Treatment of patients with heartburn without endoscopic evaluation: on-demand treatment after effective continuous administration of lansoprazole 15 mg.

Author(s): Bigard MA, Genestin E

Affiliation(s): Gastroenterology Unit, University Hospital, Nancy, France. ma.bigard@chu-nancy.fr

Publication date & source: 2005-10-01, Aliment Pharmacol Ther., 22(7):635-43.

Publication type: Multicenter Study; Randomized Controlled Trial

BACKGROUND: Relapse is frequent after initial treatment for gastro-oesophageal reflux. An alternative strategy to intermittent or continuous therapy may be on-demand treatment. AIM: To compare the efficacy and safety of on-demand lansoprazole 15 mg and placebo treatment in patients with gastro-oesophageal reflux. METHODS: This was a multicentre, randomized, double-blind study in two parallel groups of patients. In the acute study phase, all included patients (n = 203) were treated with lansoprazole 15 mg (once per day) for 4 weeks. At week 4, asymptomatic patients entered the 6-month, on-demand, follow-up phase and were randomized to receive either lansoprazole 15 mg (once per day) or placebo. RESULTS: A higher percentage of patients in the lansoprazole group completed the 6-month follow-up than in the placebo group [81% vs. 61% (P = 0.003)]. Only 16% of patients in the lansoprazole group discontinued the study for insufficient control of heartburn vs. 28% in the placebo group (P = 0.046). The mean daily intake in patients who completed the study was 1-5 capsules/day in the lansoprazole 15 mg group. CONCLUSIONS: On-demand treatment with lansoprazole 15 mg in symptomatic patients after short-term, continuous treatment is a promising therapeutic alternative to intermittent and continuous treatment to maintain heartburn control in patients with gastro-oesophageal reflux.