Studies Show Body Mass Index Has No Effect on Resolution and Healing of GERD Symptoms- NEXIUM(R) (esomeprazole magnesium) Proven Effective at Standard Doses Regardless of Body Mass Index -
PHILADELPHIA, October 16, 2007 /PRNewswire-FirstCall/ -- The link between gastroesophageal reflux disease (GERD) and obesity has long been established, but healthcare professionals have had little guidance as to whether obese patients with GERD should be treated differently than normal-weight patients with GERD. Two studies about obesity and its relationship to GERD were presented at the of Gastroenterology (ACG) Annual Scientific Meeting this week. One study, which evaluated symptom resolution in patients with non-erosive reflux disease, a type of GERD, received a 2007 ACG Presidential Poster Award. The other study examined GERD patients with erosive esophagitis, a condition in which stomach acid wears away, or erodes, the inner lining of the esophagus over time. Results of both studies showed despite whether a patient with GERD is considered obese or not, treatment should remain the same.(1)(2)
Body Mass Index (BMI) measures body fat by comparing a person's height to weight. A person with a BMI greater than 30 kg/m(2) is considered obese.(3) GERD is characterized by frequent, persistent heartburn (a burning feeling, rising from the stomach or lower part of the chest towards the neck) two or more days a week. It occurs when the valve between the esophagus and stomach does not close properly, allowing acid to leak back into the esophagus. When a person is overweight or obese, pressure inside the abdomen may increase causing this valve to relax, often leading to acid reflux.(3) In fact, studies have shown that people with a BMI greater than 30 kg/m(2) -- the cutoff for obesity -- face double the risk of developing GERD.(3)
"With obesity on the rise and more patients at risk for GERD than ever before, it's especially important that we understand how to treat overweight patients with GERD," said Prateek Sharma, MD, FACG, University of Kansas School of Medicine, an author for both analyses. "These analyses show that obese patients with GERD can probably follow the same treatment protocol as patients with GERD who are not overweight, with the same anticipated outcomes."
In the first study, data from two randomized, double-blind trials comparing NEXIUM(R) (esomeprazole magnesium) 20 mg or 40 mg once daily with placebo were pooled and analyzed. A total of 704 patients with non-erosive reflux disease -- meaning they had frequent heartburn but no evidence of erosion in the esophagus -- were included. The analysis showed that BMI had no significant effect on resolution of heartburn (P=0.9853) in patients treated with NEXIUM.(1)
The second study looked at a total of 11,027 GERD patients with erosive esophagitis, a condition in which stomach acid wears away, or erodes, the inner lining of the esophagus over time. About one in three people with frequent, persistent heartburn also have erosive esophagitis. Researchers analyzed five randomized, double-blind multicenter clinical studies that compared NEXIUM 40 mg once daily with omeprazole 20 mg once daily or lansoprazole 30 mg once daily. The analysis found that BMI had no significant effect on healing of erosions (P=0.2286) in patients treated with PPIs.(2)
"PPIs are the mainstay of therapy for patients with erosive and non-erosive GERD. These analyses tell us that the dosage of NEXIUM, one of the most well-studied PPIs, remains equally as effective regardless of a patient's weight, and does not need to be adjusted based on a patient's BMI-an ideal quality for any medication," said Debra Silberg MD, PhD, Senior Director Clinical Research at AstraZeneca and an author on both of the studies.
Dr. Silberg added that while these studies confirm that PPIs are effective therapies for GERD patients who are overweight or obese, losing weight through a healthy diet and regular exercise may also help alleviate symptoms.
The two studies presented at the meeting include:
Effect of Obesity on Symptom Resolution in Patients with Gastroesophageal Reflux Disease (GERD)
2007 ACG Presidential Poster Award Recipient Poster Presentation, Sunday, October 14, 2007 Exhibit Hall B, Pennsylvania Convention Center: Poster #30
Is Obesity the Cause of Reduced Healing Rates in Advanced Grades of Erosive Esophagitis?
Poster Presentation, Monday, October 15, 2007 Exhibit Hall B, Pennsylvania Convention Center: Poster #594
About NEXIUM(R) (esomeprazole magnesium)
NEXIUM, launched in the U.S. in 2001, 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 to 8 weeks of treatment, an additional 4 to 8 week course of NEXIUM may be considered. NEXIUM is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Common side effects with NEXIUM include headache, diarrhea, and abdominal pain. Symptom relief does not rule out other serious stomach conditions.
AstraZeneca is committed to helping people get the medicines they need. In 2006, 97,614 NEXIUM patients were provided patient assistance through AstraZeneca programs, which equates to patient savings of $105M.
Nationwide, the majority of people with prescription coverage can get NEXIUM for less than a dollar a day, based on the national average co-pay.(6) Individual costs may vary.
For more information about 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 the ACG
Founded in 1932, the of Gastroenterology (ACG) is an organization with an international membership of more than 9,000 individuals from 80 countries. The College is committed to serving the clinically oriented digestive disease specialist through its emphasis on scholarly practice, teaching and research. The mission of the College is to serve the evolving needs of physicians in the delivery of high quality, scientifically sound, humanistic, ethical, and cost-effective health care to gastroenterology patients.
(1) Sharma P, Vakil N, Monyak J, Silberg, D: Effect of Obesity Resolution in Patients with Gastroesophageal Reflux Disease (GERD). The of Gastroenterology Annual Scientific Meeting poster. Supported by AstraZeneca, LP, Wilmington, DE, USA.
(2) Vakil N, Sharma P, Monyak J, Silberg, D: Is Obesity the Cause of Reduced Healing Rates in Advanced Grades of Erosive Esophagitis (EE)? The of Gastroenterology Annual Scientific Meeting poster. Supported by AstraZeneca, LP, Wilmington, DE, USA.
(3) Hampel H, Abraham NS, and El-Serag HB. Meta-analysis: obesity and the risk for gastroesophageal reflux disease and its complications. Ann Intern Med. 2005;143(3):199-211.
(6) Source: Wolters Kluwer Health Source(R), Dynamic Claims Analyzer January through August 2007. Based on average monthly co-pay amount for commercial and Medicare Part D programs. Survey included 4100 plans; 63% of claims had a co-pay of $29 or less. Does not include other types of out-of-pocket costs. DA-NEX-99: Wolters Kluwer Health Source(R) Dynamic Claims TM, January through August 2007.
CONTACT: Blair Hains, +1-302-885-1813, or Corey Windett, +1-302-885-0034both of AstraZeneca
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Posted: October 2007