Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects

Phase 2 Completed 160 enrolled Amgen

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

Timeline

Start: 2011-07-28
Primary completion: 2012-05-08
Completion: 2012-05-08

Outcome

Met primary endpoint

registry Ezetimibe vs Evolocumab 420 mg; p <0.001; LS Mean Treatment Difference -35.94 (95% CI -44.08 to -27.80); ANCOVA; NCT01375764 ↗

registry Ezetimibe vs Evolocumab + Ezetimibe; p <0.001; LS Mean Treatment Difference -47.29 (95% CI -53.73 to -40.84); ANCOVA; NCT01375764 ↗

Publications

Background Sullivan D, Olsson AG, Scott R, Kim JB, Xue A, Gebski V, Wasserman SM, Stein EA. Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial. JAMA. 2012 Dec 19;308(23):2497-506. doi: 10.1001/jama.2012.25790.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evolocumab	Monoclonal antibody	280 mg	Subcutaneous
Subject	Evolocumab	Monoclonal antibody	350 mg	Subcutaneous
Subject	Evolocumab	Monoclonal antibody	420 mg	Subcutaneous
Subject	Ezetimibe	Unknown	10 mg	Oral