Omeprazole and ranitidine in the prevention of relapse in patients with duodenal ulcer disease.

BACKGROUND: Although the eradication of Helicobacter pylori is of primary importance when initiating treatment, it is also important to have a strategy for patients who are H pylori-negative, fail to demonstrate eradication or have a tendency to become re-infected or relapse. PATIENTS AND METHODS: In a double-blind, parallel-group clinical trial of 928 patients (from 70 centres in 16 countries) with duodenal ulcers who after a short term study had relief of symptoms and healed ulcers proved endoscopically, 308 were randomly assigned to receive omeprazole 10 mg in the morning, 308 to receive omeprazole 20 mg in the morning and 312 to receive ranitidine 150 mg at bedtime for up to 12 months. Symptoms were assessed every three months and endoscopy repeated at three, six and 12 months, or more often if indicated by recurrence of symptoms. The safety screening included basal serum gastrin concentrations and gastric mucosal histopathology. RESULTS: The remission rates up to 12 months were 87% for the omeprazole 20 mg group, 71% for the omeprazole 10 mg group and 63% for the ranitidine group. Omeprazole 20 mg differed significantly from both omeprazole 10 mg (P=0.0001, 95% CI 9 to 23) and ranitidine (P=0.0001, 95% CI 17 to 31). There was no statistically significant difference between omeprazole 10 mg and ranitidine over the 12-month period, but the 95% confidence interval allowed differences between 0% and 16% in favour of omeprazole at 12 months. A Cox regression analysis revealed that longer treatment courses to heal, smoking, a long ulcer history and young age negatively contributed to the odds of staying in remission. The treatments were well tolerated. There was a slight increase in basal serum gastrin concentrations, reflecting the different degrees of acid inhibition induced by the three treatments. No dysplastic or neoplastic lesions were found in any biopsies. CONCLUSIONS: More duodenal ulcer patients are maintained in remission with omeprazole 20 mg daily than with omeprazole 10 mg daily or with ranitidine 150 mg at bedtime.

Omeprazole (20 mg daily) versus cimetidine (1200 mg daily) in duodenal ulcer healing and pain relief.

We conducted a double-blind, randomized, parallel group study in 169 patients with acute duodenal ulcers to compare omeprazole, 20 mg daily, with cimetidine, 600 mg twice daily. After 2 wk, 58% of the omeprazole-treated patients and 46% of the cimetidine-treated patients were completely healed (p = 0.056). After 4 and 6 wk 84% and 88% healed with omeprazole, and 80% and 89% healed with cimetidine (p = NS). After 2 wk, pain was completely gone in 62% of the omeprazole-treated patients versus 46% of the cimetidine-treated patients (p = 0.04). Clinical or laboratory adverse events were reported in 6 (7%) of the omeprazole-treated patients and 11 (13%) of the cimetidine-treated patients (p = NS). An adverse event caused withdrawal of 1 patient on omeprazole (anxiety and depression) and 2 patients on cimetidine (diarrhea and fall in hemoglobin). We conclude that omeprazole (20 mg daily) resulted in a trend toward more rapid ulcer healing compared with a relatively high dose of cimetidine (600 mg b.i.d.), and was preferred by patients for relief of ulcer pain.

Cimetidine therapy for gastroesophageal reflux disease.

In a Canadian multicenter trial, a new dosing regimen of cimetidine (Tagamet)-600 mg given twice a day-was compared with the standard regimen of 300 mg four times a day in 118 evaluable patients with endoscopically proved esophagitis. More than 90% of the patients evaluated had clinically moderate to severe esophagitis. After four weeks of therapy, both regimens had significantly reduced the number of episodes and the severity and duration of the worst episodes of daytime and nighttime heartburn, as evaluated by visual analogue scales. After eight weeks of therapy, this improvement persisted. There was no difference between the regimens. Healing was observed endoscopically in 57% of patients receiving cimetidine 300 mg four times a day and in 55% of those receiving 600 mg twice a day. Side effects were infrequent and minor.

Hereditary pancreatitis: report of an affected Canadian kindred and review of the disease.

Hereditary pancreatitis is an autosomal dominant disease with no other known cause. It usually begins in childhood and is characterized by recurrent attacks of abdominal pain of variable intensity and duration, followed by symptom-free periods. The diagnosis is usually made in early adult life, when pancreatic insufficiency and calcifications appear. Complications are less frequent than in nonhereditary chronic pancreatitis. There are also differences between the two forms of chronic pancreatitis in sex incidence, etiologic factors and life expectancy. In a Canadian kindred three generations are affected with hereditary pancreatitis; there are four definite and four suspected cases. More than 40 affected kindreds, including 195 proven cases and 190 suspected cases, have now been reported in the literature. Thus, hereditary pancreatitis should be considered in the differential diagnosis of chronic relapsing pancreatitis of unknown cause as well as recurrent abdominal pain in childhood.