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• W2978071982 abstract "Purpose: Arbaclofen Placarbil (AP) is a novel Transported Prodrug of the reflux inhibitor R-baclofen. The effects of AP on sleep-related symptoms were evaluated as part of a Phase 2 study of AP as treatment for patients with gastroesophageal reflux disease (GERD). Methods: In a double-blind, placebo-controlled study of patients with non-erosive GERD (including LA-A erosive esophagitis), randomization to treatment was stratified based on a history of at least partial symptom response to proton pump inhibitor (PPI) therapy (PPI-responsive, n=98) or no history of taking PPIs (PPI-naive, n=58). Patients discontinued previous GERD therapy except rescue antacids during a 2-week washout, and then were randomized to receive 20 mg QD, 40 mg QD, 60 mg QD, 30 mg BID or placebo for 4 weeks. Patients used an electronic diary to record heartburn (Hb) and regurgitation (Rg) episodes, awakenings during the night due to GERD symptoms, and visual analog scale (VAS) sleep measures from a modified Pittsburgh Sleep Diary. The Epworth Sleepiness Scale was used to assess daytime sleepiness. Results: For PPI-responsive patients, sleep quality improved significantly from baseline to Week 4 for AP at 40 mg QD, 60 mg QD and 30 mg BID compared with placebo (P<0.05). There were no significant differences between AP and placebo observed for change in alertness or daytime sleepiness scores. At week 4 compared with baseline, there was a non-significant trend toward reduced awakenings per week from Hb or Rg at all doses compared with placebo. The percentages of PPI-responsive patients with complete relief of Hb and Rg at week 4 were greater for AP compared with placebo. No significant differences in efficacy endpoints were seen in PPI-naive patients or in the primary analysis of all patients. Only data for PPI-responsive patients are presented (Table).TableConclusion: AP significantly improves sleep quality in PPI-responsive patients possibly by reducing awakenings due to Hb or Rg. Disclosure: Dr Vakil: Consultant, Advisory Committe Member, and Grant/Research Support from XenoPort, Dr Huff: Employee, XenoPort, Ms. Bian - Employee, XenoPort, Dr Jones -Employee, XenoPort, Dr Stamler: Employee, XenoPort. This research was supported by an industry grant from XenoPort, Inc." @default.
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• W2978071982 date "2009-10-01" @default.
• W2978071982 modified "2023-09-26" @default.
• W2978071982 title "Arbaclofen Placarbil Monotherapy Improves Sleep Quality in Patients Who Have Previously Responded to a PPI" @default.
• W2978071982 doi "https://doi.org/10.14309/00000434-200910003-00014" @default.
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