ESOMEPRAZOLE offers at-risk patients effective protection from nsaid associated ulcers

Main Category: GastroIntestinal / Gastroenterology
Article Date: 11 Jun 2004 - 15:00 PDT

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Data released today demonstrates that esomeprazole (NexiumÒ) is the first proton pump inhibitor (PPI) shown to be effective in the prevention of gastric and duodenal ulcers (GU/DU) associated with the use of all non-steroidal anti-inflammatory drugs (NSAIDs), including cyclo-oxygenase-2- (COX-2) selective NSAIDs.1,2 NexiumÒ has also been shown to be effective in healing GU.1,2

All NSAIDs carry a risk of upper gastrointestinal (GI) side-effects - it has been estimated that 15-25 per cent of NSAID users experience upper GI symptoms3,4,5 and as many as 10-30 per cent of long-term NSAID users develop GU or DU.6 In the UK, NSAIDs cause approximately 3,500 hospitalisations for, and 400 deaths from, ulcer bleeding per annum in those aged 60 years and above.7

The results of a major new pan-European patient survey by the PARE (People with Arthritis / Rheumatism in Europe) Manifesto Steering Group also showed that 35 per cent of people with arthritis / rheumatism experience NSAID-associated upper GI symptoms.8

Professor Neville Yeomans, University of Melbourne, Australia, lead author of one of the studies presented at the European League Against Rheumatism (EULAR) congress, said that effective therapy to treat NSAID-associated upper GI side-effects would help ease the burden to both patients and healthcare professionals.

"NSAID-associated upper GI side-effects, especially ulcers, are a significant problem and not only impair quality of life, but can also result in life-threatening complications, such as bleeding and perforation, and if you prevent ulcers you will prevent the possible complication of ulcers as well," he said.

Effective control of gastric acid secretion is a key factor in the management of NSAID-associated upper GI side-effects. NexiumÒ provides more effective acid control than all other PPIs,9 which in head-to-head comparative trials in gastroesophageal reflux disease (GERD), translates into greater clinical efficacy in the management of GERD.

Prevention of ulcers with Nexium®

In two randomised, controlled, multicentre trials, NexiumÒ significantly reduced the incidence of GU/DU compared with placebo in long-term NSAID users (n = 1,429). Around 95 per cent of patients on NexiumÒ 20 mg (94.8 per cent, p <0.0001) remained ulcer-free over six months' treatment compared with 83 per cent on placebo.1 The effectiveness of NexiumÒ was also apparent in users of COX-2-selective NSAIDs; with 99.1 per cent of patients on the 20 mg dose, remaining ulcer-free (p<0.001), compared with 83.5 per cent on placebo. The data showed one ulcer complication can be avoided by treating nine patients with NexiumÒ for six months.

Effective healing of ulcers with NexiumÒ

Two studies of non-selective and COX-2-selective NSAID-users (n = 809) demonstrated that NexiumÒ is more effective than the H2-receptor antagonist, ranitidine, in healing NSAID-associated gastric ulcers. At eight weeks, 86.6 per cent on 20 mg (once daily) had all ulcers healed, compared with 75.3 per cent on ranitidine 150 mg twice daily (p<0.002).2

Rapid and maintained symptom relief from upper GI symptoms

Further studies, also presented at EULAR, confirm that NexiumÒ is more effective than placebo at providing resolution of heartburn and acid regurgitation after four weeks' treatment10 and maintains improvement in specific dimensions of health-related quality of life and improvement in symptom severity of NSAID-associated upper GI symptoms.11

NexiumÒ is a proton pump inhibitor (PPI) that has been shown to provide more effective control of gastric acid secretion than all other PPIs. 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 GERD. NexiumÒ is only available on prescription. The most common side-effects of NexiumÒ are headache, diarrhoea, and abdominal pain.

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Notes to editors

AstraZeneca submitted a regulatory application to the European Union (EU) in January 2004, for two indications related to the NSAID-associated upper GI symptom programme for NexiumÒ. These indications are for the use of NexiumÒ for the healing of NSAID-associated GU and the prevention of NSAID-associated GU/DU in patients at risk, requiring continued NSAID therapy.

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. NexiumÒ is a trade mark of the AstraZeneca group of companies.

For more information, please visit http://www.astrazenecapressoffice.com,
http://www.patienthealthinternational.com,
http://www.gastrosource.com or
http://www.astrazeneca.com.

For more information on the PARE Manifesto survey, please visit http://www.PAREManifesto.org

For further enquiries please contact:

Louise Marland
Global PR manager
+44 (0)1625 510 782 (direct)
+44 (0)7900 607 794 (mobile)

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

References:

1. Yeomans ND et al. Esomeprazole reduces gastric and duodenal ulcer incidence in at-risk patients taking continuous NSAID therapy. Abstract presented at EULAR, Berlin, Germany 2004.

2. Goldstein JL et al. The comparative healing of gastric ulcers with esomeprazole versus ranitidine in patients taking either continuous COX-2 selective NSAIDs or non-selective NSAIDs. Abstract presented at EULAR, Berlin, Germany 2004.

3. Buttgereit F at al. Gastrointestinal toxic side-effects of nonsteroidal anti-inflammatory drugs and cyclooxygenase-2-specific inhibitors. Am J Med 2001; 110 (Suppl 3A): 13S-19S.

4. Hirschowitz BI. Nonsteroidal anti-inflammatory drugs and the gastrointestinal tract. Gastroenterologist 1994; 2: 207-223.

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

6. Laine L. Non-steroidal anti-inflammatory drug gastroplasty. Gastrointest Endosc Clin N Am 1996; 6: 489-504.

7. 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.

8. People with Arthritis and Rheumatism in Europe (PARE) Manifesto Steering Group. European patient survey 2004. Data on file, PARE.

9. Miner P Jr et al. Gastric acid control with esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole: a five-way crossover study. Am J Gastroenterol 2003; 98(12): 2616-2620.

10. Scheiman JM et al. Esomeprazole resolves heartburn and acid regurgitation in patients taking continuous NSAIDs, including COX-2 selective NSAIDs. Abstract presented at EULAR, Berlin, Germany 2004.

11. Hawkey C et al. Efficacy of esomeprazole for maintenance of symptom relief following initial treatment in patients on long-term NSAID therapy. Abstract presented at EULAR, Berlin, Germany 2004.