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Cholesterol Drug Fails To Slow Progression Of Coronary Disease, Cleveland Clinic Study Reports
Cleveland Clinic researchers
today report that the drug torcetrapib, despite raising high density
lipoprotein cholesterol (HDL) or the "good" cholesterol by more than 60%,
did not slow the progression of plaque buildup in the coronary arteries as
measured using an ultrasound probe.
Steven Nissen, M.D., Chairman of Cardiovascular Medicine at Cleveland
Clinic and lead investigator of this clinical trial, will present the study
on Monday, March 26 at 8:30 a.m. at the American College of Cardiology's
(ACC) 56th Annual Scientific Session. Dr. Nissen is also President of the
ACC. The study will be simultaneously published in the New England Journal
of Medicine.
All development of this drug was terminated on Dec. 2, 2006 after the
safety board monitoring a separate large clinical outcomes trial reported
that torcetrapib increased the risk of death and other adverse
cardiovascular outcomes.
"We found that the torcetrabip/atorvastatin combination markedly
increased good cholesterol levels and lowered bad cholesterol in patients.
Unfortunately this drug also substantially raised blood pressure and failed
to slow the buildup of plaque," Dr. Nissen said. "It is yet to be
determined of this failure represents a problem unique to torcetrapib or
predicts a lack of efficacy for the entire class of similar drugs. These
findings further demonstrate the great difficulty in developing therapies
to disrupt the atherosclerotic disease process."
The development of drugs to raise HDL has been a key research priority
because, despite lowering LDL (low-density lipoprotein, or "bad")
cholesterol with statin drugs, many patients continue to experience heart
attacks, stroke or sudden cardiac death.
A total of 1,188 coronary artery disease patients were enrolled in the
"Investigation of Lipid Level management using coronary UltraSound To
assess Reduction of Atherosclerosis by CETP Inhibition and HDL Elevation"
(ILLUSTRATE) trial. All patients had a clinical indication for cardiac
catheterization, had a baseline intravascular ultrasound (IVUS) and
received 10-80 gm of atorvastatin adjusted during a two- to 10-week period
until LDL levels reached national guidelines.
Patients were then randomized to receive either 60 mg of torcetrapib or
a matching placebo for two years. At the end of the treatment period, a
second IVUS was performed, examining the same coronary arteries.
Researchers measured the change in plaque volume in the artery, comparing
the baseline to the follow-up ultrasound. They also measured patients'
blood cholesterol levels and biomarkers of inflammation at several points
during the trial.
Patients in the torcetrapib/atorvastatin group experienced a 61 percent
relative increase in HDL cholesterol levels and a 20 percent relative
decrease in LDL levels, as compared with patients in the atorvastatin-only
group. Despite those results, there was no statistical difference between
the two groups in plaque volume changes. Plaque volume increased by 0.19
percent in the atorvastatin-only patients and 0.12 percent in the
combination group, p = 0.72. Torectrapib was also associated with a
substantial increase in blood pressure, averaging 4.6 mm.
IVUS is a technique in which a tiny ultrasound probe is inserted into
the coronary arteries, providing a precise and reproducible method for
determining the change in plaque, or atheroma, burden during treatment.
Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit
multispecialty academic medical center that integrates clinical and
hospital care with research and education. Cleveland Clinic was founded in
1921 by four renowned physicians with a vision of providing outstanding
patient care based upon the principles of cooperation, compassion and
innovation. U.S. News & World Report consistently names Cleveland Clinic as
one of the nation's best hospitals in its annual "America's Best Hospitals"
survey. Approximately 1,800 full-time salaried physicians and researchers
at Cleveland Clinic and Cleveland Clinic Florida represent more than 100
medical specialties and subspecialties. In 2005, there were 2.9 million
outpatient visits to Cleveland Clinic. Patients came for treatment from
every state and from more than 80 countries. There were nearly 54,000
hospital admissions to Cleveland Clinic in 2005. Cleveland Clinic's Web
site address is http://www.clevelandclinic.org.
The American College of Cardiology (http://www.acc.org) represents the
majority of board certified cardiovascular physicians in the United States.
Its mission is to advocate for quality cardiovascular care through
education, research, promotion, development and application of standards
and guidelines- and to influence health care policy. ACC.07 and the ACC
inaugural i2 Summit, the first-ever meeting for interventional
cardiologists, will bring together more than 30,000 cardiologists and
cardiovascular specialists to share the newest discoveries in the treatment
and prevention, while helping the ACC achieve its mission to address and
improve issues in cardiovascular medicine.
Cleveland Clinic
http://www.clevelandclinic.org
Colesterol de droguri nu reuºeºte sã încetineascã progresia bolii coronariene, Cleveland Clinic de studiu rapoarte - Cholesterol Drug Fails To Slow Progression Of Coronary Disease, Cleveland Clinic Study Reports - articole medicale engleza - startsanatate