AMG 134 success in GAUSS study in patients intolerant of statins

Amgen has announced positive results from the AMG 145 Phase II GAUSS study, in patients with high cholesterol who cannot tolerate statins. Reductions of up to 51 percent were observed in low density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, with AMG 145 and 63 percent with the combination of AMG 145 and ezetimibe, compared to 15 percent with ezetimibe alone. AMG 145 is an investigational fully human monoclonal antibody directed against PCSK9, a protein that reduces the liver's ability to remove LDL-C from the blood.

The study was published in Journal of the American Medical Association and simultaneously presented in an oral session at the American Heart Association Scientific Sessions 2012. see "Effect of a Monoclonal Antibody to PCSK9 on Low-Density Lipoprotein Cholesterol Levels in Statin-Intolerant Patients-The GAUSS Randomized Trial."-David Sullivan, MD Anders G. Olsson, MD, PhDRob Scott, MD Jae B. Kim, MD Allen Xue, PhD ,Val Gebski, MStat, Scott M. Wasserman, MD Evan A. Stein, MD, PhD- JAMA. 2012;():1-10. doi:10.1001/jama.2012.25790.