Lipid-Lowering Efficiency and Safety of Alirocumab 300 mg Using a 2-mL Autoinjector Device in Real-World Practice:...

Area of Science:

• Cardiovascular Medicine
• Pharmacology
• Medical Devices

Background:

• Alirocumab is a monoclonal antibody targeting PCSK9 for LDL-C reduction in high-risk patients.
• A 2-mL prefilled autoinjector was developed for monthly 300-mg alirocumab administration.

Purpose of the Study:

• To assess the effectiveness of the 2-mL SYDNEY autoinjector for monthly 300 mg alirocumab administration.
• To evaluate patient satisfaction, adherence, and persistence with the device.
• To document the safety and tolerability of the alirocumab autoinjector system.

Main Methods:

• A non-interventional, open, prospective, multi-center cohort study in Germany (2021-2023).
• 146 patients with hypercholesterolemia and vascular disease were observed for 12 weeks.
• Patients were either PCSK9 inhibitor-naïve or pre-treated.

Main Results:

• Median LDL-C decrease of 59.5 mg/dL (52.0% relative decrease) in PCSK9 inhibitor-naïve patients at 12 weeks.
• Minimal change in LDL-C in pre-treated patients (1.6% relative increase).
• High patient satisfaction with device handling, safety, and effectiveness; 8.0% experienced adverse events.

Conclusions:

• Alirocumab 300 mg via the 2-mL SYDNEY autoinjector is safe and effective for LDL-C reduction in a real-world clinical setting.
• The monthly dosing regimen demonstrated excellent device acceptance and patient satisfaction.
• The system has the potential to improve patient adherence to lipid-lowering therapy.