Healing and recurrence of active duodenal ulcer with nizatidine.
Nizatidine, a new H2-receptor antagonist for treatment of duodenal ulcer disease, was evaluated in a unique two-phase, placebo-controlled, randomized, double-blind, multicenter clinical trial. Patients received either 150 mg nizatidine twice daily or placebo for 4 weeks (phase I). If ulcer healing did not occur during phase I, patients were randomly reallocated to receive either 150 mg nizatidine twice daily or placebo for an additional 4 weeks (phase II). Patients with a healed ulcer continued on the same therapy. All patients were endoscoped at week 8. Healing rates at week 2 were 93 of 265 (35%) nizatidine-treated patients and 55 of 260 (21%) placebo-treated patients (p less than 0.001); at week 4, healing rates were 198 of 259 (76%) nizatidine-treated patients and 95 of 243 (39%) placebo-treated patients (p less than 0.001). In phase II, ulcer healing occurred in 46 of 86 (53%) nizatidine-treated patients and in 23 of 90 (26%) placebo-treated patients (p = 0.002). In patients who had a healed ulcer at previous endoscopies, 18 of 178 (10%) nizatidine-treated patients and 10 of 81 (12%) placebo-treated patients had a recurrence of duodenal ulcer. Smokers who had histories of previous ulcers were more likely to have an early recurrence.
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Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285.
Offen
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Matsumoto
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Chernish
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D000284:Administration, Oral; D000328:Adult; D000428:Alcohol Drinking; D000863:Antacids / Q000627:therapeutic use; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000503:physiopathology; D004724:Endoscopy; D005260:Female; D006635:Histamine H2 Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016567:Nizatidine; D010349:Patient Compliance; D011897:Random Allocation; D012008:Recurrence; D012907:Smoking / Q000009:adverse effects; D013844:Thiazoles / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors
D000863:Antacids; D006635:Histamine H2 Antagonists; D013844:Thiazoles; D016567:Nizatidine