Esomeprazole Offers at Risk Patients Effective Protection from NSAID Associated Ulcers

Main Category: GastroIntestinal / Gastroenterology
Article Date: 27 Sep 2004 - 9:00 PDT

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Prague, Czech Republic, Monday, 27th September 2004, 08.00 CET - Data released today at the 12th United European Gastroenterology Week (UEGW) demonstrates that esomeprazole (Nexium®) is effective in healing gastric ulcers in patients taking non-steroidal anti-inflammatory drugs (NSAIDs), including cyclo-oxygenase-2 (COX-2) selective NSAIDs. In addition, it is proven to be effective in preventing gastric and duodenal ulcers associated with all NSAIDs, including COX-2 selective NSAIDs, in patients at risk. 1 Nexium® is the first proton pump inhibitor (PPI) with data on (COX-2) selective NSAIDs. Nexium® has also been shown to be effective in resolving heartburn and acid regurgitation. 1

All NSAIDs carry a risk of upper gastrointestinal (GI) side-effects - it has been estimated that 15 to 40 per cent of NSAID users experience upper GI symptoms 1,2,3,4and as many as 15 to 30 per cent of long-term NSAID users develop gastric or duodenal ulcers (GU / DU). 1 Each year in the UK alone, ulcer bleeding caused by NSAIDs results in approximately 3,500 hospitalisations, and 400 deaths, in those aged 60 and above. 1

Professor Chris Hawkey, University Hospital, Nottingham, and lead investigator of the worldwide esomeprazole NSAID programme said the results of the research with Nexium® into the treatment of NSAID-associated upper GI side-effects showed that Nexium® is effective in substantially reducing NSAID-associated damage and ulcers.

"The good news is that this innovative research has provided answers to important clinical questions that have not been previously addressed," Professor Hawkey said. "It shows Nexium® 's ability to reduce dyspepsia and ulcers in patients using selective COX-2 NSAIDs, in addition to standard non-selective NSAIDs."

The key to managing NSAID-associated upper GI side-effects is controlling gastric acid secretion. NexiumÒ has been shown to provide more effective control of gastric acid secretion than any other PPI. 1 It works by deactivating the proton (acid) pumps that produce stomach acid. This reduces the amount of acid that is in the stomach, helping to treat heartburn and other symptoms of gastroesophageal reflux disease (GERD). Nexium® is only available on prescription. The most common side-effects with Nexium® are headache, diarrhoea, flatulence, nausea / vomiting, constipation and abdominal pain, which occur in around one per cent of patients.

Prevention of ulcers with Nexium®

In two randomised, controlled, multicentre trials, NexiumÒsignificantly reduced the incidence of gastric and duodenal ulcers compared with placebo in long-term NSAID users (n=1,429). 1 Around 95 per cent of patients on Nexium® (20 mg: 94.8 per cent, 40 mg: 95.4 per cent, p<0.0001) remained ulcer-free over six months' treatment compared with 83 per cent on placebo. The data showed one ulcer complication can be avoided by treating nine patients with esomeprazole for six months and that approximately 12 ulcer cases are avoided for every 100 at-risk patients treated.

Rapid and maintained symptom relief from upper GI symptoms

Long-term continuous use of NSAIDs, including COX-2 selective NSAIDs, is often linked with symptoms of heartburn and acid regurgitation. The clinical development programme also showed that Nexium® was more effective than placebo at providing resolution of heartburn and acid regurgitation for patients taking NSAIDs after four weeks' treatment. 2

Contact information

For further enquiries please contact:

Åsa Pehrsson
Global product PR manager, GI
+46 31 776 5520 (direct)
+46 708 467625 (mobile)

Carrie Monaghan
Hill & Knowlton (UK) Ltd
+44 (0) 20 7413 3788 (direct)
+44 (0) 7764 487 460 (mobile)

:End:

Nexium® is a trade mark of the AstraZeneca group of companies.

Notes to editors

AstraZeneca submitted a regulatory application to the European Union (EU) in January 2004, for two indications related to the non-steroidal anti-inflammatory drugs (NSAID)-associated upper gastrointestinal (GI) programme for Nexium® . These indications are for the use of Nexium® for the healing of NSAID-associated gastric ulcers and prevention of NSAID-associated gastric and duodenal ulcers in patients at risk, requiring continued NSAID therapy. The 16th of September it was announced that the Mutual Recognition Procedure (MRP) for these new indications for Nexium® has been successfully finalised.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

For more information, please visit:

http://www.astrazenecapressoffice.com
http://www.patienthealthinternational.com
http://www.gastrosource.com
http://www.astrazeneca.com

References:

1 Jones R et al. Esomeprazole reduces gastric and duodenal ulcer incidence in at-risk patients taking continuous NSAID treatment. Presented at UEGW 2004; Prague, Czech Republic.

2 Scheiman JM et al. Esomeprazole resolves heartburn and acid regurgitation in patients taking continuous NSAIDs, including COX-2-selective NSAIDs. Presented at UEGW 2004; Prague, Czech Republic.

3 Singh G et al. Gastrointestinal tract complications of nonsteroidal anti-inflammatory drug treatment in rheumatoid arthritis: a prospective observational cohort study. Arch Intern Med 1996; 156: 1530-1536.

4 Hirshowitz BI. Nonsteroidal anti-inflammatory drugs and the gastrointestinal tract. Gastroenterologist 1994;2: 207-23.

5 Langman MJ et al. Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDs. JAMA 1999; 282: 1929-1933.

6 Silverstein FE et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA 2000; 248: 1247-1255.

7 Laine L. Nonsteroidal anti-inflammatory drug gastropathy. Gastrointest Endosc Clin N Am 1996; 6: 489-504.

8 Langman MJS. Ulcer complications associated with anti-inflammatory drug use. What is the extent of the disease burden? Pharmacoepidemiol Drug Safety 2001; 10: 13-19.

9 Miner P et al. Gastric acid control with esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole: a 5-way cross-over study. Am J Gastroenterol 2003; 98: 2616-2620.