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Famotidine Therapy for Active Duodenal Ulcers: A Multivariate Analysis of Factors Affecting Early Healing

James C. Reynolds, MD
[+] Article, Author, and Disclosure Information

Study Centers: Patients were recruited for the study by the following collaborating investigators from the 22 study centers: J.L. Accord, MD, University of Mississippi Medical Center, Jackson, Mississippi; S. Bank, MD and R. Greenberg, MD, SUNY at Stony Brook, Long Island, New York; M.A. Barreiro, MD, SUNY at Binghamton, New York; J.M. Berkowitz, SUNY at Stony Brook, New York; B.I. Bockow, MD, University of Washington School of Medicine, Seattle, Washington; D. Earnest, MD, University of Arizona Health Science Center, Tuscon, Arizona; G. Elta, MD, University Hospital, University of Michigan, Ann Arbor; J.T. Galambos, MD, Grady Hospital, Emory University School of Medicine, Atlanta, Georgia; R.T. Guild, MD, University of Oklahoma Medical Center, Oklahoma City Veterans Administration Medical Center, Oklahoma City, Oklahoma; B.I., Hirschowitz, MD, C. Truss, MD, R. Tobias, MD, M. Go, MD, K. Almodovar, MD, G. Weatherstone, MD, C. Barrier, MD, J. Griffith, MD, R. Pruitt, MD, University of Alabama, Birmingham, Alabama; H.D. Kahn, MD, P.L. Goodman, MD, Medical College of Virginia, Richmond, Virginia; J.W. Longacher, MD, Medical College of Virginia, Richmond, Virginia; J.W. Marks, MD, University of California at Los Angeles, Cedars-Sinai Medical Center, Los Angeles, California; G. McClelland, MD, Louisiana State University School of Medicine, Shreveport, Louisiana; A.J. McCullough, Jr., MD, Case Western Reserve University School of Medicine, Metropolitan Hospital, Cleveland, Ohio; H. Meshkinpour, MD, University of California, Irvine, California; J. Petrini, MD, Cleveland Clinic, Cleveland, Ohio; M. Reichelderfer, MD, University of Wisconsin Center for Health Sciences, Madison, Wisconsin; J.C. Reynolds, MD, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania; W.C. Santangelo, MD, H. Westergaard, MD, University of Texas Health Science Center, Southwestern Medical School, Dallas, Texas; and F.B Thomas, MD, Ohio State University School of Medicine, Columbus, Ohio. These data were presented in part at the annual Digestive Disease Week meetings of the American Gastroenterologic Association, 15 May 1988, in New Orleans, Louisiana.

Grant Support: Supported by a grant from Merck Sharp & Dohme, Inc., West Point, Pennsylvania.

Requests for Reprints: James C. Reynolds, MD, Gastrointestinal Section, 3 Dulles Building, Hospital of the University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104-4283.

Current Author Address: Dr. Reynolds, Gastrointestinal Section, 3 Dulles Building, Hospital of the University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104-4283.

© 1989 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1989;111(1):7-14. doi:10.7326/0003-4819-111-1-7
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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 < 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 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 < 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.

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.





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