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most appropriate approach to reduc-
ing the risk of using dietary supple-
ment products containing ephedrine
alkaloids.
The National Advisory Council for
the National Center for
Complementary and Alternative
Medicine, part of the National
Institutes of Health (NIH), was sched-
uled to meet on March 17 to assess the
evidence on ephedra’s safety and effec-
tiveness in order to develop a research
agenda on ephedra. FDA will give that
committee an opportunity to com-
ment on the notice, should the com-
mittee find it appropriate to do so.
Health care practitioners are being
urged to submit written comments to
the FDA or report any known adverse
events related to ephedra use to
www.fda.gov/medwatch.
Sleeping PatternImportant in Reducing SIDS
Infants accustomed to sleeping on
their backs who are then placed to
sleep on their stomachs or sides are at
an increased risk for SIDS—greater
than the increased SIDS risk of infants
always placed on their stomachs or
sides, according to a newly released
study.
The study, conducted by Kaiser
Permanente in Northern and Southern
California and supported by the
National Institute of Child Health and
Human Development (NICHD) and
the National Institute on Deafness and
Other Communications Disorders,
appears in American Journal of
Epidemiology.
The study also shows that infants
sleeping on their sides are at an
increased risk of SIDS. The researchers
think that a large part of the risk may
be due to the instability of the side
sleeping position and the tendency for
infants sleeping in this position to turn
onto their stomachs.
The study, which was conducted in
11 counties in Northern and Southern
California, is the first to examine the
relationship between infant sleeping
position and SIDS in a racially diverse
U.S. population. The incidence of
SIDS has declined over 50 percent
since 1992, when the American
Academy of Pediatrics recommended
that infants be placed on their backs to
sleep. Before the current study, evi-
dence of the link between stomach
sleeping and SIDS risk was based
largely on overseas studies, where pop-
ulations and cultural practices are dif-
ferent from those in the U.S.
The researchers also collected infor-
mation about bedding materials, type
of mattress, room- or bed-sharing,
room temperature, exposure to passive
smoking and infant sickness. The
researchers found that infants last
placed on their sides for sleep were
twice more likely to die of SIDS than
infants last placed on their backs. In
addition, the risk of SIDS was signifi-
cantly increased if infants turned from
their sides to their stomachs during
sleep. While the reason isn’t clear, the
researchers think that the instability of
the side position makes it more likely
for babies who are placed to sleep in
this position to roll over onto their
stomachs.
A pattern also emerged when the
researchers looked specifically at the
position in which an infant was last
placed to sleep, compared to their
usual sleeping position. If an infant
who was usually placed to sleep in the
low-risk position—on the back—was
then placed to sleep in a high-risk
position (the stomach or side), his or
her SIDS risk was seven to eight times
greater than that of an infant who was
always placed to sleep on his or her
back. “The message here is ‘every night
and nap time count,’” said study co-
author Dr. Marian Willinger of
NICHD. “Parents and caregivers
should place their babies on their
backs every time they go to sleep.
Consistency is the key.”
One of the strengths of this study is
that the researchers interviewed a
racially—and culturally diverse group
of mothers—White, African American,
Hispanic, and Asian/Pacific Islander,
although the small sample size limited
the researchers’ ability to examine risk
within each racial group. This study
provides results from the first study of
infant sleeping position in relation to
SIDS risk to be collected entirely after
the NICHD’s “Back to Sleep” cam-
paign is launched to inform the public
about the importance of sleep position
in preventing SIDS.
Low-Dose WarfarinPrevents Clot Recurrence
Astudy of long-term, low-dose
warfarin to prevent the recur-
rence of the blood clotting disorders
deep vein thrombosis (DVT) and pul-
monary embolism (PE) resulted in
such a high degree of benefit to the
patients—without significant adverse
106 AWHONN Lifelines Volume 7 Issue 2
effects—that the National Heart,
Lung, and Blood Institute (NHLBI)
of the National Institutes of Health,
in Bethesda, MD, stopped the study
early.
The multicenter Prevention of
Recurrent Venous Thromboembolism
(PREVENT) trial found a 64 percent
reduction in episodes of DVT and pul-
monary embolism in study partici-
pants taking low-dose warfarin com-
pared to those taking a placebo.
Furthermore, there was no evidence of
significant risks such as major hemor-
rhage or other potential side effects of
warfarin, which is an anticoagulant—a
drug that prevents blood clotting.
At the time the study was terminat-
ed, patients had been followed for up
to about four years, with an average of
about two years. All study participants
had experienced a previous episode of
either DVT or PE placing them at
greater risk of a recurrence.
PREVENT is the first study to eval-
uate the use of low-dose warfarin for
the long-term prevention of venous
thromboembolism (VTE), a term that
includes both DVT and pulmonary
embolism. The study is published in
the April 10, 2003, issue of The New
England Journal of Medicine. Due to its
importance, the journal posted the
article online on February 24.
The trial, which began in 1998, was
scheduled to run until 2005. However,
at a regularly scheduled meeting of the
study’s independent Data and Safety
Monitoring Board (DSMB) held
December 4, 2002, the interim findings
were reviewed, and based on the
strong benefit of low-dose warfarin,
the DSMB recommended halting the
study. The recommendation was
approved by the NHLBI.
