Study investigates Nexium® benefits patients with Zollinger-Ellison syndrome

Findings demonstrates Nexium maintained normal acid production in year-long study

Los Angeles, CA - – A new clinical study shows that the proton pump inhibitor (PPI) NEXIUM® (esomeprazole magnesium) maintained normal gastric (stomach) acid levels in patients with Zollinger-Ellison syndrome or idiopathic gastric acid hypersecretion (IGH). Results of the 12-month, multicenter study were presented today at the annual Digestive Disease Week® (DDW®). NEXIUM is indicated for the treatment of GERD and for NSAID-associated gastric ulcers in as-risk patients.

Zollinger-Ellison syndrome (ZES), a rare but serious chronic condition, is characterized by the development of a tumor or tumors that secrete excessive levels of gastrin, a hormone that stimulates acid production by the stomach. ZES is rare, affecting fewer than three out of every million Americans (less than 1,000 people)1, but it is chronic, difficult to treat, and may be life-threatening. Most people with ZES are prone to recurrent gastric and duodenal ulcers; other symptoms include abdominal pain, diarrhea and increased fat in the stools.

Twenty-one patients received one of several doses of NEXIUM, depending on the degree of their acid output and symptoms at various times throughout the trial. The results showed that at 12 months, NEXIUM 40 mg twice daily controlled basal acid output (AO) in 14 study participant (67 percent), NEXIUM 80 mg twice daily was required to control AO in 4 study participants (19 percent), and NEXIUM 80 mg given three times daily maintained AO in 1 study participant. (Adequate acid output control was defined as <5 mmol/h for patients who had prior gastric-acid-reducing surgery, and as <10 mmol/h for patients who hadn't had the surgery.) Further, 18 of 20 patients whose acid was controlled by day 10 maintained control for the duration of the study. No patients showed evidence of erosive esophagitis or gastric or duodenal (located in the upper region of the small intestine) ulcers at 12 months.

"Zollinger-Ellison syndrome places individuals under constant attack from higher than normal amounts of acid that their stomachs produce. Therefore, people with the condition require treatment that can continuously interfere with this faulty mechanism," said lead investigator David Metz, MD, Professor of Medicine, and the Director of the Acid-Peptic Program, Division of Gastroenterology, University of Pennsylvania Health System. "The study shows that NEXIUM provided early and sustained acid suppression to help control symptoms of the disease. These results corroborate previous research on the effectiveness of PPIs in treating gastric acid hypersecretion."

Study Details
The 12-month, open-label trial evaluated the effects of NEXIUM on basal acid output (AO) control in patients with ZES or idiopathic (of unknown cause) gastric acid hypersecretion (IGH). Patients (n=21) being treated with a PPI for ZES (n=19) or IGH (n=2) were switched to NEXIUM 40 mg twice daily (n=19) or NEXIUM 80 mg twice daily (n=2). At baseline and day 10, patients received a gastric analysis (i.e., basal AO test) to measure the amount of acid secreted by the stomach. Patients with controlled AO at day 10 remained on their current dose and were re-tested at three, six and 12 months. In those with uncontrolled acid, doses were titrated up to as high as 240 mg/day until AO was controlled. (Investigators could increase the dose of NEXIUM at their discretion throughout the trial.) Patients underwent an endoscopy at baseline, at six months and at 12 months to check for the presence of gastric or duodenal ulcers and/or erosive esophagitis. NEXIUM was generally well tolerated at all doses.

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About Zollinger-Ellison Syndrome
ZES develops randomly for unknown reasons in most instances. About 25 percent of cases are linked to a genetic syndrome known as multiple endocrine neoplasia type 1 (MEN-1). Nearly half to two-thirds of people with ZES develop cancerous gastrinomas. These tumors generally arise within the pancreas and/or the duodenum, and may spread to the lymph nodes or liver.

About NEXIUM® (esomeprazole magnesium) delayed-release capsules
NEXIUM is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. Most erosions heal in four to eight weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. Symptom relief does not rule out the existence of other serious stomach conditions. NEXIUM also is indicated for reducing the risk of gastric (stomach) ulcers developing among at-risk patients on continuous non-steroidal anti-inflammatory drug (NSAID) therapy. Patients are considered to be at risk if they are 60 and over, or if they have a history of previous stomach ulcer. NEXIUM is not indicated for the treatment of Zollinger-Ellison syndrome.

The most frequently reported adverse events with NEXIUM include headache, diarrhea, and abdominal pain. For full prescribing information for NEXIUM please visit www.nexium-us.com.

About AstraZeneca
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 $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology, and infection products. In the United States, AstraZeneca is a $10.77 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information about AstraZeneca, please visit: www.astrazeneca-us.com.

About Digestive Disease Week®
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 21-25 in Los Angeles. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

1. Estimate derived from U.S. population (300,000,000) and ZES figure (0.1-3 per million of U.S. population) cited in Hirschowitz BI Zollinger Ellison Syndrome: pathogenesis, diagnosis and management. Am J Gastroenterol. 1997 Apr;92(4 Suppl):44S-48S; discussion 49S-50S. (Abstract).
2. Zollinger-Ellison Syndrome. National Organization for Rare Disorders. NORD Web site. Available at: http://www.rarediseases.org/search/rdbdetail_abstract.html?disname=Zollinger%20Ellison%20Syndrome

AstraZeneca funded the study


Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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