Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
Summary
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison to ezetimibe 10 mg daily after 24 weeks of treatment in Asia in participants with hypercholesterolemia at high cardiovascular (CV) risk. Secondary Objectives: * To evaluate the effect of alirocumab 75 mg in comparison with ezetimibe 10 mg on LDL-C after 12 weeks of treatment. * To evaluate the effect of alirocumab on other lipid parameters: e.g., apolipoprotein B (Apo B), non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein a (Lp\[a\]), HDL-C, triglycerides (TG), apolipoprotein A-1 (Apo A-1). * To evaluate the safety and tolerability of alirocumab. * To evaluate the development of anti-alirocumab antibodies. * To evaluate the pharmacokinetics (PK) of alirocumab.
Timeline
- Start
- 2016-07-27
- Primary completion
- 2018-08-06
- Completion
- 2018-08-06
Outcome
Met primary endpoint
registry analysis (superiority test); Ezetimibe 10 mg vs Alirocumab 75 mg Q2W/up to 150 mg Q2W; p <0.0001; LS mean difference -35.6 (95% CI -40.6 to -30.7) NCT02715726 ↗
paper LDL-C levels were reduced from baseline to week 24 by 56.0% and 20.3% in the alirocumab and ezetimibe groups, respectively (P < .0001 vs ezetimibe). PMID 31882376 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alirocumab | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Alirocumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Ezetimibe | Unknown | 10 mg | Oral |
| Background | Atorvastatin | Small molecule | — | Oral |
| Background | Rosuvastatin | Small molecule | — | Oral |
| Background | Simvastatin | Small molecule | — | Oral |