title: Maintenance of heartburn relief after step-down from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release.
abstract: OBJECTIVE
  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.
authors.affiliation: Section of Gastroenterology, Southern Arizona VA Healthcare System, Tucson, Arizona 85723, USA. ronnie.fass@med.va.gov
authors.forename: Ronnie
authors.initials: R
authors.lastname: Fass
authors.forename: John
authors.initials: J
authors.lastname: Inadomi
authors.forename: Cong
authors.initials: C
authors.lastname: Han
authors.forename: Reema
authors.initials: R
authors.lastname: Mody
authors.forename: Janet
authors.initials: J
authors.lastname: O'Neil
authors.forename: M Claudia
authors.initials: MC
authors.lastname: Perez
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage* / Q000493:pharmacokinetics; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D064748:Dexlansoprazole; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications* / Q000473:pathology; D006356:Heartburn / Q000188:drug therapy*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000008:administration & dosage* / Q000493:pharmacokinetics; D011788:Quality of Life; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D064748:Dexlansoprazole