WASHINGTON, May 22, 2007 /PRNewswire-FirstCall/ -- AstraZeneca will present several studies today regarding pediatric patients with gastroesophageal reflux disease (GERD) during oral and poster sessions at the annual Digestive Disease Week meeting held at the Washington Convention Center.
The studies being presented further support AstraZeneca's commitment to research in the area of gastrointestinal health among the pediatric population. NEXIUM (esomeprazole magnesium) received approval in April 2006 for the short-term treatment (up to 8 weeks) of GERD in adolescent patients aged 12 to 17. The approval is supported by extrapolation of results from adequate and well-controlled studies that supported the approval of NEXIUM for adults, and safety and pharmacokinetic studies performed in adolescent patients. The safety and effectiveness of NEXIUM for the treatment of symptomatic GERD in patients less than 12 years of age and for other pediatric uses have not been established.
The exact prevalence of GERD in children is unknown. However, GERD can lead to potentially serious complications like failure to thrive and erosive esophagitis in children. There are very few studies in the medical literature reporting the frequency of GERD symptoms in children. One such study, a practice-based survey looked at the prevalence of GERD symptoms in 3-17 year old children. The study included 566 parents of otherwise healthy 3-9 year old children and revealed that symptoms of GERD (heartburn, epigastric pain and regurgitation) were reported weekly in 2-8%, which is not that uncommon.
"GERD, which can potentially lead to more serious conditions, not only impacts adults but it is also common in childhood," said Marta Illueca, MD, F.A.A.P., Director, Clinical Research, GI Respiratory, AstraZeneca. "With patient health being our priority, one of our object ives is to better understand pediatric GERD and how to treat the younger population affected by this chronic but treatable disease."
The three studies to be presented and discussed at the meeting include:
Healing of Erosive Esophagitis (EE) and Improvement in Symptoms of Gastroesophageal Reflux Disease (GERD) in 1- and 2-Year-Old Children after Esomeprazole Treatment
Oral Presentation, Tuesday, May 22, 2007, 11:18 AM
150AB, Washington Convention Center
Effect of Esomeprazole on Gastroesophageal Reflux Measured by 24-hour pH- Impedance Monitoring in Preterm Infants and Neonates with Pathological Acid Gastroesophageal Reflux
Poster Presentation, Tuesday, May 22, 8:00 AM
Hall E, Washington Convention Center
Acid-suppressive Effects and Pharmacokinetics After 7 days Repeated Once-daily Dosing of Esomeprazole in Preterm Infants and Neonates with Pathological Acid Gastroesophageal Reflux
Poster Presentation, Tuesday, May 22, 8:00 AM Hall E, Washington Convention Center
About NEXIUM(R) (esomeprazole magnesium)
NEXIUM is approved for the treatment of heartburn and other symptoms associated with GERD, as well as for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4-8 weeks of treatment, an additional 4-8 week course of NEXIUM may be considered. It is indicated to maintain symptom resolution and healing of erosive esophagitis. (Controlled studies do not extend beyond 6 months.) It is indicated for treatment of heartburn and other symptoms associated with GERD.
NEXIUM is approved for the short-term treatment (up to 8 weeks) of GERD in patients aged 12 to 17 years. The safety and effectiveness of NEXIUM for the treatment of symptomatic GERD in patients less than 12 years of ages and for other pediatric uses have not been established.
NEXIUM is als o approved for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (Greater Than or Equal To 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
Important Safety Information
NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.
The most frequently reported adverse events with NEXIUM include headache, diarrhea, and abdominal pain. In patients aged 12 to 17 years, the most frequently reported adverse events with NEXIUM include headache, diarrhea, abdominal pain, and nausea.
Symptomatic response to therapy does not preclude the presence of gastric malignancy.
Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated with long-term omeprazole, of which NEXIUM is an enantiomer.
As with all PPIs, patients treated comcomitantly with warfarin may need to be monitored for increases in INR and prothrombin time. Like other PPIs, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts, digoxin). Concomitant administration of esomeprazole may reduce the plasma levels of atazanavir.
Concomitant administration of esomeprazole may reduce the plasma of atazanavir.
NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information. For full Prescribing Information for NEXIUM please visit http://www.Nexium-us.com .
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 $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
In the United States, AstraZeneca is a $12.44 billion healthcare business with more than 12,000 employees. For nearly three decades, AstraZeneca has offered drug assistance programs side by side with its medicines, and over the past five years, has provided over $3 billion in savings to more than 1 million patients throughout the US and Puerto Rico. AstraZeneca has been named one of the "100 Best Companies for Working Mothers" by Working Mother magazine and is the only large pharmaceutical company named to FORTUNE magazine's 2007 list of "100 Best Companies to Work For." In 2006, for the fifth consecutive year, Science magazine named AstraZeneca a "Top Employer" on its ranking of the world's most respected biopharmaceutical employers.
For more information about AstraZeneca, please visit: http://www.astrazeneca.com
About Digestive Disease Week (DDW)
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, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 19-24, 2007, at the Washington Convention Center, Washington, DC. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit htt p://www.ddw.org .
CONTACT: Dana Settembrino, +1-302-885-6980, or Corey Smith,+1-302-885-0034, both of AstraZeneca
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