RISK-FACTORS FOR DELAYED HEALING OF DUODENAL-ULCERS TREATED WITH FAMOTIDINE AND RANITIDINE

Objectives: 1) To validate risk factors for delayed healing of duodena l ulcers identified previously in a pilot study, and 2) To evaluate wh ether famotidine improves the rate of duodenal ulcer healing and pain relief, compared with ranitidine. Methods: Design: prospective, multic enter, double-observer-blinded, randomized trial. Setting: 594 patient s with active duodenal ulcers seen in private practice offices, univer sity based medical practices and Veterans Affairs hospital clinics. In terventions: Patients were randomly assigned to receive famotidine 40 mg or ranitidine 300 mg qhs. Measurements: Endoscopy was performed at entry and at 2, 4, and 8 wk after therapy or until complete ulcer heal ing. Seventeen patient variables, including demographic, past historic al, presenting historical and endoscopic characteristics, were assesse d for their relationship to healing. Results: After 4 wk of treatment, by a ''per protocol'' analysis, three risk factors for nonhealing wer e statistically significant: prior ulcer history [63.0% healed, compar ed to 77.9% with no history, p = 0.001, odds ratio for not healing (OR ) = 2.1, 95% CI = 1.4-3.1]; ulcer size (61.6% of ulcers greater-than-o r-equal-to 10 mm healed at 4 wk compared to 75.5% of smaller ulcers, p = 0.001, OR = 1.9, 95% CI = 1.3-2.8); and smoking (62% of smokers hea led vs. 77.7% of nonsmokers, OR = 2.1, 95% CI = 1.4-3.1). The presence of multiple risk factors resulted in additive risk: for patients with no risk factors, 86.8% healed at 4 wk, with any one risk factor 76.8% healed, with two factors 63.0%, and with all three risk factors only 46.9% healed. Multiple risk factors also affected healing rates at 8 w k. Bleeding, alcohol use, and prior NSAID use did not influence ulcer healing. Although famotidine resulted in statistically significant fas ter ulcer healing when examined on an ''intention-to-treat'' basis, th ere were no differences between the drugs when examined on a ''per pro tocol'' basis. Patients treated with famotidine achieved more rapid pa in relief than those treated with ranitidine. Conclusions: 1) Smoking, prior ulcer history, and ulcer size greater-than-or-equal-to 10 mm ex ert independent risks for nonhealing of duodenal ulcers; 2) These risk s are similar for both famotidine and ranitidine; 3) Patients with mul tiple risk factors for nonhealing may require more prolonged acid supp ression therapy than patients who have no risks.