Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia

Summary

This study is being done to learn more about evolocumab in Chinese people with primary hypercholesterolemia or mixed dyslipidemia. This study will see if evolocumab will reduce low density lipoprotein cholesterol (LDL-C) in Chinese people who are also taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects.

Timeline

Start

2019-05-09

Primary completion

2020-04-24

Completion

2020-05-09

Outcome

Met primary endpoint

Stopped: “Prematurely Discontinued Amgen decision”

registry analysis (superiority test); Placebo Q2W vs Evolocumab 140 mg Q2W; p < 0.0001; Treatment difference -70.73 (95% CI -77.98 to -63.48) NCT03433755 ↗

registry analysis (superiority test); Placebo QM vs Evolocumab 420 mg QM; p < 0.0001; Treatment difference -69.74 (95% CI -76.51 to -62.97) NCT03433755 ↗

registry analysis (superiority test); Placebo Q2W vs Evolocumab 140 mg Q2W; p < 0.0001; Treatment difference -70.87 (95% CI -79.47 to -62.27) NCT03433755 ↗

registry analysis (superiority test); Placebo QM vs Evolocumab 420 mg QM; p < 0.0001; Treatment difference -65.81 (95% CI -73.97 to -57.66) NCT03433755 ↗

Publications

• Background Tan H, Li W, Huang Z, Han Y, Huang X, Li D, Xing X, Monsalvo ML, Wu Y, Mao J, Xin L, Chen J; HUA TUO study investigators. Efficacy and Safety of Evolocumab in Chinese Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia: 12-Week Primary Results of the HUA TUO Randomized Clinical Trial. Cardiol Ther. 2023 Jun;12(2):341-359. doi: 10.1007/s40119-023-00304-x. Epub 2023 Feb 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evolocumab	Monoclonal antibody	140 mg	Subcutaneous
Subject	Evolocumab	Monoclonal antibody	420 mg	Subcutaneous

Indications