Treatment of patients with heartburn without endoscopic evaluation: on-demand treatment after effective continuous administration of lansoprazole 15 mg.
BACKGROUND
Relapse is frequent after initial treatment for gastro-oesophageal reflux. An alternative strategy to intermittent or continuous therapy may be on-demand treatment.


OBJECTIVE
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.
Bigard
M A
MA
Gastroenterology Unit, University Hospital, Nancy, France. ma.bigard@chu-nancy.fr
Genestin
E
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D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006356:Heartburn / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000031:analogs & derivatives*; D017060:Patient Satisfaction; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D064747:Lansoprazole; D009853:Omeprazole