Original article—alimentary tractMaintenance of Heartburn Relief After Step-Down From Twice-Daily Proton Pump Inhibitor to Once-Daily Dexlansoprazole Modified Release
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 Fifteen patients discontinued prematurely; the most common reasons for discontinuation were AEs (n = 7; 4%) and withdrawn consent (n = 4; 2%).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
References (12)
- et al.
Importance of events per independent variable in proportional hazards regression analysisII. Accuracy and precision of regression estimates
J Clin Epidemiol
(1995) - et al.
Step-down from multiple- to single-dose proton pump inhibitors (PPIs): a prospective study of patients with heartburn or acid regurgitation completely relieved with PPIs
Am J Gastroenterol
(2003) Proton pump inhibitor failure–what are the therapeutic options?
Am J Gastroenterol
(2009)- et al.
American Gastroenterological Association medical position statement on the management of gastroesophageal reflux disease
Gastroenterology
(2008) - et al.
Treatment patterns and symptom control in patients with GERD: US community-based survey
Curr Med Res Opin
(2009) - et al.
Overutilization of proton pump inhibitors: a review of cost-effectiveness and risk [corrected]
Am J Gastroenterol
(2009)
Cited by (48)
Good clinical practice recommendations for the diagnosis and treatment of gastroesophageal reflux disease. An expert review from the Asociación Mexicana de Gastroenterología
2024, Revista de Gastroenterologia de MexicoPerception of Proton Pump Inhibitor Side Effects Among Members of the American Broncho-Esophagological Association
2023, Journal of VoiceCitation Excerpt :In this survey study of US-board certified otolaryngologists specialized in adult broncho-esophagology, we found that a majority of responders were concerned about PPI adverse events and had changed their prescribing behavior as a result. De-escalation approaches included avoiding prescribing PPIs altogether, limiting the course, or prescribing H2 blockers instead—all consistent with previously studied PPI deprescribing strategies.28–30 Of note, deprescribing strategies have not been compared head-to-head and no strategy has been demonstrated to be superior.17
Management of Gastroesophageal Reflux Disease
2018, GastroenterologyCitation Excerpt :In a randomized trial of patients with heartburn who did not respond to once-daily lansoprazole (30 mg), patients switched to single-dose esomeprazole (40 mg) had similar proportions of heartburn-free days over an 8-week period as patients receiving twice-daily lansoprazole (30 mg) (54.4% vs 57.5%, respectively).136 In a separate study, 88% of patients receiving twice-daily PPIs (any formulation) could successfully step down to once-daily dexlansoprazole (30 mg).137 Because a growing number of patients are concerned about long-term use of PPIs, physicians can consider adding an alternate antireflux medication to a once-daily PPI.
The Risks and Benefits of Long-term Use of Proton Pump Inhibitors: Expert Review and Best Practice Advice From the American Gastroenterological Association
2017, GastroenterologyCitation Excerpt :The literature regarding PPI reduction is sparse and is almost entirely limited to patients with uncomplicated GERD. Most patients with uncomplicated GERD can be reduced from twice- to once-daily PPIs.70 In one study, a third of patients with uncomplicated GERD alleviated by PPIs were successfully transitioned to H2RAs and an additional 16% were transitioned off all acid suppression.71
In search of the grail: A race for acid suppression
2019, Revista de Gastroenterologia de MexicoThe Effect of Dexlansoprazole on Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis
2024, International Journal of Molecular Sciences
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.