Phase 3
Completed N=615
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
Source: ClinicalTrials.gov NCT02715726 ↗Enrolled (actual)
615
Serious AEs
10.5%
Results posted
Sep 2019
Primary outcomePrimary: Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis — -20.3; -56.0 percent change — p=<0.0001
◆ Published Evidence
Established
49citations · ~8 / year
ODYSSEY EAST: Alirocumab efficacy and safety vs ezetimibe in high cardiovascular risk patients with hypercholesterolemia and on maximally tolerated statin in China, India, and Thailand.
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.
Linked Publications
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ODYSSEY EAST: Alirocumab efficacy and safety vs ezetimibe in high cardiovascular risk patients with hypercholesterolemia and on maximally tolerated statin in China, India, and Thailand.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis |
-20.3; -56.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis |
-21.3; -58.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: ITT Analysis |
-22.2; -57.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: On-Treatment Analysis |
-22.7; -58.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Analysis |
-16.2; -43.5 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 24: On-Treatment Analysis |
-17.4; -45.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24: ITT Analysis |
-19.4; -47.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis |
-20.4; -49.1 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24: ITT Analysis |
-13.8; -33.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Analysis |
-16.5; -43.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 12: ITT Analysis |
-20.7; -47.4 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol at Week 12: ITT Analysis |
-14.9; -34.2 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: ITT Analysis |
40.5; 85.1 | <0.0001 sig |
| SECONDARY Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: On-Treatment Analysis |
42.1; 87.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 24: ITT Analysis |
3.956; -30.317 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 24: ITT Analysis |
6.5; 8.3 | 0.2280 |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides (TG) at Week 24: ITT Analysis |
-14.409; -14.462 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24: ITT Analysis |
-0.2; 3.2 | — |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Analysis |
6.313; -30.064 | — |
| SECONDARY Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12: ITT Analysis |
6.1; 7.3 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 12: ITT Analysis |
-13.585; -9.965 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein A-1 at Week 12 : ITT Analysis |
1.1; 3.7 | — |
Eligibility Criteria
Inclusion criteria
Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at a stable dose for at least 4 weeks prior to the screening visit (Week -3).
Exclusion criteria
- Participants without established CHD or CHD risk equivalents.
- LDL-C 400 mg/dL (>4.52 mmol/L) at the screening period.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT02715726) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.