New Injection Might Lower Tough-to-Treat
MONDAY, March 26 (HealthDay News) -- Researchers report that
injections of a novel "monoclonal antibody" lowered LDL cholesterol
levels in patients with high cholesterol by as much as 72
This new treatment could help lower levels of "bad" cholesterol
for the one in five people who don't respond to the commonly
prescribed cholesterol-lowering drugs known as statins. It may also
be helpful in patients who can't get their cholesterol low enough
with statins alone, the researchers added.
"If this pans out, it will be a whole new approach to lowering cholesterol," James McKenney, chief executive officer of National Clinical Research Inc., said during a Monday press briefing at the American College of Cardiology annual meeting in Chicago, where the research was to be presented. A report on the findings was published simultaneously in the Journal of the American College of Cardiology.
The experimental compound appeared to lower LDL cholesterol by
making it easier for the liver to remove LDL cholesterol from the
bloodstream, McKenney said. Monoclonal antibodies are antibodies
cloned from a single cell, which are all identical because they are
cloned, the researchers explained.
The study was funded by the drug's manufacturers: Sanofi U.S.
and Regeneron Pharmaceuticals. The research company that McKenney
works for has also received funding from both drug makers.
For this phase 2 study, McKenney's team randomly assigned 183
patients with high cholesterol who had been treated with Lipitor
(atorvastatin) for more than six weeks, to one of six groups.
Three groups were given injections of the new drug in high,
medium or low doses every two weeks. Two other groups were given
very high doses of the drug every four weeks. The sixth group
received a placebo.
After 12 weeks, the researchers found those who received the low
dose of the monoclonal antibody saw their LDL levels drop by 40
percent. For those given the medium dose, LDL levels decreased 64
percent while those given the high dose saw their cholesterol
levels drop by 72 percent.
For those in the two groups taking very high doses every four
weeks, the drops in LDL cholesterol were 43 percent and 48 percent,
the researchers said.
McKenney noted there is a long way to go and much more research
is needed before this drug is ready for public use. Since it would
need to be taken regularly, he see it as akin to insulin where the
patient can inject the drug in measured doses.
In terms of cost, it's far too early to say what a patient would
have to spend for this therapy, the researchers said.
Longer trials are planned. The study authors said they feel
confident that the drug is safe and effective, but they need to
confirm the results over the long-term.
Dr. Gregg Fonarow, director of the Ahmanson UCLA Cardiomyopathy
Center and co-director of the UCLA Preventative Cardiology Program,
said that "statin therapy has been remarkably effective in reducing
fatal and nonfatal cardiovascular events."
Yet, many patients cannot achieve optimal reduction in LDL
cholesterol levels with statins and some patients do not tolerate
statins well, he noted.
"This novel, new therapy is exceptionally promising," Fonarow said. "Achieving LDL cholesterol reductions of up to 72 percent on top of statin therapy is very impressive."
"If further studies demonstrate the long-term safety, efficacy and effectiveness of this therapy, this will represent a tremendous advance in preventing and treating cardiovascular disease, which has remained the leading cause of premature death and disability in men and women," Fonarow added.
Results of another study also due to be presented Monday suggest
that starting statin therapy early in life might significantly
reduce the risk for heart disease.
Rather than actually treating patients with statins, the
researchers used a type of study that looks at changes in DNA that,
in this case, were linked to lower levels of cholesterol.
Since one has these mutations at birth, it's like being blessed
with naturally low cholesterol. These mutations stand in for statin
therapy, lead researcher Dr. Brian Ference, director of the
cardiovascular genomic research center at Wayne State University
School of Medicine in Indiana, said during Monday's press
"This research is a way of finding out the effects of lowering cholesterol early without having a lengthy clinical trial," Ference said.
The researchers looked at genes from participants of several
studies, one including more than 350,000 patients, and found nine
For each single measure of reduced lifetime exposure to LDL
cholesterol associated with having the mutations, the researchers
found a 50 percent to 60 percent reduction in heart disease
Because the second study was presented at a medical meeting, its
conclusions should be viewed as preliminary until published in a
For more about cholesterol, visit the
U.S. National Library of Medicine.
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