Australian Clinical Trials of Omeprazole in the Management of Reflux Oesophagitis

Abstract

Two multicentre clinical trials of omeprazole in peptic oesophagitis were recently completed in Australia. In the first trial, omeprazole, 20 or 40 mg daily (n = 31), was compared with placebo (n = 32) in 63 patients. After 4 weeks, 81% of the omeprazole-treated patients were healed, as determined endoscopically, compared with 6% of the placebo-treated patients (p less than 0.0001). When the two doses of omeprazole were compared, there was a significant therapeutic advantage for the 40 mg dose at 4 weeks but by 8 weeks there was no significant difference between the two doses. This study included a 6-month surveillance phase in 107 endoscopically healed patients after cessation of omeprazole therapy. By 6 months, erosive or ulcerative oesophagitis had recurred in 82% of these patients. In the second trial, 165 patients with erosive or ulcerative oesophagitis were first healed with omeprazole, 20 mg daily. Of these patients, 159 were then enrolled in a maintenance therapy trial and randomized to three groups: ranitidine, 150 mg b.i.d., omeprazole, 20 mg daily, or omeprazole weekend therapy (i.e. omeprazole, 20 mg daily, on Friday, Saturday and Sunday only). Patients were followed for a maximum period of 12 months or until relapse. Neither ranitidine nor weekend therapy with omeprazole was effective in maintaining patients in remission. However, omeprazole, 20 mg daily, was a highly effective maintenance therapy with 89% of patients in remission after 12 months compared with only 25 and 32% for ranitidine and weekend omeprazole, respectively. All three regimens were well tolerated.