Maintenance of Heartburn Symptom Relief in Patients Stepped-Down from Twice-Daily Proton Pump Inhibitor to Once-Daily Dexlansoprazole MR: 13
Abstract
Purpose: To evaluate maintenance of heartburn symptom control in gastroesophageal reflux disease (GERD) patients requiring BID proton pump inhibitor (PPI) therapy who are stepped-down to QD dexlansoprazole MR (DEX) 30 mg. Methods: GERD patients ≥18 yrs of age who required BID PPI for symptom control as determined by their treating physician were enrolled in this singleblinded, multicenter study. During both the 6-week screening and 6-week treatment periods, patients recorded the presence of heartburn symptoms in a daily electronic diary. Patients were considered well-controlled if they experienced an average of ≤1 heartburn episode per week in the last 4 weeks of screening and treatment period. After screening, patients well-controlled on BID PPI were switched to receive masked DEX in the morning and masked placebo in the evening for 6 weeks. GERD-related symptoms and quality of life (QOL) were also evaluated with PAGI-SYM and PAGI-QOL questionnaires, respectively. Adverse events (AEs) were recorded at each visit. The primary endpoint was the percentage of patients who remained well-controlled after switching from BID PPI to QD DEX 30 mg. The secondary endpoint was the change from baseline (CFB) to Final Visit in each subscale and total PAGIQOL and PAGI-SYM scores for patients who continued to be well-controlled after change in therapy. Results: Of 178 patients enrolled who received ≥1 dose of study drug, 163 completed the study and 142 met criteria for efficacy analysis.…
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