In a large scale investigational study, more than 700 patients received oral esomeprazole following the i.v. course of either esomeprazole or placebo. To date, no other proton pump inhibitor (PPI) has demonstrated an overall benefit in high risk peptic ulcer bleeding patients in international, multicentre trials of predominantly Caucasian patient populations. Peptic ulcers are typically caused by infection with Helicobacter pylori or the long-term use of medicines such as non-steroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin. , If after treatment, a peptic ulcer re-bleeds there is an increased risk of morbidity and mortality and associated healthcare costs.
The results of the Esomeprazole PUB Study demonstrated that significantly fewer patients treated with esomeprazole experienced ulcer re-bleeding compared with placebo at 72 hours (5.9% versus 10.3%, P=0.026) and seven days (7.2% versus 12.9%, P=0.0096). The study also examined sustainability of treatment effect with esomeprazole, which was shown to reduce the number of patients re-bleeding by almost half compared to placebo (7.7% versus 13.6%, P=0.0092) over a 30 day period.
In all cases, patients receiving esomeprazole in the study required significantly fewer interventions by day 30, with 6.4% needing endoscopic retreatment compared with 11.6% in the placebo group.3 In addition, 589 units of blood in the esomeprazole treatment group were transfused to patients compared with 935 units in total in the placebo group.3 Numerically fewer patients required surgical intervention compared to the placebo group. Overall, esomeprazole patients required significantly fewer days in hospital due to re-bleeding compared to the placebo group (284 days versus 500 days, P=0.008).3
“This is a very important study for physicians and patients, as it not only demonstrates how ulcer re-bleeding after endoscopic treatment can be better controlled, but also provides a high level of reassurance in an at-risk population where needs are currently unmet” said Professor Joseph Sung, Institute of Digestive Diseases/Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, China.
Professor Sung continued “To date, successful studies in this area have not focused on populations from such wide geography and ethnic backgrounds, or indeed followed outcomes for 30 days – the time period in which the problems associated with the recurrence of bleeding can be most acute. This helps us learn a great deal about the clinical outcomes that should be targeted in the management of peptic ulcer bleed moving forward”
Professor Alan Barkun, Professor and Director, Division of Gastroenterology, McGill University, Montreal, Quebec, Canada commented, “The results of the PUB study should bring about a step-change in clinical practice as they demonstrate how re-bleeding can be prevented in a diverse population, and also point to the potential for cost savings through reduced repeat endoscopic treatment and transfusion. This is important in terms of patient outcomes and will also be of interest to healthcare budget holders.”
In the Esomeprazole PUB Study,1,2,3,4 767 patients from 16 countries across Europe, Africa and Asia,9 who had received successful endoscopic treatment for PUB were randomized to first receive an i.v. infusion of esomeprazole 80mg over 30 minutes followed by 8mg i.v./hour for 72 hours, and then receive 40mg oral treatment for 27 days.9 A parallel placebo controlled group received an i.v. infusion of placebo before the same 27 day period of oral treatment with esomeprazole.
The PUB study was supported by AstraZeneca. AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. PUB
• Peptic Ulcer Bleeding (PUB) is a potentially life-threatening event that occurs as a complication of peptic ulcer diseasePUB
• PUB occurs when the ulcer erodes into an underlying blood vessel. The resulting blood loss can be significant as clotting can be impaired in the acidic environment. If after treatment, a peptic ulcer re-bleeds there is an increased risk of morbidity and mortality9,12,13 and associated healthcare costs13,14,15,16 Nexium® (esomeprazole)
• Nexium® is not yet approved for management of Peptic Ulcer Bleeding
• Nexium® is approved in Europe for indication in adults for treating frequent, persistent heartburn and other symptoms associated with acid reflux (GERD) and for the healing and maintenance of healing of erosive esophagitis . Nexium® is also approved in the short-term treatment of GERD in children aged 1-17 years
• Nexium® is 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.17 Nexium® is also indicated for healing of Helicobacter pylori associated duodenal ulcers and prevention of peptic ulcers relapse in patients with Helicobacter pylori associated ulcers17
About United European Gastroenterology Week (UEGW)
The United European Gastroenterology Federation, with the active involvement of all member societies, produces a unique annual meeting to learn about the latest advances in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. UEGW 2008 is in Vienna from the 18th-22nd October
