NEXIUM(R) Shown To Reduce Gastric Ulcers In At-Risk Patients Using Long-Term NSAIDs
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Pooled information from the double-blind, randomized, six-month
trials broadcast that to a great amount a minor amount patients
taking either NEXIUM 20 mg or NEXIUM 40 mg, in fixture to their
equal non-selective NSAID/COX-2-selective analysis, industry an
carbuncle at six months, report to those taking a placebo (5.2
percent and 4.6 percent, respectively, vs. 17 percent,
p0.001).(1) These divergence be see as precipitate as the
inspired month of prone and maintain through the be skilled
duration.(1) “Paradoxically, NSAID use wakeful be confirmed among
patients at glorious risk for gastric ulcers or other
complications associated beside these medications. Although
COX-2-selective drugs roughly rationale fewer gastric ulcers than
non- selective NSAIDs, these whereabouts aren’t categorically
eliminate, and the enduring side-effect rate non-living may be
high,” said James M. Scheiman, MD, Division of Gastroenterology,
Department of Internal Medicine, University of Michigan. “Data
from the two trials showed that NEXIUM be winning in reducing
abdomen ulcers in at-risk patients who necessitate seasoned NSAID
treatment.” In the first trial, known as Verification of
Esomeprazole for NSAID Ulcers and Symptoms (VENUS), a
significantly smaller percentage of patients taking NEXIUM 20 mg
or 40 mg developed a gastric or duodenal (occurring in the
commencement of the dumpy intestine) ulcer, compared to patients
subsequent to placebo (5.3 percent and 4.7 percent, respectively,
versus 20.4 percent, p0.001 and p0.0001).(1) In the second trial,
Prevention of Latent Ulceration Treatment Options (PLUTO), the
ulcer rates were 5.2 and 4.4 percent for patients on NEXIUM 20 mg
and 40 mg, respectively, versus 12.3 percent for those on placebo
(p0.018 and p0.007).(1) About the Trials The two study were
similar to, double-blind, randomized, placebo-controlled trials
involving a full of 844 (U.S.) and 585 (multinational) patients
who were at random elect in a 1:1:1 ratio to treatment with
either NEXIUM 20 mg, NEXIUM 40 mg or a placebo. Patients were
incessant NSAID user (i.e., acceptance all day non-selective
NSAID or COX-2 therapy for at smallest four weeks able to that
happening and throughout the duration of the six-month trial) at
risk of developing a gastric or duodenal ulcer as a end result of
older age (greater than or practically the same as to 60 years)
and/or a history of last gastric ulcers. At the time of the
study, patients were minus pay-out of ulcers and Helicobacter
pylori haze and showed no remnant of GI bleeding or perforation
inwardly the prior six months.
AstraZeneca R&D, Sweden, fund the study through a research
forfeit.
About NSAID-ulcer Risk Chronic NSAID use is a common cause of
gastric ulcers and have be associated with to the disappeared
effects inventory from heartburn to potentially life- hostile
stomach bleeding.(2) Of the greater than 14 million Americans who
use NSAIDs regularly to excess chronic pain,(3) up to 25% may be
false by NSAID-related ulcers.(4) Each year, in attendance are an
near 103,000 hospitalizations and 16,500 demise 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
indicate 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 passed for
treat repetitive, solid heartburn and other symptom associated
with acerbic reflux weakness, as powerfully as for the curing and
care of erosive esophagitis, a experience where stomach acid
begin to locate away away at the secret facing of the esophagus.
Most erosions treat in four to eight weeks.
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The supreme habitually report adverse events with NEXIUM include
headache, diarrhea and abdominal pain. For in profundity
prescribe data for NEXIUM, delight descend by About AstraZeneca
AstraZeneca (NYSE: AZN) is a requisite worldwide healthcare
ensemble occupied in the research, elevation, relationship, and
marketing of prescription pharmaceuticals and the appendage over
of healthcare services. It is one of the world’s chief
pharmaceutical company with healthcare sale of $23.95 billion and
leading lodge 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 troop. AstraZeneca is timetabled
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2 Scheiman JM and Fendrick AM. Practical approach to minimize
gastrointestinal and cardiovascular sanctuary concern 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: /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.
3. UKPDS Group. Intensive blood glucose control with
sulphonylureas or insulin compared with normal treatment and risk
of coplications in patients with type 2 diabetes. The Lancet.
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 robustness prudence 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- base guidelines for the prescription of nonsteroidal
anti-inflammatory drugs. Gastroenterology 2005;129:1171-1178.
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