Study Shows Esomeprazole Reduces Peptic Ulcer Incidence in Patients Taking Low Dose Aspirin
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Study Shows Esomeprazole Reduces Peptic Ulcer Incidence in Patients Taking Low Dose Aspirin

LOS ANGELES, C.A. -- May 23, 2006 -- Results from a new large-scale study, presented at Digestive Disease Week (DDW) today, show that taking Nexium(R) (esomeprazole) in addition to low dose aspirin therapy significantly reduces the incidence of gastric and duodenal ulcers in patients at risk.[1]

Treatment with Nexium(R) resulted in a 70% reduction in ulcer development compared to placebo.

Low dose aspirin is well documented for the primary and secondary prevention of vascular events, mainly myocardial infarction and stroke, and is currently prescribed to approximately 9 million patients in the EU.[2] However, aspirin therapy is also associated with an increased risk of developing gastric and duodenal ulcers [1] and a two - four fold increased risk of upper GI bleeding.[3] These risks are particularly high among certain patient groups, such as the elderly.[4]

The Asterix study -- a randomised, double-blind placebo controlled study in 991 patients -- compared Nexium(R) versus placebo for the prevention of gastric and/or duodenal ulcers in at-risk patients taking low dose aspirin (75 - 325 mg daily). By six months, only 1.8% of patients in the Nexium(R) group had developed a gastric or duodenal ulcer, compared to 6.2% taking placebo (P=0.0007).

Professor Neville Yeomans, Dean of Medicine, University of Western Sydney said this study provides evidence of the potential benefits of co-therapy in at risk patients.

"Although aspirin is valuable for preventing cardiovascular disease, the associated risk of upper GI complications is a real concern for clinicians, even at doses as low as 75mg daily. Studies have already proven that esomeprazole reduces the risk of developing peptic ulcers in patients taking NSAIDs, and these data show that this benefit may also extend to those on aspirin therapy."

Resolution of aspirin-associated upper GI symptoms such as epigastric pain, burning and discomfort, as well as heartburn and bloating, was significantly higher with Nexium(R) than placebo (P<0.05 for all symptoms). Upper GI symptoms have been shown to lead to discontinuation of aspirin medication in a proportion of patients.[5]

About Nexium(R)
Nexium(R) (esomeprazole), a proton pump inhibitor (PPI), works by deactivating the proton pumps that produce stomach acid, reducing the amount of acid that is in the stomach. In the EU, in patients requiring continued NSAID therapy, Nexium(r) is indicated for the healing of gastric ulcers associated with NSAID therapy, and the prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk.

Several comparative clinical trials with more than 15,000 patients with Nexium(R), including the EXPO, the EAZEE and Metropole studies, confirm that Nexium(R) provides superior acid control which translates into clinical benefits.[6], [7],[8],[9],[10],[11] Nexium(r) is only available on prescription.

REFERENCES:
1. Yeomans ND et al. Aliment Pharmacol Ther 2005;22:795-801
2. CHS, National Health and Wellness Survey
3. Weil J et al. BMJ 1995;310:827-30
4. Lanas A et al. New Engl J Med 2000;343:834-9
5. CAPRIE Steering Committee. Lancet 1996;348:1329-39
6. Kahrilas P et al. Aliment Pharmacol Ther 2000; 14:1249-1258
7. Labenz J et al. Aliment Pharmacol Ther 2005; 21:739-746
8. Castell D et al. Am J Gastroenterol 2002; 97:575-83.
9. Lauritsen K et al. Aliment Pharmacol Ther 2003; 17:333-41.
10. Fennerty MB et al. Aliment Pharmacol Ther 2005; 21(4):455-63.
11. Richter J et al. Am J Gastroenterol 2001; 96:656-65.

SOURCE: AstraZeneca

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