November 7, 2012
LDL Cholesterol Lowered With Help Of New Drug Combined With Statins
April Flowers for redOrbit.com - Your Universe Online
Statins are the first line of defense for many people with high cholesterol. For some patients, however, statins do not reduce their low-density lipoprotein cholesterol (LDL) levels. LDL is considered the "bad cholesterol." Some patients' bodies are unable to tolerate statins, or they simply do not respond sufficiently to the medication.
631 patients aged 18 to 80 years old with high cholesterol on a stable statin dose (with or without ezetimibe) participated in a double-blind, dose-ranging, placebo-controlled study. They were randomized to receive one of six different AMG 145 dose regimens or matching placebo. The treatments were given subcutaneously every two or every four weeks for a total of twelve weeks.
For subjects on the two-week regimen, AMG 145 reduced LDL cholesterol in a dose-dependent manner by 42 to 66 percent at the end of twelve weeks compared to the placebo.
Participants on the four-week regimen saw a reduction of LDL cholesterol in a dose-dependent manner by 42 to 50 percent. Even more surprising, just one week after a dose, researchers saw an 85 percent reduction of LDL cholesterol.
"The observed reductions in LDL cholesterol are extraordinary, especially when one considers that they are seen on top of statin therapy," said Robert Giugliano, MD, BWH Cardiovascular Division, Department of Medicine, investigator for the Thrombolysis in Myocardial Infarction (TIMI) Study Group.
According to the study, 93.5 percent of patients achieved the most stringent cholesterol-lowering goals at the highest dose given every two weeks with no serious adverse side effects noticed.
"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.
AMG 145 is a monoclonal antibody that binds to a protein. This protein normally shepherds LDL cholesterol receptors for destruction, and by blocking that protein AMG 145 protects the receptors. This increases the number of LDL cholesterol receptors on the surface of the liver, helping to remove bad cholesterol from the bloodstream.