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Previous Volume 338:719-726 March 12, 1998 Number 11 Next

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ABSTRACT

Background Suppressing acid secretion is thought to reduce the risk of ulcers associated with regular use of nonsteroidal antiinflammatory drugs (NSAIDs), but the best means of accomplishing this is uncertain.

Methods We studied 541 patients who required continuous treatment with NSAIDs and who had ulcers or more than 10 erosions in either the stomach or duodenum. Patients were randomly assigned to double-blind treatment with omeprazole, 20 mg or 40 mg orally per day, or ranitidine, 150 mg orally twice a day, for four or eight weeks, depending on when treatment was successful (defined as the resolution of ulcer and the presence of fewer than five erosions in the stomach and fewer than five erosions in the duodenum, and not more than mild dyspepsia). We randomly assigned 432 patients in whom treatment was successful to maintenance treatment with either 20 mg of omeprazole per day or 150 mg of ranitidine twice a day for six months.

Results At eight weeks, treatment was successful in 80 percent (140 of 174) of the patients in the group given 20 mg of omeprazole per day, 79 percent (148 of 187) of those given 40 mg of omeprazole per day, and 63 percent (110 of 174) of those given ranitidine (P<0.001 for the comparison with 20 mg of omeprazole and P = 0.001 for the comparison with 40 mg of omeprazole). The rates of healing of all types of lesions were higher with omeprazole than with ranitidine. During maintenance therapy, the estimated proportion of patients in remission at the end of six months was 72 percent in the omeprazole group and 59 percent in the ranitidine group. The rates of adverse events were similar between groups during both phases. Both medications were well tolerated.

Conclusions In patients who use NSAIDs regularly, omeprazole healed and prevented ulcers more effectively than did ranitidine.

Source Information

From the Department of Medicine, University of Melbourne, Western Hospital, Melbourne, Australia (N.D.Y.); the Second Department of Internal Medicine, Semmelweis University Medical School, Budapest, Hungary (Z.T.); the Second Department of Medicine, Borsod County Teaching Hospital, Miskolc, Hungary (L.J.); the First Department of Medicine, Petz Aladár Teaching County Hospital, Gyor, Hungary (I.R.); the Division of Gastroenterology, Department of Medicine, London Health Sciences, London, Ont., Canada (J.M.H.); the Department of Gastroenterology, Tygerberg Hospital, Tygerberg, South Africa (C.J.R.); and the Department of Rheumatology and Rehabilitation, City Hospital (A.J.S.), and the Division of Gastroenterology, University Hospital (C.J.H.), Nottingham, United Kingdom.

Address reprint requests to Dr. Yeomans at the Department of Medicine, University of Melbourne, Western Hospital, Footscray, Victoria 3011, Australia.

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Therapies for Ulcers Associated with Nonsteroidal Antiinflammatory Drugs
Weilert F., Smith A. C., Stokes P. L., Chan F. K.L., Sung J. J.Y., Guslandi M., DeMarco P. J., Schulman S., Shikhman A. R., Hawkey C. J., Yeomans N. D.
Extract | Full Text  
N Engl J Med 1998; 339:349-351, Jul 30, 1998. Correspondence

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