Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4

Summary

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

Timeline

Start

2016-02-27

Primary completion

2017-08-10

Completion

2018-05-26

Outcome

Met primary endpoint

registry analysis (superiority test); Ezetimibe vs Evolocumab; p <0.0001; LS Mean Treatment Difference -39.35 (95% CI -47.23 to -31.48) NCT02634580 ↗

registry analysis (superiority test); Ezetimibe vs Evolocumab; p < 0.0001; LS Mean Treatment Difference -40.14 (95% CI -48.68 to -31.60) NCT02634580 ↗

paper CONCLUSION: Evolocumab was superior to ezetimibe in reducing LDL-C during the 12-week double-blind period PMID 31748467 ↗

Publications

• Koba S, Inoue I, Cyrille M, Lu C, Inomata H, Shimauchi J, Kajinami K. Evolocumab vs. Ezetimibe in Statin-Intolerant Hyperlipidemic Japanese Patients: Phase 3 GAUSS-4 Trial. J Atheroscler Thromb. 2020 May 1;27(5):471-484. doi: 10.5551/jat.50963. Epub 2019 Nov 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evolocumab	Monoclonal antibody	140 mg	Subcutaneous
Subject	Evolocumab	Monoclonal antibody	420 mg	Subcutaneous
Comparator	Ezetimibe	Unknown	10 mg	Oral

Indications