title: 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.
authors.affiliation: Gastroenterology Unit, Royal Adelaide Hospital, Australia.
authors.forename: J
authors.initials: J
authors.lastname: Dent
mesh_terms: D001315:Australia; D004334:Drug Administration Schedule; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D006801:Humans; D015993:Life Tables; D009853:Omeprazole / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D009853:Omeprazole