Skip to content
Home - Media - Press releases - 2003    
21 May 2003
NEW DATA SHOW NEXIUM® RELIEVES NSAID RELATED UPPER GI SYMPTOMS IN PATIENTS WITHOUT ULCERS

AstraZeneca announced today that new data, presented at the annual Digestive Diseases Week Meeting in Orlando, Florida, show that NEXIUM® (esomeprazole) is the first Proton Pump Inhibitor (PPI) proven to significantly relieve upper gastrointestinal (GI) symptoms in non-steroidal anti-inflammatory drug (NSAID) users without ulcers.

“NEXIUM has better acid control than other PPI´s with excellent clinical efficacy, which has brought healing and symptomatic relief from GERD (Gastro Esophageal Reflux Disease) through millions of patient treatments since its launch in 2000. Today’s results clearly show that NEXIUM may also bring clinical benefit to this new patient population,” said Ola Rönn, Vice President and Head, GI Therapy Area, AstraZeneca. “These results are highly important for patients taking NSAIDs, as recent studies have demonstrated that symptomatic NSAID patients have an increased risk of developing upper GI mucosal damage—which can potentially lead to serious medical complications, such as bleeding or perforation, if left untreated.”

Results from two separate studies demonstrated that NEXIUM 20 mg and 40 mg significantly relieved upper GI symptoms associated with NSAID use, as measured by the change in upper mean symptom score compared to placebo* (40 mg: p=0.0003 and p=0.0002; 20 mg: p<0.0001 and p<0.0001). Both doses of NEXIUM also provided significantly faster relief of symptoms. No difference in the incidence of adverse events was observed between placebo and NEXIUM treatment. Additionally, results demonstrated that treatment with NEXIUM improved the quality of life in patients with upper GI symptoms associated with long-term NSAID use, including social functioning, food/drinking problems and sleep dysfunction.

In April of 2003, AstraZeneca applied to the US and EU regulatory authorities for an additional indication for NEXIUM for the treatment of upper GI symptoms in patients taking NSAIDs, based on the data presented today. This is the first of four indications within the NSAID associated GI side effect programme that the company is pursuing for NEXIUM.

The proposed new indications for NSAID-associated conditions are key elements in the life cycle management plan for NEXIUM. It is estimated that approximately 30 million people worldwide take NSAIDs daily, which are accountable for 20-25 per cent of all reported drug related side effects in the UK and US.

Another key study presented at DDW this week confirms that NEXIUM provides the most effective gastric acid suppression compared with all other PPIs, including omeprazole, lansoprazole, pantoprazole and rabeprazole.

In 2002, NEXIUM had sales of $1.978 billion worldwide. 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 top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

Further enquires to:

Media Enquiries

Emily Denney
+44 (0)20 7304 5034

Steve Brown
+44 (0)20 7304 5033

Åsa Pehrsson, Global PR Manager GI, AstraZeneca
+46 (0) 31 706 55 20


Investor Relations

Mina Blair-Robinson
+44 (0)20 7304 5084

Jonathan Hunt
+44 (0)20 7304 5087


Note to News Editors:

  • *In the efficacy study, the primary endpoint was the mean change in the upper GI symptom score – a difference of 0.5 on this scale between active treatment and placebo was considered to be clinically significant. Relief of symptoms was defined as any 7 consecutive days with a diary assessment of ‘none’ or minimal, but with up to 2 days rated as ‘mild’ during the 7-day run-in period.
  • All patients included in the two clinical studies were H. pylori-negative by serology and did not suffer from gastroduodenal ulcers or erosive esophagitis (confirmed by endoscopy). 608 and 556 patients respectively received esomeprazole 40 mg, 20 mg or placebo orally, once daily for 4 weeks.
  • Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used to treat pain and inflammation associated with diseases such as arthritis. Their use is associated with gastro-intestinal side effects such as peptic and duodenal ulceration and upper GI symptoms.
  • Among patients taking traditional NSAIDs or aspirin for conditions such as arthritis, the prevalence rate of erosive esophagitis is more than one in five (21 per cent). It has been estimated that up to 40 per cent of all patients taking NSAIDs experience upper GI side-effects and the annual cost of medical care to treat them is conservatively estimated to exceed US$ 2 billion.
  • To learn more about Nexium®, please visit our interactive website: www.astrazenecapressoffice.com

AstraZeneca websites
Search