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Background: There are few therapeutic options for the prevention of gastrointestinal mucosal damage caused by low-dose aspirin. We therefore investigated the efficacy of famotidine, a well-tolerated histamine H(2)-receptor antagonist, in the prevention of peptic ulcers and erosive oesophagitis in patients receiving low-dose aspirin for vascular protection., Methods: Adult patients (aged >/=18 years) from the cardiovascular, cerebrovascular, and diabetes clinics at Crosshouse Hospital, Kilmarnock, UK, were eligible for enrolment in this phase III, randomised, double-blind, placebo-controlled trial if they were taking aspirin 75-325 mg per day with or without other cardioprotective drugs. Patients without ulcers or erosive oesophagitis on endoscopy at baseline were randomly assigned by computer-generated randomisation sequence to receive famotidine 20 mg twice daily (n=204) or placebo twice daily (n=200). Patients had a final endoscopic examination at 12 weeks. The primary endpoint was the development of new ulcers in the stomach or duodenum or erosive oesophagitis at 12 weeks after randomisation. Analysis was by intention to treat, including all randomised patients who received at least one dose of study drug (famotidine or placebo). This trial is registered as an International Standard Randomised Clinical Trial, number ISRCTN96975557., Findings: All randomised patients received at least one dose and were included in the ITT population. 82 patients (famotidine, n=33; placebo, n=49) did not have the final endoscopic examination and were assumed to have had normal findings; the main reason for participant withdrawal was refusal to continue. At 12 weeks, comparing patients assigned to famotidine with patients assigned to placebo, gastric ulcers had developed in seven (3.4%) of 204 patients compared with 30 (15.0%) of 200 patients (odds ratio [OR] 0.20, 95% CI 0.09-0.47; p=0.0002); duodenal ulcers had developed in one (0.5%) patient compared with 17 (8.5%; OR 0.05, 0.01-0.40; p=0.0045); and erosive oesophagitis in nine (4.4%) compared with 38 (19.0%; OR 0.20, 0.09-0.42; p<0.0001), respectively. There were fewer adverse events in the famotidine group than in the placebo group (nine vs 15); four patients in the placebo group were admitted to hospital with upper gastrointestinal haemorrhage. The other most common adverse event was angina (famotidine, n=2; placebo, n=4)., Interpretation: Famotidine is effective in the prevention of gastric and duodenal ulcers, and erosive oesophagitis in patients taking low-dose aspirin. These findings widen the therapeutic options for the prevention of gastrointestinal damage in patients needing vascular protection., Funding: Merck Laboratories and Astellas Pharma.

Given the range of causes of upper gastrointestinal disease (UGD), the evolving role of Helicobacter pylori in its pathogenesis and the variety of treatments available, one might expect complex management strategies in the management of these diseases. The aim of this study was to determine the current management strategies used in peptic ulcer disease and gastritis in Scotland and to identify areas where large and clinically important variations in practice exist between gastro-intestinal specialists. Between June and September 1994, 130 gastro-intestinal physicians and surgeons were sent a postal questionnaire based on their response to four hypothetical clinical scenarios. Eighty-one (63%) correspondents returned completed questionnaires. The case histories related to: bleeding duodenal ulcer; peptic ulceration whilst taking non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids; management of dyspepsia in the young; and management of gastritis. Thirty-eight per cent of clinicians surveyed advocated the use of intravenous acid reducing agents in peptic ulcer bleeding. A total of 88% advocated endoscopic therapy in the presence of stigmata of recent haemorrhage and 5% suggested a follow up of endoscopy to confirm healing after ulcer bleeding. In treating the patient with ulcer while on NSAIDs, 45% of clinicians would use H2 receptor antagonists, 37% would use omeprazole, 14% misoprostol and 4% helicobacter eradication. Of the clinicians surveyed, 63% said they would investigate a 25-year-old patient with dyspepsia by endoscopy and 84% of these will biopsy for H. pylori. Empirical treatment was favoured by 37% and 4% considered a barium meal. There was no consensus in the treatment of gastritis. There exists considerable divergence of opinion between clinicians in investigation and treatment of upper gastrointestinal disease. The role of endoscopy, the type and duration of medical treatment of bleeding and non bleeding ulcer and gastritis require further, more detailed investigation. A consensus document would be warmly welcomed.