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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

By jeremyc | June 4, 2009

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.

Topics: | Nexium |

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