Anna D. Garrett, PharmD, BCPS, CPP
Dr. Garrett is manager of the Health Education Center at Mission Hospitals in Asheville, North Carolina.
Study Offers New Direction for Antiplatelet Therapy after Stroke
The results of a recent study of anti-platelet
therapy for noncardioembolic
stroke suggest that clopidogrel is as
effective for secondary prevention as
aspirin combined with extended-release
dipyridamole (ERDP). The ProFESS trial is
the largest stroke trial ever performed,
with more than 20,000 patients enrolled
in 35 different countries. Investigators
compared clopidogrel with ERDP/aspirin
for secondary stroke prevention. No
differences were reported in recurrent
stroke rates between the 2 arms of the
study (9% over 2.5 years). Bleeding rates
were not significantly different.
The investigators concluded that
clopidogrel and aspirin/ERDP are similar
in efficacy and safety. As a result of this
trial, an increase in the use of singleagent
clopidogrel for secondary prevention
for ischemic stroke is likely.
AHRQ Publishes Guide to Prevention of Venous Thromboembolism
The Agency for Healthcare Research and
Quality (AHRQ) of the US Department
of Health and Human Services has
published a guide, Preventing Hospital-Acquired Venous Thromboembolism,
to help hospitals develop and sustain
strategies to reduce the incidence of
deep vein thrombosis and pulmonary
embolism in their surgical patients and
other patients.
The free, 50-page guide also includes
case studies, as well as examples of
chart audit and other forms. Printed
copies can be ordered by calling 800-358-9295, or sending an e-mail to .
DVT Awareness Month Is Coming up in March
March is Deep Vein Thrombosis (DVT) Awareness Month. This initiative was started 6
years ago after the death of David Bloom, a reporter, in Iraq. Mr. Bloom was embedded
with US forces and was traveling in a tank with military personnel. He died from
a pulmonary embolus (PE). His wife, Melanie, is an advocate for DVT awareness
and worked with the Coalition to Prevent DVT to have March recognized as DVT
Awareness Month.
According to the American Heart Association, up to 2 million Americans are
affected annually by DVT. Of those who develop PE, up to 200,000 will die each
year. More Americans die annually from DVT/PE than from breast cancer and AIDS
combined. According to a national survey sponsored by the American Public Health
Association, 74% of Americans have little or no awareness of DVT.
DVT Awareness Month is a perfect time to work with patients and other health
care providers to raise awareness of the dangers of DVT and PE. For more information,
visit www.preventdvt.org. The Web site offers a free risk assessment for the
public as well as press releases and other media resources for health care professionals.
Innohep Study Stopped Early Due to Increased Death Rate
The FDA is investigating information it
received about the clinical study Innohep
in Renal Insufficiency Study (IRIS),
which was stopped in February 2008
by the study's Data Safety Monitoring
Committee. Interim findings of the study
showed an increase in all-cause mortality
in patients who received Innohep
(tinzaparin). This multicenter European
study was designed to evaluate the
safety of Innohep, a low-molecular-weight
heparin, compared with unfractionated
heparin (UFH) in treating deep
vein thromboses (DVT) and/or pulmonary
emboli (PE) in patients older than
70 years of age who had impaired renal
function.
At the time the study was stopped,
350 patients had completed 90 days
follow-up. Of these, 23 of the 176 (13%)
patients in the Innohep-treated group
and 9 of the 174 (5%) patients in the
UFH-treated group had died. From the
information currently available to the
FDA, no clear pattern exists as to the
causes of death. The causes of death do
not appear to be dose-related. The currently
available data are not sufficient to
rule out the possibility of another DVT
or PE, or both, in patients who received
Innohep. Although preliminary data do
not appear to indicate a manufacturing
problem with Innohep or the UFH used
in the study, the FDA cannot rule out
this possibility until a thorough analysis
of the detailed manufacturing data is
completed.
Inside the Issue
