Patients Unable
to Lower Bad Cholesterol with Statins
Find Success with New Drug
AMG 145 reduced LDL
cholesterol by 66% in
only 12 weeks
Nov. 6, 2012 -
People taking statin drugs to lower "bad
cholesterol" levels sometimes are
unsuccessful due to their body's
inability to tolerate or sufficiently
respond to the medicine. Researchers
announced today, however, that with the
addition of a new drug - AMG 145 - they
were able to help these patients reduce
the LDL cholesterol by 66 percent in
only 12 weeks.
In a double-blind,
dose-ranging, placebo-controlled study,
631 patients ages 18 to 80 years old
with high cholesterol on a stable statin
dose (with or without ezetimibe) were
randomized to receive one of six
different AMG 145 dose regimens or
matching placebo. The treatments were
given subcutaneously (an injection under
the skin) every two or every four weeks
for a total of twelve weeks.
In participants who
received AMG 145 every two weeks, the
drug reduced LDL cholesterol in a
dose-dependent manner by 42 to 66
percent at the end of twelve weeks
compared to placebo.
For those taking
AMG 145 every four weeks, the drug
reduced LDL cholesterol in a
dose-dependent manner by 42 to 50
percent at the end of twelve weeks
compared to placebo. Moreover, just one
week after a dose, researchers saw LDL
cholesterol reduced by up to 85 percent.
The highest dose
given every two weeks also allowed 93.5
percent of patients to achieve the most
stringent cholesterol-lowering goals.
Furthermore, the researchers noted that
there were no serious adverse events
that occurred with AMG 145 treatment.
"These data are
very exciting and may offer a new
paradigm for LDL cholesterol reduction.
The next step will be a large-scale,
long-term cardiovascular outcomes
trial," said Marc Sabatine, MD, chairman
of the TIMI Study Group, and senior
study author.
AMG 145 is a
monoclonal antibody. It binds to a
protein that normally shepherds LDL
cholesterol receptors for destruction.
By blocking that protein, AMG 145
protects the receptors from being
destroyed, thereby increasing the number
of LDL cholesterol receptors on the
surface of the liver that help remove
bad cholesterol from the bloodstream.
This research was
supported by Amgen, Inc., who
participated in the study design and
data collection. Data analyses were
performed and interpreted independently
by the TIMI Study Group, Brigham and
Women's Hospital.
> Medical
Malpractice,
> Nursing Home Abuse,
> Personal Injury
Our Experienced Lawyers Can Help
"We win because we care, we prepare
and we have no fear," Beth Janicek, board certified personal
injury attorney
Nov. 6, 2012 -
People taking statin drugs to lower "bad
cholesterol" levels sometimes are
unsuccessful due to their body's
inability to tolerate or sufficiently
respond to the medicine. Researchers
announced today, however, that with the
addition of a new drug - AMG 145 - they
were able to help these patients reduce
the LDL cholesterol by 66 percent in
only 12 weeks. 
"We win because we care, we prepare
and we have no fear," Beth Janicek, board certified personal
injury attorney