Gastroesophageal refl ux disease is defined as a condition which develops when the reflux of stomach contents causes troublesome symptoms (heartburn, regurgitation) and/ or complications. Reflux disease without reflux-esophagitis or endoscopy-negative reflux disease is defi ned by presence of symptoms and absence of mucosal breaks at endoscopy. In on-demand therapy patients without reflux-esophagitis begin taking esomeprazole on the day they first experience a recurrence of heartburn and then continue to take until symptom relief has been achieved.
AIM. The aim of this multicentre openlabel clinical trial was to evaluate the use and clinical efficacy and safety of on demand therapy in patients without refluxesophagitis.
METHODS. Altogether 929 patients with reflux disease were enrolled at 30 centres in Estonia. Gastroscopy was performed and 805 patients were eligible for participation in the study. The patients used 20 mg esomeprazole for 4 weeks daily and for 12 weeks on-demand. The frequency and severity of heartburn, regurgitation and dysphagia were reassessed after the 4th, the 8th and the 12th weeks of on-demand therapy.
RESULTS. Most of the patients (60–63%) had no heartburn during on-demand therapy. The mean intake of esomeprazole was 2.6 tablets per week. Only 0.7% of the patients discontinued due to insufficient control of heartburn. On-demand therapy with esomeprazole was generally well tolerated overall and adverse events were infrequent and mild.
CONCLUSIONS. On-demand therapy with esomeprazole is effective and well tolerated in maintaining symptom control in patients without reflux-esophagitis.