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FDA APPROVES TAGAMET FOR PREVENTION OF UPPER GI BLEEDING IN CRITICALLY ILL (Product Announcement)

 FDA APPROVES TAGAMET FOR PREVENTION OF UPPER GI BLEEDING IN
 CRITICALLY ILL
 NEW ORLEANS, Dec. 9 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approvced Tagamet(R) (cimetidine), administered 50 mg/hour (1200 mg/day) by continuous intravenous infusion, for the prevention of upper gastrointestinal (GI) bleeding in critically ill hospitalized patients, SmithKline Beecham announced today. Tagamet is the first H2 antagonist with this indication.
 For reasons that are not completely clear, critically ill hospitalized patients are at high risk of developing upper gastrointestinal tract damage as a complication of severe illness or traumatic injury. Studies have shown that nearly 90 percent of cardiac surgery patients and up to 100 percent of severe injury patients may suffer some damage to the lining of the upper GI tract. In up to 30 percent of patients, this damage causes clinically significant bleeding that may be fatal. Upper GI bleeding also is common in critically ill patients suffering from shock, infection, burns, and central nervous system injury.
 "This new indication will allow physicians to administer Tagamet prophylactically to prevent the onset of upper GI bleeding in critically ill patients," said David M. Brand, vice president of GI products for SmithKline Beecham Pharmaceuticals.
 A pivotal study demonstrated that Tagamet was significantly superior to placebo in preventing upper GI bleeding in critically ill patients in the intensive care unit (ICU). In the multi-center, placebo-controlled, double-blind study, 131 patients in the ICU were randomized to receive either Tagamet or placebo as a continuous infusion for up to seven days.
 Even though the Tagamet-treated patients were more severely ill at baseline as measured by APACHE II tests (a severity of illness scoring system that has been shown to be predictive of mortality), the incidence of bleeding in the Tagamet group was significantly reduced compared to the placebo group. Only nine of 65 patients (14 percent) treated with Tagamet experienced bleeding, compared to 22 of 66 patients (33 percent) in the placebo group. Bleeding associated with mortality was observed in one of the nine patients receiving Tagamet, compared to four of 22 placebo-treated patients.
 Indeed, the outside medical review committee stopped this trial early because the committee members deemed it unethical to continue to withhold treatment from the control group.
 According to David Peura, M.D., director of clinical services for the division of gastroenterology at the University of Virginia Health Sciences Center, Charlottesville, Va., "The consequences of upper GI bleeding indicate the aggressive treatment to prevent this bleeding is appropriate and should be used early."
 Tagamet, a product of SmithKline Beecham Pharmaceuticals, also is approved to treat gastric and duodenal ulcers, erosive esophagitis (inflamation of the esophagus), and Zollinger-Ellison syndrome (pathological hypersecretory condition).
 -0- 12/9/91
 /CONTACT: Sharyn Arnold, 215-751-7074, or Susan Pruyn, 312-988-2338 or 504-581-1000, both for SmithKline Beecham Pharmaceuticals/
 (SBH) CO: SmithKline Beecham ST: Pennsylvania IN: MTC SU: PDT


GK -- NY001 -- 0386 12/09/91 08:33 EST
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Publication:PR Newswire
Article Type:Product Announcement
Date:Dec 9, 1991
Words:486
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