- NEXIUM(R) (esomeprazole magnesium) Proven Effective at Standard Doses
Regardless of Body Mass Index -
PHILADELPHIA, Oct. 16 /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 American College 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.
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 $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 American College 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
American College 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
American College 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.
SOURCE AstraZeneca
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Related links:
http://www.astrazeneca.com
http://www.nexium-us.com
http://www.prnewswire.com/comp/985887.html/
CONTACT:
Blair Hains, +1-302-885-1813, or Corey
Windett, +1-302-885-0034 both of AstraZeneca
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