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| |  Esomeprazole Approved in EU for Prevention of Peptic Ulcer Re-bleeding Following Endoscopy NEW YORK -- May 5, 2009 -- Esomeprazole (Nexium) has been approved in Europe for the prevention of peptic ulcer re-bleeding in adults following therapeutic endoscopy. "Peptic ulcer bleed is a common and potentially life-threatening complication of peptic ulcer disease and until now there has not been an approved pharmacological treatment to reduce the risk of re-bleeding after endoscopic treatment," said Ernst Kuipers, MD, The Erasmus Medical Centre, Rotterdam, the Netherlands. "The approval of [esomeprazole] for preventing peptic ulcer re-bleeding in adults fills a significant gap in current treatment options available to physicians to manage peptic ulcer bleed after endoscopic treatment." The approval was based on the findings from a large, multinational, randomised, double-blind, placebo-controlled study that was conducted in 16 countries across Europe, Asia and Africa. The study population consisted of 767 patients, male and female, aged 18 years or over, who had undergone successful endoscopic haemostatic treatment for peptic ulcer bleed (PUB). The patients received high doses of intravenous (IV) therapy of esomeprazole (80mg IV bolus infusion for 30 minutes followed by esomeprazole 8mg per hour IV for 71.5 hours) or a matching placebo infusion for 72 hours. All patients then additionally received once-daily oral esomeprazole 40mg for 27 days. The treatment was found to be more effective within 3, 7, and 30 days and significantly reduced the use of hospital resource compared with placebo. Esomeprazole was also considered to be well tolerated with an adverse event profile similar to placebo.
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