New Data of Reducing Gastric and Duodenal Ulcers While Taking Nexium and Aspirin
Gastric or duodenal ulcers and upper gastrointestinal (GI) symptoms are considered to be a common reason for patients taking aspirin to stop their low-dose aspirin therapy for prevention of cardiovascular events, such as myocardial infarction (MI) and ischemic stroke.
New results demonstrated at the Digestive Diseases Week annual meeting (DDW, 30thMay – 4th June, Chicago) showed the ability of Esomeprazole medication to reduce the occurrence of gastric and duodenal ulcers and GI side effects in patients taking low-dose aspirin for risk reduction of adverse CV events.
The OBERON trial realized a double-blind, randomized, prospective analysis of 2426 patients. During the period of 26 weeks the 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 Esomeprazole 40 mg groups respectively (p<0.0001).
James Scheiman, Professor of Gastroenterology, University of Michigan Hospitals, USA, supposed that GI side effects are one of the main reasons that patients stop taking low-dose aspirin. He said that Aspirin prompted dyspeptic symptoms and ulcer risk remain underestimated by the medical community. And according to the OBERON results generic Nexium can reduce ulcers in patients taking cardiovascular doses of aspirin.
The use of low-dose aspirin therapy is prevention of adverse CV events. However, 20% of patients taking low-dose aspirin have gastric or duodenal ulcers. Nexium drug is approved in reduction of the occurrence of gastric ulcers, but 25 % of patients discontinue aspirin intake due to GI side effects. Data show that discontinuation of low-dose aspirin treatment leads to an increased risk of adverse CV events and Esomeprazole tablets 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 of treatment by 80-85%.
Recently a supplemental new drug application (sNDA) for Nexium (esomeprazole magnesium) was submitted to the U.S. Food and Drug Administration (FDA) for the risk reduction of low-dose aspirin-associated gastric and/or duodenal ulcers. Besides AstraZeneca submitted a new product that is supposed to combine low-dose aspirin with Esomeprazole magnesium in a single pill.
