Risk factors for delayed healing of duodenal ulcers treated with famotidine and ranitidine.

OBJECTIVES

1. To validate risk factors for delayed healing of duodenal ulcers identified previously in a pilot study, and 2) To evaluate whether famotidine improves the rate of duodenal ulcer healing and pain relief, compared with ranitidine.

DESIGN

prospective, multicenter, double-observer-blinded, randomized trial.

SETTING

594 patients with active duodenal ulcers seen in private practice offices, university based medical practices and Veterans Affairs hospital clinics.

INTERVENTIONS

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 healing. Seventeen patient variables, including demographic, past historical, presenting historical and endoscopic characteristics, were assessed for their relationship to healing.

RESULTS

After 4 wk of treatment, by a "per protocol" analysis, three risk factors for nonhealing were statistically significant: prior ulcer history [63.0% healed, compared 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 > or = 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 healed 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 wk. Bleeding, alcohol use, and prior NSAID use did not influence ulcer healing. Although famotidine resulted in statistically significant faster ulcer healing when examined on an "intention-to-treat" basis, there were no differences between the drugs when examined on a "per protocol" basis. Patients treated with famotidine achieved more rapid pain relief than those treated with ranitidine.

CONCLUSIONS

1. Smoking, prior ulcer history, and ulcer size > or = 10 mm exert independent risks for nonhealing of duodenal ulcers; 2) These risks are similar for both famotidine and ranitidine; 3) Patients with multiple risk factors for nonhealing may require more prolonged acid suppression therapy than patients who have no risks.