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Published on: October 12, 2017
Belgian data of ODYSSEY APPRISE: stringent LDL-c targets are in reach when using all available tools
Sébastien Verdickt1, Bart Van der Schueren1,2, Roman Vangoitsenhoven1,2
1Department of Diabetes and Endocrinology, University Hospitals of Leuven, Leuven, Belgium.
Insights
Alirocumab, a PCSK9 inhibitor, effectively lowers LDL-c in high-risk Belgian patients. This non-statin therapy is crucial for achieving lipid targets when statins alone are insufficient.
Area of Science:
- Cardiology
- Pharmacology
- Genetics
Background:
- Stringent lipid targets in ESC/EAS guidelines leave many patients above goal on statin monotherapy.
- This highlights the need for effective add-on lipid-lowering therapies.
- Alirocumab, a PCSK9 inhibitor, was evaluated in high cardiovascular risk patients.
Purpose of the Study:
- To analyze the characteristics, safety, and efficacy of alirocumab in the Belgian ODYSSEY APPRISE trial cohort.
- To evaluate the importance and necessity of add-on non-statin lipid-lowering therapy in clinical practice based on literature.
- To assess alirocumab's role in achieving guideline-directed lipid targets.
Main Methods:
- Prospective, single-arm, open-label, multicentric Phase 3b trial (ODYSSEY APPRISE).
- 68 Belgian patients enrolled, with 63 having heterozygous familial hypercholesterolaemia (HeFH).
- Evaluated LDL-c reduction and treatment-emergent adverse events (TEAEs) at 12 weeks.
Main Results:
- Mean baseline LDL-c was 188.7 mg/dL.
- A 59.9% mean LDL-c reduction was observed at 12 weeks in 65 evaluable patients.
- Overall TEAE incidence was 75.0%, with common events including back pain, nasopharyngitis, and injection site erythema.
Conclusions:
- Alirocumab demonstrated good tolerability, safety, and significant LDL-c reduction in the Belgian cohort within a real-world setting.
- Add-on non-statin therapy like alirocumab is essential for patients to reach their risk-based lipid targets.
- Clinical practice should increase initiation of alirocumab to improve lipid management.
Background:
As lipid targets became more stringent in the latest ESC/EAS guidelines, many patients on statin monotherapy are left above their risk-based target, increasing the need for lipid-lowering therapies. The results of the ODYSSEY APPRISE study were recently published by Gaudet et al In this trial, alirocumab (a PCSK9 inhibitor) was investigated in high cardiovascular risk patients in a real-life setting.
Objective:
We aim at analysing the characteristics, safety and efficacy of alirocumab in the Belgian population of the ODYSSEY APPRISE trial and, based on literature research, we aim to evaluate the importance and the need for the add-on, non-statin lipid-lowering therapy in clinical practice.
Methods And Results:
ODYSSEY APPRISE is a multicentric, prospective, single-arm, Phase 3b open-label trial. A total of 68 Belgian patients were enrolled, 63 patients had heterozygous familial hypercholesterolaemia (HeFH). Baseline mean LDL-c was 188.7 mg/dL (SD ± 51.8). At week 12, 65 patients had an evaluable efficacy end point with a mean LDL-c reduction of 59.9% from baseline. The overall incidence of treatment-emergent adverse events (TEAEs) was 75.0%. The most frequent TEAE was back pain (10.3%), nasopharyngitis (10.3%) and injection site erythema (8.8%). Based on the literature, a majority of patients do not reach their risk-based lipid target despite statin therapy alone.
Conclusion:
In a real-life setting, alirocumab is both well-tolerated, safe and very effective in reducing LDL-c in this Belgian cohort. In clinical practice, more patients should be initiated on the add-on, non-statin lipid-lowering therapy in order to reach their risk-based lipid target.
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