According to a Biospace report, Sweden has been approved as Reference Member State for the use of intravenous esomeprazole ( Nexium™) for prevention of re-bleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers in adults. Treatment with intravenous esomeprazole should be followed by oral acid suppression therapy. Oral esomeprazole has also been approved for prolonged treatment after intravenous induced prevention of re-bleeding peptic ulcers. Approvals in other countries are expected to follow throughout 2009.

The licence application was based on evidence from a large, multinational, randomised, double-blind, placebo-controlled study that was conducted in 767 adults who had undergone successful endoscopic haemostatic treatment for peptic ulcer bleeding. Patients were randomised to esopmeprazole (80mg intravenous bolus infusion for 30 minutes followed by esomeprazole 8mg per hour i.v. for 71.5 hours) or matching placebo infusion for 72 hours. All patients then additionally received once-daily oral esomeprazole 40mg for 27 days.

Overall, the study found that esomeprazole reduced the number of patients having a re-bleed after initial endoscopic haemostatic treatment of peptic ulcer bleed by almost half. The treatment was found to be more effective within 3, 7, and 30 days in reducing re-bleeding and reduced the use of hospital resource compared with placebo. Esomeprazole was also considered to be generally well tolerated (no further details available).