Prevention of Relapse of Reflux Esophagitis after Endoscopic Healing: The Efficacy and Safety of Omeprazole Compared with Ranitidine

Abstract

Ninety-eight patients with erosive and/or ulcerative esophagitis unhealed after at least 3 months' treatment with standard doses of cimetidine (greater than or equal to 1200 mg daily) or ranitidine (greater than or equal to 300 mg daily) were primarily included in an acute healing phase study, and 51 were allocated to 40 mg omeprazole once daily and 47 to 300 mg ranitidine twice daily. After 12 weeks of treatment, 46 (90%) patients given omeprazole were healed, compared with 22 (47%) allocated to ranitidine. Healed patients were then given maintenance treatment with either 20 mg omeprazole once daily or 150 mg ranitidine twice daily for 12 months. Plasma gastrin was determined and gastric mucosal biopsy specimens were obtained during the entire study to assess the structure of the exocrine and endocrine cell populations of the oxyntic mucosa. Sixty-seven per cent of the total number of patients randomized to omeprazole were maintained in clinical and endoscopic remission throughout the 12-month study period as compared with only 10% among those given ranitidine (p less than 0.0001). After 4 weeks of omeprazole treatment basal gastrin levels were slightly increased, with a 95% confidence interval for the change of from 8.6 to 16.9 pmol/l. No further increase in basal gastrin levels was observed during the ensuing study months. No significant histopathologic lesion was found in the oxyntic gland mucosa. In conclusion, omeprazole was far superior to ranitidine in preventing recurrence, a goal achieved without adverse events and significant abnormalities in the oxyntic mucosal exocrine or endocrine cells but with a moderate increase in basal gastrin levels.

One‐year prophylactic efficacy and safety of pantoprazole in controlling gastro‐oesophageal reflux symptoms in patients with healed reflux oesophagitis

“…20 Fifteen patients (7%) withdrew with adverse events over the year, compared to 1±9% reported for ranitidine, 3±5% for omeprazole and 5% for placebo. 13,20,22 For 12 patients (5%) adverse events were serious by the EC de®nition; this compares to 5% for omeprazole and 2% for placebo. 20 For the two serious adverse events for which a relationship to treatment was not excluded by the investigators, the case of colonic polypectomy occurred in a patient with a known history of colon diverticulosis, and the brain tumour was in a patient with existing symptoms at the time of study entry.…”

“…These differences may be due to methodological differences between trials, increasing the apparent rate of relapse for omeprazole: in some cases patients with oesophagitis refractory to treatment with H 2 -antagonists were included; 13,21 in some studies both symptomatic and endoscopic evidence was used to classify relapse; 13,22 and in some trials endoscopies were performed every 3 months, as well as when prompted by clinical symptoms. 13 Median serum gastrin levels approximately doubled from baseline, peaking at 108 ng/L, a little above the upper limit of the normal range for individual gastrin levels in this trial, and reaching a plateau at 6 months. This ®nding is almost identical in pattern and magnitude to that observed with omeprazole.…”

“…This ®nding is almost identical in pattern and magnitude to that observed with omeprazole. 13,23 A rise in serum gastrin levels is to be expected when gastric acid is suppressed by an antisecretory agent. Withdrawal of omeprazole after 4 years of maintenance treatment has been shown to result in prompt normalization of serum gastrin levels.…”

Cost Effectiveness of Medical versus Surgical Treatment in Patients with Severe or Refractory Gastroesophageal Reflux Disease in The Netherlands

“…Four studies months adds up to 1060 months (effectiveness = 88.3%). In were found with follow-up periods ranging from 12 to 36 months (23,(33)(34)(35). Three of them show little variation: 68% the years to follow, patients who respond well to maintenance treatment continue to receive their efficacious dose and are to 73% of patients remained in remission of esophagitis for monitored once a year by means of gastroscopy.…”

Maintenance therapy with cisapride after healing of erosive oesophagitis: a double‐blind placebo‐controlled trial

“…4 To date the best results for maintenance therapy after healing of oesophagitis have been achieved with proton pump inhibitors, which have been reported to reduce relapse rates at 1 year to 10± 30%. 3,5,6 However, although proton pump inhibitors are now accepted as the most effective healing therapy for oesophagitis, concerns remain regarding their safety for long-term maintenance therapy. …”