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NEXIUM® SETS NEW EFFICACY STANDARD
Head-to-head study confirms Nexium® better than pantoprazole

Prague, Czech Republic, Monday, 27th September 2004 – The superior efficacy of esomeprazole (Nexium®) over pantoprazole was unequivocally demonstrated today when the full results of a head-to-head study were revealed for the first time at the 12th United European Gastroenterology Week (UEGW).

New data from the EXPO study shows that among gastroesophageal reflux disease (GERD) patients with healed erosive esophagitis who were maintained in remission at six months, relapse of esophageal erosions or moderate-severe GERD symptoms was prevented in 16 per cent more patients treated with Nexium® versus pantoprazole. Among patients evaluated in the total management portion of the EXPO study, erosive esophagitis was healed (at four to eight weeks), GERD symptoms were relieved (at four to eight weeks), and both healing and symptom relief were maintained (through six months) in 19 per cent more patients treated with Nexium® than with pantoprazole.

This follows earlier EXPO results in the acute phase of treatment, showing Nexium® achieves higher healing rates and faster symptom resolution versus pantoprazole. , ,

Between 20–40 per cent of people in Europe experience recurrent heartburn, the primary symptom of GERD . The prevalence of erosive esophagitis in patients with GERD is estimated to be approximately 30 per cent, but may be present in 50-65 per cent in selected populations of GERD sufferers. GERD is usually managed in the primary care setting, and estimates suggest that as many as 95 per cent of patients are treated without a prior endoscopy to determine esophageal mucosal disease severity. , , In addition, there is poor correlation between symptom severity and the presence or absence of esophageal erosions or, if present, the severity grade of erosive esophagitis. Thus, symptoms can not be used as diagnostic guidance for predicting disease status of the esophageal mucosa.

Trial lead investigator Dr Joachim Labenz of Jung-Stilling Krankenhaus, Siegen, Germany, said that the excellent efficacy of Nexium® across all grades of esophagitis makes treatment highly predictable, even when treating patients with unknown disease severity.

“Regardless of disease severity, more patients are healed and maintained in remission when treated with esomeprazole, whether you compare it to pantoprazole or lansoprazole,” said Dr Labenz.

“When you add to this data showing esomeprazole offers faster and more sustained symptom relief, it becomes the logical treatment choice.”

In the study, after six months of treatment with Nexium® (20 mg once daily) 87 per cent of patients with healed erosive esophagitis were maintained in remission, compared with 74.9 per cent of those who received pantoprazole (20 mg once daily) (life table estimates p<0.0001).1 Maintenance of healing and symptom relief with Nexium® were significantly greater than with pantoprazole across all grades of erosive esophagitis.1

For the total management of patients with erosive esophagitis, 70.6 per cent of patients were still in remission when initially healed with Nexium®, 40 mg once daily, and then stepped down to maintenance treatment with Nexium®, 20 mg once daily. In contrast, the corresponding figure was 59.4 per cent (crude rates p<0.0001) for patients healed with pantoprazole, 40 mg once daily, and then stepped down to pantoprazole, 20 mg once daily.2

Additionally, significantly more patients taking Nexium® remained free of heartburn symptoms, at both three and six months, than those on pantoprazole (p<0.0001).1

Nexium® is the only proton pump inhibitor (PPI) documented to be better than omeprazole, lansoprazole and pantoprazole in the acute treatment of patients with erosive esophagitis.3, 4, 5, , , , , , The new data, showing the benefits of Nexium® over pantoprazole in long-term treatment, adds to data from previous GERD maintenance studies showing better efficacy with Nexium® over lansoprazole.

Nexium has been shown to provide more effective control of gastric acidity 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. The EXPO study confirms that this superior acid control translates into clinical benefits.1,2,3,4,5 Nexium is only available on prescription. The most common side-effects with Nexium are headache, diarrhoea, and abdominal pain, which occur in around one per cent of patients.

