понедельник, 30 мая 2011 г.

NEXIUM(R) Shown To Reduce Gastric Ulcers In At-Risk Patients Using Long-Term NSAIDs

Results from two
clinical trials, to be published in the April 2006 edition of the American
Journal of Gastroenterology, indicate that NEXIUM(R) (esomeprazole magnesium)
can reduce the incidence of gastric (stomach) ulcers in patients at risk of
developing gastric ulcers and who regularly take either non-selective
nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2-selective NSAIDs.(1)
NSAIDs are a class of pain relief medications that include traditional,
non-selective drugs, such as ibuprofen, naproxen and aspirin, and newer COX-2-
selective agents. Non-selective NSAIDs are known for increasing the risk of
gastric ulcers, particularly among older patients who take them regularly or
who have a history of gastric ulcers.


Pooled data from the double-blind, randomized, six-month trials showed
that significantly fewer patients taking either NEXIUM 20 mg or NEXIUM 40 mg,
in addition to their regular non-selective NSAID/COX-2-selective therapy,
developed an ulcer at six months, compared to those taking a placebo (5.2
percent and 4.6 percent, respectively, vs. 17 percent, p







AstraZeneca R&D, Sweden, funded the study through a research grant.


About NSAID-ulcer Risk


Chronic NSAID use is a common cause of gastric ulcers and has been
associated with side effects ranging from indigestion to potentially life-
threatening stomach bleeding.(2) Of the more than 14 million Americans who
use NSAIDs regularly to treat chronic pain,(3) up to 25% may be affected by
NSAID-related ulcers.(4) Each year, there are an estimated 103,000
hospitalizations and 16,500 deaths in the United States attributed to
complications from NSAID-associated gastric ulcers.(5) Among the elderly,
NSAID use accounts for nearly one third of gastric-ulcer-related
hospitalizations,(6) with an associated four-fold increased risk of death.(7)


About NEXIUM(R) (esomeprazole magnesium) Delayed-release Capsules


NEXIUM is indicated for reducing the risk of gastric ulcers developing
among at-risk patients on continuous NSAID therapy. Patients are considered
to be at risk if they are age 60 plus or if they have a history of previous
gastric ulcer. NEXIUM also is approved for treating frequent, persistent
heartburn and other symptoms associated with acid reflux disease, as well as
for the healing and maintenance of erosive esophagitis, a condition in which
stomach acid begins to wear away the inner lining of the esophagus. 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.
The most frequently reported adverse events with NEXIUM include headache,
diarrhea and abdominal pain. For full prescribing information for NEXIUM,
please visit nexium-us.


About AstraZeneca


AstraZeneca (NYSE: AZN) 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:
astrazeneca-us.


This press release contains forward-looking statements with respect to
AstraZeneca's business. By their nature, forward-looking statements and
forecasts involve risks and uncertainties because they relate to events and
depend on circumstances that will occur in the future. There are a number of
factors that could cause actual results and developments to differ materially.
For a discussion of those risks and uncertainties, please see the company's
Annual Report/Form 20-F for 2005.


References


1 Scheiman JM, et al. (2006) Prevention of Ulcers by Esomeprazole in At-
Risk Patients Using Non-Selective NSAIDs and COX-2 Inhibitors. Am J
Gastroenterology 0 (0), -.doi: 10.1111/j.1572-0241.2006.00499.x.


2 Scheiman JM and Fendrick AM. Practical approaches to minimizing
gastrointestinal and cardiovascular safety concerns with COX-2 inhibitors
and NSAIDs. Arthritis Research & Therapy 2005, 7(Suppl 4):S23-S29.


3 The Dangers of Aspirin and NSAIDs. American College of
Gastroenterology. Available at:

acg.gi/patients/women/asprin.asp.


4 Blower AL. Scand J Rheumatol 1996;25(suppl 105):13-26.

Singh G. Am J Med 1998;105:31S-38S.


5 Wolfe M, Lichtenstein R, Singh G. Gastrointestinal toxicity of
nonsteroidal anti-inflammatory drugs. N Engl J Med 1999;340:1888-1899.


6 Griffin MR et al. Nonsteroidal anti-inflammatory drug use and
increased risk for peptic ulcer disease in elderly persons. Ann Intern
Med 1991;114:257-263.


Griffin MR et al. Nonsteroidal anti-inflammatory drug use and death
from peptic ulcer disease in elderly persons. Ann Intern Med
1988;109:359-363.


Laine L et al. Gastrointestinal health care resource utilization with
chronic use of COX-2-specific inhibitors versus traditional NSAIDs.
Gastroenterology 2003;125:389-395.


(All citations above from Abraham NS et al. National adherence to
evidence-based guidelines for the prescription of nonsteroidal anti-
inflammatory drugs. Gastroenterology 2005;129:1171-1178.)


7 Griffin MR et al. Nonsteroidal anti-inflammatory drug use and death
from peptic ulcer disease in elderly persons. Ann Intern Med
1988;109:359-363. From Abraham NS et al. National adherence to evidence-
based guidelines for the prescription of nonsteroidal anti-inflammatory
drugs. Gastroenterology 2005;129:1171-1178.


AstraZeneca

astrazeneca-us

nexium-us


View drug information on Nexium.

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