Lipid-lowering efficacy and safety of alirocumab in a real-life setting in France: Insights from the ODYSSEY APPRISE study - 05/02/23
Highlights |
• | Ancillary analysis of French patients enrolled in ODYSSEY APPRISE. |
• | Trial conducted to determine lipid-lowering efficacy and safety of alirocumab. |
• | Real-life setting: patients at high cardiovascular risk with hypercholesterolaemia. |
• | Statins and ezetimibe are the first and second-line therapies. |
• | These therapies are used even less in France than in other countries. |
• | Alirocumab was well tolerated, safe and highly effective at reducing LDL-C. |
• | This supports PCSK9 use to manage hypercholesterolaemia in high-risk CV patients. |
Abstract |
Background |
Recently, a multicentre, prospective, single-arm, phase 3b, open-label trial was conducted to determine the safety and efficacy of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, in a real-life setting. This study enrolled patients at high cardiovascular risk, with heterozygous familial hypercholesterolaemia (HeFH) or non-familial hypercholesterolaemia (non-FH). Results showed that alirocumab was well tolerated and resulted in a clinically significant reduction in low-density lipoprotein cholesterol (LDL-C).
Aim |
This ancillary analysis aimed to describe the characteristics of the French patients enrolled in the study, the main results observed in this population according to their familial hypercholesterolaemia status, and adherence to treatment.
Methods |
French data were analysed separately from the original dataset of the study.
Results |
Among 215 French patients in the ODYSSEY APPRISE trial, 63.7% had non-FH, with a mean LDL-C concentration of 5.0±1.8mmol/L at baseline. The mean duration of alirocumab exposure was 72.4±42.5 weeks, with only 48.4% of patients receiving statins concomitantly. At week 12, a mean reduction in LDL-C of 56.5±17.8% was observed: 51.2±22.8% in HeFH; 59.5±13.2% in non-FH. This improvement in LDL-C started from week 4 and remained stable and sustained until week 120 in both populations. The overall incidence of severe treatment-emergent adverse events (TEAEs) was 33.5%. The most frequent TEAEs were myalgia (15.8%) and asthenia (15.3%). No tolerance or efficacy differences were observed between patients with or without established coronary artery disease or other cardiovascular disease, whatever the age of these events or considering the concomitant use of other lipid-lowering therapies.
Conclusions |
In the French setting, alirocumab was well tolerated, safe and highly effective at reducing LDL-C. These findings support the use of alirocumab to manage hypercholesterolaemia in patients at high cardiovascular risk.
Le texte complet de cet article est disponible en PDF.Keywords : Hypercholesterolaemia, Cardiovascular risk, PCSK9 inhibitor, Real-life study, France
Abbreviations : CAD, CVD, HeFH, LDL-C, LLT, mITT, non-FH, PCSK9, TEAE
Plan
☆ | Tweet: An ancillary analysis of the ODYSSEY-APPRISE survey conducted in French patients has shown that alirocumab was well tolerated, safe and highly effective at reducing LDL-C. These findings support the use of alirocumab in patients at high cardiovascular risk. |
Vol 116 - N° 1
P. 3-8 - janvier 2023 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.