AstraZeneca announced today that it has completed the Mutual Recognition Procedure in Europe with Sweden as Reference Member State for the use of Nexium® (esomeprazole) to prevent peptic ulcer re-bleeding in adults.1
Nexium® i.v. is the first proton pump inhibitor (PPI) to be indicated in Europe for prevention of re-bleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. The i.v. treatment should be followed by oral acid suppression therapy. Nexium oral also received the indication for prolonged treatment after i.v. induced prevention of re-bleeding peptic ulcers. National approvals will follow throughout 2009.
“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, the current standard treatment for bleeding peptic ulcers with high risk for re-bleeding. Currently, approximately 20% of patients with PUB may experience a re-bleed even after endoscopic treatment2,3 and patients experiencing re-bleeding after initial treatment of PUB have a more than three-fold risk of death.3,4 The approval of Nexium® for preventing peptic ulcer re-bleeding in adults fills a significant gap in current treatment options available to physicians to manage PUB after endoscopic treatment,” said Professor Ernst Kuipers of The Erasmus Medical Centre, Rotterdam.
The application was based on the findings from a large, multinational, randomized, double-blind, placebo-controlled study that was conducted in 16 countries across Europe, Asia and Africa.5 The study population consisted of 767 patients, male and female, aged 18 years or over, who had undergone successful endoscopic haemostatic treatment for PUB. The patients received high doses of i.v. therapy of Nexium® (80mg intravenous bolus infusion for 30 minutes followed by Nexium® 8mg per hour i.v. for 71.5 hours) or matching placebo infusion for 72 hours.5 All patients then additionally received once-daily oral Nexium® 40mg for 27 days.5
Overall, the study showed that Nexium® significantly reduced the number of patients having a re-bleed after initial endoscopic treatment of PUB by almost half. The treatment was found to be more effective within three, seven, and 30 days and significantly reduced the use of hospital resource compared with placebo.5 Nexium® was also considered to be well tolerated with an adverse event profile similar to placebo.5
Until now, no other PPI has demonstrated an overall benefit in high risk peptic ulcer bleeding patients in published international, multi-center studies of PUB in predominantly Caucasian patient populations. 6-11
Nexium® is already approved in Europe for the treatment of heartburn and other symptoms associated with gastroesophageal acid reflux (GERD), for the treatment of reflux esophagitis and for the long-term management of patients with healed esophagitis to prevent relapse. Nexium® is also indicated in the EU for healing of gastric ulcers associated with NSAID therapy and prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk.1 Nexium in combination with an appropriate antibacterial therapeutic regimen is also approved for the eradication of H. pylori and the healing of H. pylori associated duodenal ulcer and the prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers. Nexium i.v. 40 mg powder for injection/infusion as a solution is approved in Europe for gastric antisecretory treatment when the oral route is not possible.
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