Famotidine therapy for active duodenal ulcers. A multivariate analysis of factors affecting early healing.

OBJECTIVE

To identify factors that influence the rate of healing of duodenal ulcers.

DESIGN

A stepwise multivariable statistical analysis of patients with duodenal ulcer 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.

SUBJECTS

Of 135 patients, ages 19 to 86, 50% had a previous duodenal ulcer, 46.7% smoked, and 34.8% had melena or hematemesis.

INTERVENTIONS

Famotidine, 40 mg orally, at bedtime for 4 or 8 weeks depending on endoscopic evaluation of ulcer healing. Limited antacid use was permitted.

SETTING

Office practices, hospital practices, and university-based medical centers.

MEASUREMENTS AND MAIN RESULTS

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 less than 0.002); ulcer size greater than 10 mm, 4.2 (CI, 1.5 to 11.6, P less than 0.005), bleeding symptoms. 3.5 (CI, 1.2 to 10.2, P less than 0.03); and a previous duodenal ulcer, 3.1 (CI, 1.05 to 9.0, P less than 0.04). The use of salicylates or nonsteroidal anti-inflammatory drugs before treatment was associated with an improved odds of healing (adjusted odds ratio, 0.2; CI, 0.1 to 0.9, P less than 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 less than 0.001). Fewer than half of those patients who still had severe pain at day 7 achieved healing at 4 weeks (P less than 0.001). In contrast, smoking and 23 other factors had no statistically discernible effect on ulcer healing with famotidine.

CONCLUSIONS

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.