PMID- 24118079 OWN - NLM STAT- MEDLINE DCOM- 20140926 LR - 20220410 IS - 1365-2036 (Electronic) IS - 0269-2813 (Linking) VI - 38 IP - 10 DP - 2013 Nov TI - Distinguishing the impact of dexlansoprazole on heartburn vs. regurgitation in patients with gastro-oesophageal reflux disease. PG - 1303-11 LID - 10.1111/apt.12504 [doi] AB - BACKGROUND: Gastro-oesophageal reflux disease (GERD) is characterised by symptomatic heartburn and regurgitation. Treatment with proton pump inhibitors (PPI) effectively decreases heartburn symptoms, but their effects on symptomatic regurgitation are less clear. AIM: To determine the impact of PPI therapy on heartburn and regurgitation severity in patients with either non-erosive GERD (NERD) or erosive oesophagitis (EE). METHODS: Endoscopically-confirmed NERD patients received dexlansoprazole 30 or 60 mg or placebo in a randomised, blinded, 4-week study. Endoscopically-confirmed EE patients received dexlansoprazole 60 mg or lansoprazole 30 mg in two 8-week, randomised, blinded healing studies. The Patient Assessment of Upper Gastrointestinal Symptom Severity questionnaire, which includes a heartburn/regurgitation subscale, was administered to assess symptom severity at baseline, and at weeks 2 and 4 of the NERD study and at weeks 4 and 8 during the EE trials. We defined separate subscales for heartburn and regurgitation for this post-hoc analysis. Among patients with both symptoms at baseline, improvements in individual heartburn and regurgitation subscales along with the original combined heartburn/regurgitation subscale were determined. RESULTS: In the NERD and EE studies, 661 and 1909 patients, respectively, had both heartburn and regurgitation at baseline. NERD patients receiving dexlansoprazole 30 and 60 mg experienced significantly greater improvements in symptom severity for both heartburn and regurgitation compared with placebo. EE patients receiving dexlansoprazole 60 mg had significantly greater improvements in heartburn/regurgitation and heartburn-only subscales at week 4 compared with those receiving lansoprazole. CONCLUSIONS: Dexlansoprazole appears to be effective in improving both heartburn and regurgitation, and this improvement is maintained for the duration of treatment. CI - (c) 2013 John Wiley & Sons Ltd. FAU - Peura, D A AU - Peura DA AD - Department of Gastroenterology & Hepatology, University of Virginia Health Sciences Center, Charlottesville, VA, USA. FAU - Pilmer, B AU - Pilmer B FAU - Hunt, B AU - Hunt B FAU - Mody, R AU - Mody R FAU - Perez, M C AU - Perez MC LA - eng SI - ClinicalTrials.gov/NCT00251693 SI - ClinicalTrials.gov/NCT00251719 SI - ClinicalTrials.gov/NCT00321984 PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130930 PL - England TA - Aliment Pharmacol Ther JT - Alimentary pharmacology & therapeutics JID - 8707234 RN - 0 (Proton Pump Inhibitors) RN - 0K5C5T2QPG (Lansoprazole) RN - UYE4T5I70X (Dexlansoprazole) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Dexlansoprazole/administration & dosage/*therapeutic use MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Esophagitis/drug therapy MH - Female MH - Gastroesophageal Reflux/*drug therapy/physiopathology MH - Heartburn/*drug therapy/etiology MH - Humans MH - Lansoprazole/therapeutic use MH - Male MH - Middle Aged MH - Proton Pump Inhibitors/administration & dosage/*therapeutic use MH - Severity of Illness Index MH - Surveys and Questionnaires MH - Treatment Outcome MH - Young Adult EDAT- 2013/10/15 06:00 MHDA- 2014/09/27 06:00 CRDT- 2013/10/15 06:00 PHST- 2013/04/01 00:00 [received] PHST- 2013/04/21 00:00 [revised] PHST- 2013/08/30 00:00 [revised] PHST- 2013/09/02 00:00 [accepted] PHST- 2013/10/15 06:00 [entrez] PHST- 2013/10/15 06:00 [pubmed] PHST- 2014/09/27 06:00 [medline] AID - 10.1111/apt.12504 [doi] PST - ppublish SO - Aliment Pharmacol Ther. 2013 Nov;38(10):1303-11. doi: 10.1111/apt.12504. Epub 2013 Sep 30.