Famotidine Therapy for Active Duodenal Ulcers

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Abstract
The study objective was to identify factors that influence the rate of healing of duodenal ulcers. A stepwise multivariable statistical analysis of patients with duodenal ulcer was done in a multicenter, prospective, open-label study. Healing was assessed by endoscopy at 4 or 8 weeks. Antacid use and symptoms were recorded in a daily diary. Of 135 patients, ages 19 to 86, 50% had a previous duodenal ulcer, 46.7% smoked, and 34.8% had melena or hematemesis. Famotidine, 40 mg orally was given, at bedtime for 4 or 8 weeks depending on endoscopic evaluation of ulcer healing. Limited antacid use was permitted. The setting was limited to office practices, hospital practices, and university-based medical centers. Multivariable analysis identified five independent predictors present at the time of diagnosis that influenced ulcer healing. The odds of not healing for each risk factor after simultaneous adjustment of the other risk factors were as follows: alcohol use, 6.5 (CI, 2.0 to 20.7, P < 0.002); ulcer size > 10 mm, 4.2 (CI, 1.5 to 11.6, P < 0.005), bleeding symptoms, 3.5 (CI, 1.2 to 10.2, P < 0.03); and a previous duodenal ulcer, 3.1 (CI, 1.05 to 9.0, P < 0.04). The use of salicylates or nonsteroidal antiinflammatory drugs before treatment was associated with an improved odds of healing (adjusted odds ratio, 0.2; CI, 0.1 to 0.9, P < 0.04). The percentage of patients achieving complete ulcer healing after 4 weeks of famotidine decreased inversely with the number of risk factors present, ulcer size, and the quantity of daily alcohol use (P < 0.001). Fewer than half of those patients who still had severe pain at day 7 achieved healing at 4 weeks (P < 0.001). In contrast, smoking and 23 other factors had no statistically discernible effect on ulcer healing with famotidine. Five variables present at the time of diagnosis independently influenced the rate of ulcer healing at 4 weeks: alcohol use, ulcer size, bleeding symptoms, a previous duodenal ulcer, and previous use of salicylates or nonsteroidal anti-inflammatory drugs.