Omeprazole v ranitidine for prevention of relapse in reflux oesophagitis. A controlled double blind trial of their efficacy and safety.

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 We found that relapse of the disease occurred quite rapidly when treatment was withdrawn with either 20 mg or 40 mg/day of omeprazole.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...

Prognostic factors influencing relapse of oesophagitis during maintenance therapy with antisecretory drugs: a meta‐analysis of long‐term omeprazole trials

“…In addition, an endoscopic examination was performed after 12 months in all patients still remaining in the studies of Dent et al 28 and Hallerba Èck et al 29 …”

“…In individual patients oesophagitis usually relapsed to the same grade or to a lower grade compared to the Table 3. Patient demographics by study Zeitoun et al 25 Staerk Laursen et al 26 Sontag et al 27 Dent et al 28 Hallerba Èck et al 29 initial pre-treatment severity grade. In the omeprazole 20 mg daily group no patient had a more severe endoscopic lesion at relapse, while deterioration of the oesophagitis at relapse was found in one patient in the 10 mg group, ®ve patients in the ranitidine group, nine patients in the omeprazole weekend therapy group, and 11 patients in the placebo group.…”

Effect of omeprazole 10 mg on intragastric pH in three different CYP2C19 genotypes, compared with omeprazole 20 mg and lafutidine 20 mg, a new H2‐receptor antagonist

“…Thus, comparative studies have demonstrated that protonpump inhibitors provided far superior GERD healing compared with histamine H 2 -receptor antagonists (H 2 -RAs). [1][2][3][4][5][6][7][8][9][10][11] In Japan, omeprazole 10 mg, as well as 20 mg, is widely used as maintenance therapy for GERD. Hallerback et al reported that maintenance therapy with omeprazole 10 mg was superior to ranitidine 300 mg 5 .…”

Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease

“…Reduced doses of PPIs have not been shown consistently to be effective long-term in the therapy of GERD. This includes alternate-day omeprazole (84) or so-called weekend therapy (85). A daily dose of 10 mg may be superior to standarddose ranitidine (86).…”