Belgian data of ODYSSEY APPRISE: stringent LDL-c targets are in reach when using all available tools

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.