New Drug Can Dramatically Improve Cholesterol Levels
The researchers, from Boston's Brigham and Women's Hospital, have revealed that although some patients are unable to lower their bad cholesterol solely by use of statins, AMG 145 can effectively help.
The new, dose-ranging, double-blind trial was controlled by a placebo and conducted on 631 individuals ages 18 to 80 who reported a history of high cholesterol even while taking a single dose of statin, whether with ezetimibe, or without. The participants were randomly given 1 of 6 different AMG 145 dose regimens or a placebo of the same dose by means of an injection under the skin, either every 2 weeks or every 4 weeks for a 3 month period.
Those who were given AMG 145 every 2 weeks showed lower LDL cholesterol levels by 42 to 66% after 3 months, compared with the placebo group. The people who were given AMG 145 every 4 weeks saw a reduction of 42 to 50 % by the end of the 3 month period, compared with the placebo group.
Lead author of the study Robert Giugliano, MD, BWH Cardiovascular Division, Department of Medicine, and investigator for the Thrombolysis in Myocardial Infarction (TIMI) study, said, "The observed reductions in LDL cholesterol are extraordinary, especially when one considers that they are seen on top of statin therapy."
When given the highest dose possible every 2 weeks, 93.5% of participants were able to reach their cholesterol goals. There were also no serious side effects reported with the use of AMG 145 treatment.
The study's senior author Marc Sabatine, MD, chairman of the the TIMI Study Group, commented, "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."
AMG 145, a monoclonal antibody, binds to a protein that is involved in the eventual destruction of LDL cholesterol receptors. By inhibiting that protein, the drug prevents the destruction of the receptors, which in turn, results in more LDL cholesterol receptors on the surface of the liver. This helps clear the bloodstream of bad cholesterol.
The use of this new drug will help continue to improve the cholesterol levels of the population. Currently, adult levels are improving among U.S. adults.
Written by Christine Kearney