Original article—alimentary tract
Maintenance of Heartburn Relief After Step-Down From Twice-Daily Proton Pump Inhibitor to Once-Daily Dexlansoprazole Modified Release

https://doi.org/10.1016/j.cgh.2011.11.021Get rights and content

Background & Aims

Many patients with gastroesophageal reflux disease (GERD) take a proton pump inhibitor (PPI) twice daily to control symptoms. Once-daily dexlansoprazole modified release (MR) has a dual-delayed release formulation, making it attractive for step-down management of patients whose symptoms are well controlled on twice-daily PPIs. We investigated whether step-down to once-daily dexlansoprazole controls heartburn in patients with GERD who were receiving twice-daily PPI therapy.

Methods

Patients 18 years and older taking a twice-daily PPI for symptom control were enrolled (n = 178) in a single-blind, multicenter study; 163 patients completed the study and 142 patients met criteria for the efficacy analysis. During the 6-week screening and treatment periods, patients recorded the presence of heartburn symptoms twice daily in electronic diaries. Patients' heartburn was considered well controlled if they had an average of 1 symptom or fewer per week during the last 4 weeks of screening and treatment. After screening, qualified patients were switched to masked dexlansoprazole MR 30 mg and placebo for 6 weeks. The primary efficacy end point was the proportion of patients whose heartburn remained well controlled after step-down. GERD-related symptoms and quality of life (QOL) also were evaluated using the Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) and the PAGI-QOL questionnaires, respectively.

Results

After step-down to once-daily dexlansoprazole MR 30 mg, heartburn remained well controlled in 88% of patients (125 of 142). These patients were able to maintain their GERD-related symptom severity and QOL, indicated by marginal changes in the PAGI-SYM and PAGI-QOL total and subscale scores, respectively.

Conclusions

Most patients with GERD who take twice-daily PPI to control heartburn are able to successfully step down to once-daily dexlansoprazole 30 mg.

Section snippets

Study Design

This multicenter, single-blind study evaluated the efficacy of dexlansoprazole MR 30 mg once daily in maintaining control of heartburn in patients whose heartburn was well controlled on twice-daily PPI. All study sites obtained institutional review board or ethics committee approval before participation and complied with the requirements of the Declaration of Helsinki, the International Conference on Harmonisation, and local regulatory bodies. The study was registered at www.clinicaltrials.gov (

Study Patients

This study was conducted from February 10, 2009, to April 15, 2010, at 45 sites (18 gastroenterology practices). Of 314 patients screened, 178 patients were enrolled and included in the safety analysis. Fifteen patients discontinued prematurely; the most common reasons for discontinuation were AEs (n = 7; 4%) and withdrawn consent (n = 4; 2%). Thus, 163 patients completed the study. Of the 178 enrolled patients, 142 patients met the prespecified criteria for the FAS (Figure 1).

Baseline patient

Discussion

Here we examined the impact of step-down to once-daily dexlansoprazole MR 30 mg in patients with well-controlled heartburn by a twice-daily PPI. Overall, 88% of patients maintained heartburn control after switching, maintaining their GERD-related symptom severity and QOL as indicated by marginal changes in the PAGI-SYM and the PAGI-QOL total and subscale scores. The dual-release formulation of dexlansoprazole MR results in an extended duration of acid suppression,7 which may support successful

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Conflicts of interest The authors disclose the following: Ronnie Fass has served as a consultant or an advisory board member for GlaxoSmithKline, Reckitt Benckiser, Vecta, and Xenoport, has served as a speaker for Takeda and Given Imaging, and has received research funding from AstraZeneca and Wyeth; John Inadomi has served as a speaker, consultant, or an advisory board member for Takeda, AstraZeneca, and Ethicon Endo-Surgery, and has received research funding from BARRX Medical, Inc; Cong Han, Janet O'Neil, and M. Claudia Perez are employees of Takeda Global Research & Development Center, Inc; and Reema Mody is an employee of Takeda Pharmaceuticals International, Inc.

Funding This study (www.clinicaltrials.gov; NCT 00847808) was sponsored by Takeda Global Research & Development Center, Inc, Deerfield, IL. Writing support was provided by Meryl Gersh, PhD, of AlphaBioCom LLC, King of Prussia, PA, and was funded by Takeda Pharmaceuticals, North America, Inc.

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