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Superiority of Lansoprazole vs Ranitidine in Healing Nonsteroidal Anti-inflammatory Drug–Associated Gastric Ulcers
Results of a Double-blind, Randomized, Multicenter Study
Naurang M. Agrawal, MD;
Donald R. Campbell, MD;
Michael A. Safdi, MD;
Nancy L. Lukasik, BSN;
Bidan Huang, PhD;
Marian M. Haber, MD;
for the NSAID-Associated Gastric Ulcer Study Group
Arch Intern Med. 2000;160:1455-1461.
Background The usefulness of nonsteroidal anti-inflammatory drugs (NSAIDs) is limited by adverse gastrointestinal tract events.
Objective To identify the optimal antisecretory therapy for healing of gastric ulcer in patients using NSAIDs and the impact of concurrent Helicobacter pylori infection on ulcer healing.
Design Prospective, double-blind, multicenter, parallel-group study.
Setting Gastroenterology practices in ambulatory and referral center settings.
Patients Three hundred fifty-three patients with an active, nonmalignant gastric ulcer at least 5 mm in diameter confirmed by endoscopy and biopsy and who continued to receive stable doses of NSAIDs.
Intervention Patients were randomized to receive ranitidine hydrochloride, 150 mg twice daily, or lansoprazole, 15 mg or 30 mg once daily, for 8 weeks.
Measurements Healing was assessed by endoscopy at 4 and 8 weeks in an intent-to-treat population. Helicobacter pylori status was assessed by histological examination.
Results After 8 weeks of treatment, healing was observed in 61 (53%) of 115, 81 (69%) of 118, and 85 (73%) of 117 patients receiving ranitidine lansoprazole, 15 mg, and lansoprazole, 30 mg, respectively (P<.05 for ranitidine vs both lansoprazole doses; 95% confidence interval, 3.2-28.0 for ranitidine vs lansoprazole, 15 mg, and 7.4-31.8 for ranitidine vs lansoprazole, 30 mg). The gastric ulcer healing rates were similar between H pylori–infected and –noninfected patients, with a statistically significant increase with the use of lansoprazole vs ranitidine.
Conclusions In patients who require continuous treatment with NSAIDs, lansoprazole is superior to ranitidine for healing of NSAID-associated gastric ulcers. Healing is not delayed by the presence of H pylori infection.
From the Department of Medicine, University of Connecticut Health Center, Farmington (Dr Agrawal); Departments of Medicine, Veterans Affairs Medical Centers, Kansas City, Mo (Dr Campbell), and Cincinnati, Ohio (Dr Safdi); TAP Holdings, Deerfiefld, Ill (Ms Lukasik); Abbott Laboratories, Abbott Park, Ill (Dr Huang); and the Department of Pathology and Laboratory Medicine, Allegheny University Hospitals, Hahnemann Division, Philadelphia, Pa (Dr Haber). Dr Agrawal is now with the Division of Gastroenterology, Duke University Medical Center, Durham, NC; Dr Safdi, with Consultants for Clinical Research, Inc, Greater Cincinnati Gastroenterology, Cincinnati.
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