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IMPROVEMENT IN SLEEP DISTURBANCE IN PATIENTS WITH PERSISTENT GASTROESOPHAGEAL REFLUX DISEASE (GERD) SYMPTOMS AFTER A CHANGE IN THERAPY: ENCOMPASS - A CLUSTER-RANDOMIZED STUDY IN PRIMARY CARE
R Hunt1, D Armstrong1, P Moayyedi1, Y Lei2, M Bukoski2, R White2
1Division of Gastroenterology, McMaster University, Hamilton; 2AstraZeneca Canada Inc., Mississauga, Ontario
Aims: Patients with persistent GERD symptoms often complain of sleep disturbance despite prescription therapy. Previously, a validation study of the PPI Acid Suppression Symptom (PASS) test, (a 5-item, Yes/No questionnaire), identified patients with persistent GERD symptoms, 32% of whom became symptom-free 4 weeks after switching from their current PPI to esomeprazole (Can J Gastro, 2005;19:350-8). We evaluated whether a PASS test-based management strategy of switching GERD therapy to esomeprazole in those with persistent symptoms would improve sleep disturbance in such patients.
Methods: A multi-centre, cluster-randomized, open-label study in primary care physician centres across Canada. Centres were randomized to intervention 'I' or control 'C' arms. After baseline assessment, patients with persistent GERD symptoms (ie PASS test failure) continued current therapy 'C' or switched to esomeprazole 20 or 40 mg daily (dose at physician's discretion) 'I' for 4 weeks. Sleep disturbance, assessed by the PASS test at baseline and 4 weeks, was defined by a "Yes" answer to the question "Is your sleep affected by your stomach symptoms". Intention-to-treat (ITT) analysis was carried out at the subject level with adjustment for variation attributable to centre, using a multilevel model.
Results: After centre randomization, 973 patients (650 on PPIs at baseline) were recruited at 136 'I' centres and 591 (362 PPI) at 92 'C' centres; 938/973 (96.4%) 'I' patients received esomeprazole 40 mg daily (data missing for 4 (0.4%)). Results for patients with sleep disturbance in each group are presented in the table. The odds ratio for persistent sleep disturbance (PASS test) with 'I' compared with 'C' was 0.30 (95% CI: 0.21 to 0.42; p<0.0001), indicating a significant reduction in sleep disturbance following a switch to esomeprazole.
Conclusions: After identifying patients with persistent GERD symptoms using the PASS test, a change in treatment to esomeprazole 20 or 40 mg daily was associated with an improvement in sleep symptoms in more patients than continuing prior therapy.
Sleep disturbance, identified by a simple, validated questionnaire, is common, occurring in about 60% of patients with GERD symptoms despite acid suppression therapy. Significant improvement in sleep disturbance was observed after switching to esomeprazole 20 or 40 mg daily for 4 weeks.
Results: