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Head-to-head trial reveals faster healing across all grades of disease

Mölndal, Sweden, 17 May 2004 - New data released today reveals that esomeprazole (NEXIUM) offers significantly more effective healing in Helicobacter pylori (Hp)-negative patients with erosive esophagitis compared with pantoprazole.1

Speaking at the Digestive Diseases Week (DDW) congress, lead author Dr Joachim Labenz of Jung-Stilling Krankenhaus, Siegen, Germany, said the results of the study were good news for Hp-negative patients suffering from erosive esophagitis, which represent the majority of patients presenting in clinical practice in the western world.

“This analysis shows, regardless of disease severity, esomeprazole is an effective treatment option for these patients, offering significant healing benefits over pantoprazole,” he said.

This post hoc analysis of the Hp-negative patients enrolled in the EXPO study was undertaken because of reports that Hp-status might affect healing of the underlying esophagitis,2 and because the prevalence of Hp infection has decreased over recent years. In addition there are ‘test-and treat’ clinical strategies that call for eradication of Hp infection if and when it is detected. Interim results from EXPO have already shown more effective healing with esomeprazole compared with pantoprazole in the overall study population (with both Hp-positive and Hp-negative patients).3

Consistently greater efficacy of esomeprazole
As expected, Hp-negative patients represent the majority (69.2 per cent, n = 2,186) of the EXPO cohort. The analysis revealed that esomeprazole 40 mg provided better, faster healing in Hp-negative patients with erosive esophagitis compared with pantoprazole 40 mg. Across all Los Angeles (LA) disease severity grades, 79.0 per cent of esomeprazole patients were healed at four weeks, compared with 71.6 per cent of patients on pantoprazole (p <0.0001). This statistically significant difference in favour of esomeprazole persisted also at 8 weeks (p<0.001).

In patients with severe disease (LA grades C and D), the greater efficacy of esomeprazole was even more apparent, with 71.7 per cent healed at four weeks, compared with only 54.9 per cent with pantoprazole (p <0.0001) while at 8 weeks, 89.6 per cent were healed with esomeprazole, compared with 79.7 per cent with pantoprazole (p <0.01).

Overall, esomeprazole 40 mg provided significantly better efficacy at all time-points, and in patients with all grades of disease at baseline, compared with pantoprazole 40 mg (p <0.05).

NEXIUM 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 gastroesophageal reflux disease. NEXIUM is only available on prescription. The most common side-effects of NEXIUM are headache, diarrhoea, and abdominal pain.

1. Labenz et al. Esomeprazole 40 mg heals significantly more Helicobacter pylori-negative erosive esophagitis patients than pantoprazole 40 mg. Poster presented at Digestive Diseases Week congress, New Orleans, 2004.
2. Holtman et al. Gastric Helicobacter pylori infection accelerates healing of reflux esophagitis during treatment with the proton pump inhibitor pantoprazole. Gastroenterology 1999; 117 (1): 11–16.
3. Labenz et al. A comparison of esomeprazole 40mg once-daily and pantoprazole 40mg once-daily for the healing of reflux oesophagitis. Gut 2003; 52 (Suppl VI) A241.

Notes to Editors:
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 15-20, 2004 in New Orleans, Louisiana. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

EXPO background: EXPO (full name: The Efficacy of Healing and Maintenance Treatment with Esomeprazole and Pantoprazole in Subjects with Reflux Espohagitis) is a multi-centre, randomised, double-blind study of 3,161 patients with endoscopically-confirmed erosive esophagitis. Patients Hp status was confirmed at baseline. The healing phase of the study involved 4–8 weeks’ treatment with either esomeprazole 40 mg or pantoprazole 40 mg once daily. All endoscopically-confirmed healed patients entered a six-month maintenance phase. Results from EXPO presented at The 11th United European Gastroenterology Week congress 2003 showed more effective healing at four weeks with esomeprazole compared with pantoprazole in the overall study population (80.9 per cent versus 74.5 per cent, p <0.0001).3

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.

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