No abstract

The aim of this study was to compare recurrence rates of reflux oesophagitis (after endoscopic healing with omeprazole) over a 12 month period of randomised, double blind, maintenance treatment with either daily omeprazole (20 mg every morning; n=53), weekend omeprazole (20 mg on three consecutive days a week, n=55) or daily ranitidine (150 mg twice daily, n=51). Patients were assessed for relapse by endoscopy (with gastric biopsy) at six and 12 months, or in the event of symptomatic recurrence, and serum gastrin was monitored. At 12 months, the estimated proportions of patients in remission (actuarial life table method) were 89% when receiving daily omeprazole compared with 32% when receiving weekend omeprazole (difference 57%, p<0001, 95% confidence intervals: 42% to 71%) and 25% when receiving daily ranitidine (difference 64%, p<0001, 95% confidence intervals: 50% to 78%). Median gastrin concentrations increased slightly during the healing phase, but remained within the normal range and did not change during maintenance treatment. No significant pathological findings were noted, and no adverse events were attributable to the study treatments. In conclusion, for patients who respond favourably to acute treatment with omeprazole 20 mg every morning, the drug is a safe and highly effective maintenance treatment for preventing relapse of reflux oesophagitis and its associated symptoms over 12 months. By contrast, weekend omeprazole and daily ranitidine were ineffective. (Gut 1994; 35: 590-598) In a recent study of omeprazole in severe reflux oesophagitis,' we showed that omeprazole (20 mg or 40 mg/day) was associated with over 80% healing after four weeks, compared with 6% healing with placebo. As more than 60% of the patients we studied had grade 3 or 4 oesophagitis, these healing rates were unprecedented.In the second part ofour study, we assessed the pattern and rate of possible recurrence. We found that relapse of the disease occurred quite rapidly when treatment was withdrawn with either 20 mg or 40 mg/day of omeprazole. About 80% of the patients had relapsed after six months. Similar relapse rates were seen by Sandmark et al,2 suggesting that reflux oesophagitis is an ongoing disease, which requires continuous treatment to prevent relapses. Omeprazole has a long duration of action,3 and its efficacy as a suppressor of acid secretion increases during the first three to five days of repeat treatment because of an increased bioavailability.4 In view of its pharmacokinetic profile, we were interested to investigate the safety and efficacy of an intermittent dosing schedule for omeprazole (weekend treatment) and to compare it with a daily dosing schedule for omeprazole or ranitidine as maintenance treatment for erosive or ulcerative reflux oesophagitis.After an initial healing phase with omeprazole 20 mg daily, patients were randomly allocated to receive one ofthese three treatment schedules for up to 12 months. They were observed for symptomatic or endoscopic recurrence. In addition to routine safe...