairs Population

“…5 This definition includes ondemand (intermittent) users of PPI, who on average use 1 tablet or capsule of PPI every 3-4 days, equivalent to at least 120 tablets or capsule per year. 11,12 Because 90-day supplies may be dispensed in the VA clinic pharmacies or by mail order, longterm PPI users in the present study could include patients with as little as 1 dispensing.…”