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Notes to editors

EXPO (The Efficacy of Healing and Maintenance Treatment with Esomeprazole and Pantoprazole in Subjects with Reflux Esophagitis) is a head-to-head multinational, multicentre, randomised, double blind management study comparing the efficacy of esomeprazole to pantoprazole in the healing and maintenance treatment of GERD patients with erosive esophagitis. Patients with erosive esophagitis grade A-D, according to the Los Angeles classification system, were randomised to treatment with standard doses of Nexium, 40 mg once daily, or pantoprazole, 40 mg once daily, for four to eight weeks. In the second phase of the study, all asymptomatic patients in whom esophagitis was healed following four to eight weeks acute treatment, were re-randomised to six months treatment with either Nexium, 20 mg once daily, or pantoprazole, 20 mg once daily.

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) as well as the FTSE4Good Index. Nexium is a trade mark of the AstraZeneca group of companies.

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

For further enquiries please contact:
Åsa Pehrsson Mia Ekdahl
Global Product PR Manager, GI Deputy Product PR Manager, GI
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Carrie Monaghan (onsite)
Hill & Knowlton (UK) Ltd
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References:
1. Labenz J, et al. A comparison of esomeprazole and pantoprazole for maintenance treatment of healed erosive esophagitis. Abstract presented at UEGW, Prague, 2004
2. Labenz J, et al. Esomeprazole and pantoprazole: A comparison in the management of patients with erosive esophagitis over acute and maintenance study phases. Abstract presented at UEGW, Prague, 2004
3. Labenz J, et al. Esomeprazole 40 mg heals significantly more helicobacter pylori-negative erosive esophagitis patients than pantoprazole 40 mg. Abstract presented at UEGW, Prague, 2004
4. Labenz J, et al. Analysis of healing associated with 4 weeks’ esomeprazole 40 mg treatment relative to lansoprazole 30 mg and pantoprazole 40 mg with patients across all grades of erosive esophagitis. Abstract presented at UEGW, Prague, 2004
5. Labenz J, et al. Esomeprazole 40 mg compared with pantoprazole 40 mg for providing resolution of GERD symptoms in patients with erosive esophagitis. Abstract presented at UEGW, Prague, 2004
6. Spechler SJ. Epidemiology and natural history of gastro-oesophageal reflux disease. Digestion 1992; 51: S24-9
7. Johnson DA. Evidence-based assessment of the efficacy of esomeprazole for the healing of erosive esophagitis. Expert Rev. Pharmacoeconomics Outcomes Res. 2004; 4(4): 371-82
8. Jones RH, Hungin APS, Phillips J, Mills JG. Gastro-esophageal reflux disease in primary care in Europe: clinical presentation and endoscopic findings. Eur J Gen Pract 1995;1:149-154
9. Carlsson R, et al. International GORD Study Group et al. Gastro-oesophageal reflux disease (GORD) in primary care - an international study of different treatment strategies with omeprazole. Eur J Gastroenterol Hep 1998;10:119-124
10. Johanson J, et al. Prevalence of Erosive Esophagitis (EE) in Patients with Gastroesophageal Reflux Disease (GERD). Gastroenterology 2001;120:A233 (abstr. 1219)
11. Lind T, et al. Esomeprazole provides improved acid control vs omeprazole for patients with symptoms of GERD. Aliment Pharmacol Ther. 2000; 14: 861-7
12. Röhss K, et al. Esomeprazole 40 mg provides more effective acid control than omeprazole 40mg. Am J Gastroenterol 2000; 95: 2432-3
13. Röhss K, et al. Esomeprazole 40mg provides more effective acid control than standard does of all other proton pump inhibitors. Gut 2001; 49 (Suppl III): Abstract 2649
14. Richter JE, et al. Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: a randomised controlled trial. Am J Gastroenterol 2001; 96 (3): 656-65
15. Kahrilas PJ, et al. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: a randomised controlled trial. Aliment Pharmacol Ther. 2000; 14:1249-1258
16. Castell DO, et al. Esomeprazole provides more effective healing than lansoprazole in GERD patients with erosive esophagitis. Gut 2001; 49 (Suppl III): Abstract 3363
17. Lauritsen K, et al. Esomeprazole 20 mg and lansoprazole 15 mg in maintaining healed reflux oesophagitis: Metropole study results. Aliment Pharmacol Ther. 2003 Feb;17 Suppl 1:24; discussion 25-7

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