J G Hatlebakk1, A Berstad. 1. Medical Department A, Haukeland Sykehus, University of Bergen, Norway.
Abstract
BACKGROUND: In patients with reflux oesophagitis, endoscopic healing and symptom relief are considered important treatment goals in long-term care. AIM: To compare the effect of lansoprazole 15 and 30 mg daily on maintaining endoscopic healing and symptom relief in patients with moderate reflux oesophagitis. PATIENTS AND METHODS: In a single-centre, double-blind randomized clinical trial, 103 patients with grade 1 or 2 reflux oesophagitis who were endoscopically healed and asymptomatic after lansoprazole 30 mg daily for 12 weeks, were randomized to maintenance therapy with either lansoprazole 15 mg or 30 mg o.m. Endoscopy was repeated after 3, 6 and 12 months, and symptom relief assessed after 3, 6, 9 and 12 months. Relapse of oesophagitis or symptoms were considered end-points. RESULTS: After 12 months, 14/50 patients (28%) receiving lansoprazole 15 mg daily had suffered an endoscopic relapse compared to 8/53 patients (15%) treated with lansoprazole 30 mg daily. A life table analysis showed no statistically significant difference between the two groups (P = 0.086). Significantly more patients were kept in complete symptomatic remission in the 30 mg group (P < 0.01). In the 15 mg group, 23/50 (46%) had suffered either an endoscopic or symptomatic relapse on completion of the study, compared to 12/53 (23%) in the 30 mg group. A life table analysis showed this difference to be statistically significant (P = 0.010). Lansoprazole 15 and 30 mg daily were equally well tolerated. CONCLUSION: No statistically significant differences were found in endoscopic relapse rate or occurrence of adverse events, while lansoprazole 30 mg proved superior to 15 mg in maintaining patients in symptomatic relief and combined endoscopic and symptomatic remission.
RCT Entities:
BACKGROUND: In patients with reflux oesophagitis, endoscopic healing and symptom relief are considered important treatment goals in long-term care. AIM: To compare the effect of lansoprazole 15 and 30 mg daily on maintaining endoscopic healing and symptom relief in patients with moderate reflux oesophagitis. PATIENTS AND METHODS: In a single-centre, double-blind randomized clinical trial, 103 patients with grade 1 or 2 reflux oesophagitis who were endoscopically healed and asymptomatic after lansoprazole 30 mg daily for 12 weeks, were randomized to maintenance therapy with either lansoprazole 15 mg or 30 mg o.m. Endoscopy was repeated after 3, 6 and 12 months, and symptom relief assessed after 3, 6, 9 and 12 months. Relapse of oesophagitis or symptoms were considered end-points. RESULTS: After 12 months, 14/50 patients (28%) receiving lansoprazole 15 mg daily had suffered an endoscopic relapse compared to 8/53 patients (15%) treated with lansoprazole 30 mg daily. A life table analysis showed no statistically significant difference between the two groups (P = 0.086). Significantly more patients were kept in complete symptomatic remission in the 30 mg group (P < 0.01). In the 15 mg group, 23/50 (46%) had suffered either an endoscopic or symptomatic relapse on completion of the study, compared to 12/53 (23%) in the 30 mg group. A life table analysis showed this difference to be statistically significant (P = 0.010). Lansoprazole 15 and 30 mg daily were equally well tolerated. CONCLUSION: No statistically significant differences were found in endoscopic relapse rate or occurrence of adverse events, while lansoprazole 30 mg proved superior to 15 mg in maintaining patients in symptomatic relief and combined endoscopic and symptomatic remission.
Authors: Thomas O Kovacs; James W Freston; Marian M Haber; Barbara Hunt; Stuart Atkinson; David A Peura Journal: Dig Dis Sci Date: 2009-03-07 Impact factor: 3.199