Desai, N. R., Giugliano, R. P., Zhou, J., Kohli, P., Somaratne, R., Hoffman, E., Liu, T., Scott, R., Wasserman, S. M., Sabatine, M. S. AMG 145, A Monoclonal Antibody Against PCSK9, Facilitates Achievement of NCEP-ATP III LDL-C Goals Among High Risk Patients: An Analysis From the LAPLACE-TIMI 57 Trial J Am Coll Cardiol. 2013;NA(NA):NA.

OBJECTIVE: To define the ability of AMG 145, a monoclonal antibody directed against PCSK9, to enable subjects at high risk for major adverse cardiovascular events to achieve NCEP-ATP III LDL-C and other lipid parameter goals.

BACKGROUND: Many patients at high risk for adverse CV events are unable to achieve NCEP-ATP III LDL-C goal of <70mg/dL, even with high potency statin therapy.

METHODS: In 282 subjects from the LAPLACE-TIMI 57 trial at high risk by NCEP-ATP III, we compared across treatment arms the proportion of subjects achieving NCEP-ATP III recommended LDL-C <70 mg/dL. Other outcomes included the triple goal of LDL-C <70 mg/dL, non-HDL-C <100 mg/dL, and ApoB <80 mg/dL.

RESULTS: Each dose of AMG 145 significantly increased the proportion of the patients achieving an LDL-C of <70 mg/dL, with ≥90% of subjects in both the top doses every 2 weeks and every 4 weeks attaining this lipid target over the dosing interval, with similar success rates for the triple lipid goal.

CONCLUSION: PCSK9 inhibition with AMG 145 enables high risk patients to achieve established lipid goals. If this therapy demonstrates efficacy for reducing CV events with a favorable safety profile in ongoing phase 3 trials, we believe it will have major public health implications.