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 conference.
"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 specific mutations.
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 risk.
Because the second study was presented at a medical meeting, its conclusions should be viewed as preliminary until published in a peer-reviewed journal.
More information
For more about cholesterol, visit the U.S. National Library of Medicine.
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