The current standard treatment for
DVT and pulmonary embolism not
associated with surgery or another
specific cause is 5 to 10 days of intra-
venous or subcutaneous heparin fol-
lowed by three to six months of full-
April | May 2003 AWHONN Lifelines 107
Levels of a type of adult stem
cell in the bloodstream may
indicate a person’s risk of develop-
ing cardiovascular disease, according
to a study supported by the NHLBI.
The study looked at the blood
level of endothelial progenitor cells,
which are made in the bone marrow
and may help the body repair dam-
age to blood vessels. Scientists from
NHLBI and Emory University
Hospital in Atlanta, GA, found that
cardiovascular disease risk was high-
er in persons with fewer endothelial
progenitor cells. The cells of those at
higher risk also aged faster than
those at lower risk, as determined by
the Framingham Heart Study risk
factor score, a standard measure-
ment of cardiovascular risk.
Additionally, the study found that
blood vessels were much less likely
to dilate and relax appropriately in
persons with low levels of the cells.
Results of the study, which
involved 45 healthy men aged 21
and older, some of whom had stan-
dard cardiovascular risk factors,
appeared in the February 13, 2003,
issue of The New England Journal of
Medicine.
Researchers wrote that they
believe that these endothelial pro-
genitor cells patch damaged sites in
blood vessel walls. When the cells
start to run out, cardiovascular dis-
ease worsens. “We don’t yet know
what causes their depletion but it
may be related to the fact that the
risk of cardiovascular disease
increases as people age. For instance,
the cells may be used up repairing
damage done by other risk factors
or those risk factors could directly
affect the survival of the endothelial
cells themselves.” They noted that
some day it may be possible to test a
person’s risk of cardiovascular dis-
ease by taking a blood sample and
measuring these cells. If the level is
too low, an injection of endothelial
cells might boost the body’s ability
to repair itself and prevent more
blood vessel damage.
NNeeww HHeeaarrtt DDiisseeaassee RRiisskk IInnddiiccaattoorr DDiissccoovveerreedd
dose warfarin. Therapy typically stops
after the initial treatment period
because long-term use of full-dose
warfarin is associated with a substan-
tial risk of major bleeding. After the
initial therapy is completed, recurrent
blood clots occur in 6 to 9 percent of
patients each year. The new data
demonstrate that these recurrent
blood clots can be avoided using an
inexpensive and safe therapy.
If DVT is not treated, it can lead to
pulmonary embolism in which the
clots detach and travel through the
bloodstream to the lungs, where they
may enter a pulmonary artery. Large
clots that completely block the pul-
monary artery can be fatal. Symptoms
of pulmonary embolism include sud-
den shortness of breath, sharp chest
pain, a cough with bloody sputum,
excessive sweating, rapid pulse and
lightheadedness. Acute DVT can also
lead to complications like chronic
venous insufficiency, which is charac-
terized by pooling of blood, chronic
leg swelling and increased pressure on
the skin.
There are a number of risk factors
for DVT and pulmonary embolism,
including long periods of inactivity,
which decrease blood flow. People who
are immobile after surgery or serious
injuries and travelers on long trips are
at increased risk of blood clots.
In addition, the hormone estrogen
found in birth control pills has been
shown to increase the risk of blood
clots. The results of the Women’s
Health Initiative study, reported last
July, found significant increases in
pulmonary embolism in healthy
women taking combined estrogen and
progestin.
Genes Linked to Severe Lupus
Agenetic “signature” may be the
key to understanding why some
Lupus sufferers have such severe
symptoms, say a team of scientists
supported by the National Institute of
Arthritis and Musculoskeletal and
Skin Diseases. This genetic “signature”
is present in some patients with sys-
temic lupus erythematosus (SLE) who
develop such life-threatening compli-
cations as blood disorders, central
nervous system damage and kidney
failure.
Using DNA microarrays—small sil-
icon chips that contain tiny amounts
of thousands of known genes—to
carry out a technique called gene
expression profiling, researchers ana-
lyzed thousands of genes in the
peripheral blood cells of 48 lupus
patients and 42 healthy controls.
Surprisingly, 14 of the thousands of
genes studied were linked to a subset
of SLE patients with severe disease. In
addition, 161 of the genes studied
showed different expression patterns
in SLE patients compared with healthy
controls.
The 14 genes, referred to collective-
ly as the IFN (interferon) expression
signature, are turned on by the activity
of interferon, a complex family of pro-
teins involved in the regulation of
immune responses. The data,
researchers say, provide strong support
for developing new therapies to block
IFN pathways in patients with severe
lupus, and the pattern of gene expres-
sion in blood cells may be useful in
identifying patients most likely to ben-
efit from these new therapies. Gene
expression profiling in blood cells may
also be useful in identifying disease
pathways in other autoimmune and
inflammatory disorders.
SLE, or lupus, is a chronic, inflam-
matory, autoimmune disease. Its
symptoms range from unexplained
fever, swollen joints and skin rashes to
severe organ damage of the kidneys,
lungs or central nervous system. Lupus
is difficult to diagnose because it’s dif-
ferent for every person who has it, and
it affects women nine times more
often than men.
MRI for Diagnosing Heart Attacks
Advanced magnetic resonance
imaging (MRI) technology can
detect heart attack in emergency room
patients with chest pain more accu-
rately and faster than traditional meth-
ods, according to a new study support-
ed by the NHLBI.
Published in the February 4 issue of
Circulation: Journal of the American
Heart Association, the findings suggest
108 AWHONN Lifelines Volume 7 Issue 2