111
RESOLUTION OF PERSISTENT GASTROESOPHAGEAL REFLUX DISEASE (GERD) SYMPTOMS AFTER A CHANGE IN THERAPY: ENCOMPASS - A CLUSTER-RANDOMIZED STUDY IN PRIMARY CARE
D Armstrong1, P Moayyedi1, R Hunt1, Y Lei2, M Bukoski2, R White2
1Division of Gastroenterology, McMaster University, Hamilton; 2AstraZeneca Canada Inc., Mississauga, Ontario
Aims: Many GERD patients have persistent symptoms despite prescription therapy. A prior 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 (Global Overall Symptom [GOS] score), 4 weeks after switching from their current PPI therapy to esomeprazole (E) (Can J Gastro, 2005;19:350-8). We evaluated whether a PASS test-based management strategy of changing GERD therapy would improve GERD symptoms compared with maintaining current therapy.
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 E 20 or 40 mg daily (dosing at physician's discretion) 'I' for 4 weeks. The primary endpoint was the change in GOS score from baseline to 4 weeks; secondary endpoints included freedom from symptoms (GOS, PASS test, RDQ-heartburn [RDQ-HB]). Analysis was carried out at the subject level in those with intention to treat (ITT) data for the primary and secondary endpoints with adjustment for variation attributable to centre, using both mixed effects and multilevel models.
Results: After centre randomization, 973 patients (650 on prior PPIs) were recruited at 136 'I' centres and 591 (362 PPI) at 92 'C' centres; 938/973 (96.4%) 'I' patients received E 40 mg daily (data missing for 4 (0.4%)). The difference in change in GOS scores from baseline to 4 weeks between arms was -0.9 (95% CI: -1.1 to -0.6; p<0.0001) for ITT patients and -0.8 (-1.1 to -0.6; p<0.0001) for evaluable patients on PPIs at baseline. The odds ratio for symptom resolution (PASS) in 'I' patients was 4.0 (95% CI: 2.7 to 6.0; p <0.0001).
Conclusions: After 4 weeks, a change to esomeprazole 20 or 40 mg daily for persistent GERD symptoms identified by the PASS test was associated with a greater improvement in overall symptoms than continuing prior therapy (all or PPI). A greater proportion of patients became symptom free with 'I' than with 'C'.
A PASS test-based management strategy to identify GERD patients with persistent symptoms in primary care and change therapy, leads to symptom resolution in a substantial proportion of patients.