New Study Shows Nexium 40 Mg And 20 Mg Reduced Gastric And Duodenal Ulcers By 80 - 85% In Patients Taking Low-Dose Aspirin For CV Protection

Main Category: GastroIntestinal / Gastroenterology
Article Date: 04 Jun 2009 - 3:00 PDT

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Esomeprazole significantly reduced the occurrence of gastric and duodenal ulcers and upper gastrointestinal (GI) symptoms in patients taking low-dose aspirin for risk reduction of adverse cardiovascular (CV) events[i], such as myocardial infarction (MI) and ischaemic stroke, according to new data presented today at the Digestive Diseases Week annual meeting (DDW, 30thMay - 4th June, Chicago).

GI side effects related to the upper GI tract, which include dyspeptic symptoms with or without development of a gastric or duodenal ulcer, are a common reason for patients discontinuing their low-dose aspirin therapy for prevention of cardiovascular events.[ii],[iii]

The data from the OBERON trial, a double-blind, randomised, prospective analysis of 2426 patients, revealed that esomeprazole 20mg and 40mg reduced the cumulative proportion of patients with peptic ulcers as well as the proportion of patients with gastric or duodenal ulcers when analysed separately after 26 weeks of treatment by 80-85% .i

During the OBERON study period, follow-up endoscopy revealed gastric or duodenal ulcers in 7.4% of patients in the placebo group compared with 1.1% and 1.5 % of those in the esomeprazole 20 mg and 40 mg groups respectively (p<0.0001).

According to James Scheiman, Professor of Gastroenterology, University of Michigan Hospitals, USA, "GI side effects are one of the main reasons that patients stop taking low-dose aspirin. Aspirin induced dyspeptic symptoms and ulcer risk remain underestimated by the medical community. The OBERON results are further evidence that esomeprazole can reduce ulcers in patients taking cardiovascular doses of aspirin -a large population of at risk patients in current clinical practice."

Low-dose aspirin is the mainstay therapy for prevention of adverse CV events such as MI and ischaemic stroke.ii However, 20% of patients on low-dose aspirin are at risk of developing upper GI adverse events such as gastric or duodenal ulcers[iv],[v], and as many as 25% discontinue or reduce aspirin intake due to GI side effects[vi], putting them at increased risk of a potentially fatal CV event. Data show that discontinuation of low-dose aspirin treatment leads to an at least three-fold increased risk of adverse CV events that may occur within 1-2 weeks of cessation of therapy.[vii]

AstraZeneca recently submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a product combining low-dose aspirin with esomeprazole magnesium in a single pill for the risk reduction of low-dose aspirin-associated gastric and duodenal ulcers in patients at risk. A supplemental new drug application (sNDA) for Nexium (esomeprazole magnesium) was also submitted for the risk reduction of low-dose aspirin-associated gastric and/or duodenal ulcers. Nexium is approved for risk reduction of the occurrence of gastric ulcers associated with continuous non-steroidal inflammatory drug (NSAID) therapy in patients at risk of developing gastric ulcers.

About NEXIUM® (esomeprazole magnesium)

In the US Nexium 20 mg is indicated to maintain symptom resolution and healing of EE (controlled studies did not extend beyond 6 months), and for treatment of heartburn and other symptoms associated with GERD. Nexium 40 mg and 20 mg daily are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed erosive esophagitis (EE).

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 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.

About Digestive Diseases Week

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 30 - June 4, 2009, at the McCormick Place, Chicago, IL. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit http://www.ddw.org.

References

[i] Scheiman, J. Prevention of Low-Dose Acetylsalicylic Acid-Associated Gastric/Duodenal Ulcers with Esomeprazole 20mg and 40mg Once Daily in Patients at Increased Risk of Ulcer Development: a Randomised Controlled Trial (OBERON). Data to be presented at Digestive Disease Week 2009. Oral presentation 412.

[ii] Yeomans et al. Efficacy of Esomeprazole (20 mg Once Daily) for Reducing the Risk of Gastroduodenal Ulcers Associated With Continuous Use of Low-Dose Aspirin. Am J Gastroenterol 2008;103:2465-2473

[iii] Dyspeptic symptoms and sleep disturbance; a report from a large observational study in low dose acetylsalicylic acid users. Data to be presented at Digestive Disease Week 2009. Poster T1050

[iv] A Randomised, Blinded, Trial of Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events (CAPRIE), The Lancet, Vol 348, 1996, 1329 - 1339

[v] Thiefin et al. Prevalence and clinical impact of upper gastrointestinal symptoms in patients treated with low dose aspirin. Abstract 1924

[vi] Canadian retrospective cohort study: One year compliance with low-dose ASA therapy was 74.4% (Simpson et al 2003)

[vii] Biondi-Zoccai et al. A systematic review and meta-analysis on the hazards of discontinuing or not adhering to aspirin among 50 279 patients at risk for coronary artery disease. European Heart Journal (2006) 27, 2667-2674

Source
AstraZeneca