(RxWiki News) For patients with stubborn cholesterol that is not easily lowered with statins or traditional care, an experimental injection of antibodies may do the trick. It has been found to offer a substantial cholesterol improvement.
Injection of the monoclonal antibody lowered bad LDL cholesterol between 40 percent and 72 percent in a randomized multi-center trial.
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James McKenney, chief executive officer of National Clinical Research, and the study's lead investigator, said it's been known for three decades that lowering LDL cholesterol with statins reduces the risk of heart disease. But, he noted that in some cases even the best statins are unsuccessful at lowering cholesterol to an acceptable level.
During the phase II anti-PCSK9 antibody trial, researchers enrolled 183 patients who had LDL cholesterol readings over 100 mg/dL. All of the participants had previously been treated with atorvastatin (Lipitor) for six weeks, receiving 10, 20 or 40 milligrams.
Patients were divided into six groups, including a placebo group, and three groups who received subcutaneous injections of the monoclonal antibody SAR236553/REGN727 every two weeks at doses of either 50, 100, or 150 milligrams, while the final two groups received injections of SAR236553/REGN727 at 200 or 300 milligrams every four weeks, alternating with placebo shots at two weeks. Participants were followed for 12 weeks.
Researchers had recently discovered that taking statins stimulates the production of PCSK9, an enzyme that destroys LDL receptors. In the present study, the monoclonal antibody binds to the PCSK9 enzyme and blocks its action. This way, the LDL receptors are not degraded, and more receptors are able to bring LDL cholesterol out of the blood and into the liver where it is safely stored, instead of circulating in the blood.
The cholesterol lowering benefit was found significant for all patients who received the injections. Patients that received 50, 100 or 150 milligram injections of the antibody saw circulating LDL cholesterol reductions of 40 percent, 64 percent and 72 percent, respectively. The groups that received 200 or 300 milligram injections experienced reductions of 43 percent and 48 percent. A 5 percent reduction in cholesterol was reported among the placebo group. One adverse reaction also was reported.
"Our LDL cholesterol treatment goals were less than 100 or 70 mg/dL. All of the participants receiving one of our doses met those goals," McKenney said. "Statins are good medicines and getting a 70 percent reduction on top of them is remarkable."
This study was funded by Sanofi US and Regeneron Pharmaceuticals. McKenney also is employed by a research company that has received research funding from Regeneron and Sanofi.
The research was presented Monday at the American College of Cardiology's annual scientific sessions, and simultaneously published in the Journal of the American College of Cardiology.