Senior Citizens at
Risk of Heart Attack Gain New Hope from Powerful Anti-Cholesterol Drug
‘Anacetrapib has a
knock-your-socks-off effect on HDL and a jaw-dropping effect on LDL’ -
Dr. Christopher P. Cannon, senior investigator
Dr. Christopher P.
Cannon
Nov. 18, 2010 –
Exciting new hope for senior citizens at risk of a heart attack was
introduced yesterday. The experimental drug more than doubles the level
of good cholesterol and cuts the bad kind nearly in half, without the
blood pressure increase linked to another agent in its class, according
to late-breaking clinical trial results presented at the American Heart
Association’s Scientific Sessions 2010.
The 1,623
patients in a randomized, double-blind trial took either 100 milligrams
(mg) of the cholesterylester transfer protein (CETP) inhibitor
anacetrapib, or a placebo for 18 months at 153 centers in 20 countries.
The patients were already being treated with a statin and/or other
lipid-lowering medicine and had achieved their goal level of low-density
lipoprotein (LDL) cholesterol.
Large study in
New England Journal of Medicine says cardiac resynchronization
therapy can boost a fading heart beat - new hope for many senior
citizens - Nov. 14, 2010
Long delays between
developing heart attack symptoms and going to hospital are common -
learn about heart attack warnings below this news report. - Nov. 8, 2010
The study’s
primary endpoints were the percent change in LDL, known as the “bad”
cholesterol associated with the development of clogged arteries, and
safety as measured by a number of clinical and laboratory measures as
well as cardiovascular (CV) events.
Anacetrapib
reduced LDL by 40 percent — from 81 milligrams per deciliter (mg/dL) to
49 mg/dL. It also more than doubled the level of high-density
lipoprotein cholesterol (HDL) that helps clear lipids from the
bloodstream — from 40 mg/dL to 101 mg/dL — without raising blood
pressure.
Study
Highlights:
> An experimental cholesterol
drug significantly raises good cholesterol while reducing bad
cholesterol by almost half.
> The new drug did not appear
to have the blood pressure-raising effects of another agent in
the same class that was linked to increased deaths.
> If borne out by larger
studies, the research could provide a new class of
cholesterol-modifying drugs.
“Anacetrapib has
a knock-your-socks-off effect on HDL and a jaw-dropping effect on LDL,”
said Christopher P. Cannon, M.D., senior investigator of the TIMI Study
Group in the cardiovascular division of Brigham and Women’s Hospital in
Boston, Mass.
“These changes are striking because virtually all the
patients in the study were already taking cholesterol-lowering drugs and
achieved previously unattainable levels of good and bad cholesterol.”
The experimental
drug is one of a new class that blocks the ability of the CETP enzyme to
transfer cholesterol particles from the good HDL to the bad LDL.
Elevated LDL and
low levels of HDL are both risk factors for cardiovascular disease.
Statins reduce LDL and lessen cardiovascular risk. Despite statin
therapy, many patients still have a high risk of cardiovascular disease.
High natural
levels of HDL are associated with lower cardiovascular risk, which is
why researchers have been looking for ways to increase HDL levels, said
Cannon, an associate professor of medicine at Harvard Medical School.
“No treatments
raise HDL levels as substantially as seen here (more than doubling of
the levels),” said Cannon.
Patients in
DEFINE were 62.5 years old on average; 23 percent were women; 17 percent
were Asian, black or multiracial and 15 percent were Hispanic. The study
included interim safety analyses at six and 12 months, and researchers
found no change in blood pressure or electrolytes among participants.
Levels of
aldosterone, a hormone produced in the adrenal gland that affects kidney
function and blood pressure, didn’t change. The researchers also found
no increase in muscle problems or liver function abnormalities between
groups — a side effect occasionally associated with statins.
Although the
study was not designed or powered to assess the effects of anacetrapib
on cardiovascular events, fewer cardiovascular events occurred in the
anacetrapib group than in the statin-only group. The full efficacy and
safety of anacetrapib will be evaluated in a larger Phase III trial,
Cannon said.
“This agent
provides us a very strong add-on treatment to statins that dramatically
increases the good cholesterol and dramatically further decreases the
bad cholesterol,” he said. “If the cardiovascular effects are borne out
by future research, it would be a very promising approach to reducing
cardiovascular events in patients with or prone to atherosclerosis.”
The name of this
clinical trial is Determining the EFficacy and Tolerability of CETP
INhibition with AnacEtrapib (DEFINE).
Co-authors are
Sukrut Shah, R.Ph., Ph.D.; Hayes M. Dansky, M.D.; Michael Davidson,
M.D.; Eliot A. Brinton, M.D.; Antonio M. Gotto Jr., M.D., D.Phil.;
Michael Stepanavage, M.S.; Sherry Xueyu Liu, M.S.; Patrice Gibbons,
M.S.; Tanya B. Ashraf, B.A.; Jennifer Zafarino, M.S.; Yale Mitchel, M.D.
and Philip Barter, M.D., Ph.D. Author disclosures are on the abstract.
Merck Research
Laboratories, Rahway, N.J., funded the study.
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