Key result
Inclisiran and alirocumab/evolocumab effectively reduced LDL-C levels by 56.5% and 56.8% respectively at 3 months in patients with ASCVD (p<0.0001 for both).
Why the study?
To evaluate the effectiveness of PCSK9 inhibitors (alirocumab, inclisiran, and evolocumab) in patients with ASCVD failing to achieve target LDL-C levels.
Does inclisiran reduce LDL-C levels compared to other PCSK9 inhibitors in patients with ASCVD failing to achieve target LDL-C?
Observational (n=80)
Yes
Does inclisiran reduce LDL-C levels compared to other PCSK9 inhibitors in patients with ASCVD failing to achieve target LDL-C?
Absolute Event Rate: 56.5% vs 56.8%
p-value: p=<0.0001
In a real-world Moscow cohort, inclisiran demonstrated comparable short-term effectiveness to alirocumab and evolocumab in significantly reducing LDL-C levels in patients with ASCVD.
Comparable real-world LDL-C reductions support inclisiran as potential alternative; leaves open need for RCTs on outcomes and adherence.
Aim . To evaluate the effectiveness of PCSK9 inhibitors (alirocumab, inclisiran and evolocumab) in patients with atherosclerotic cardiovascular disease (ASCVD) and failure to achieve the target low-density lipoprotein cholesterol (LDL-C) level for the period from November 21, 2022 to December 31, 2023. Material and methods . For the observational study, 50 patients were included in the inclisiran therapy group and 30 patients in the control group (patients with ASCVD receiving PCSK9 inhibitors (alirocumab, n=1; evolocumab, n=29)). All study participants had their anamnestic data analyzed, and initially underwent electrocardiography, echocardiography, extracranial and lower limb Doppler ultrasound, and laboratory tests (complete blood count, biochemical blood tests, lipid profile). Three medical organizations of the Moscow State Healthcare System participate in the study. Results . Interim data are presented to evaluate the effectiveness of PCSK9 targeted therapy in patients with ASCVD, obtained 3 months from the study start. The comparison groups were comparable in main clinical characteristics. When analyzing the lipid-lowering effect of inclisiran in the examined patients with ASCVD, LDL-C level significantly decreased from 2,53±0,10 mmol/l to 110±0,08 mmol/l (by 56,5%), p<0,0001, while the target LDL-C level <1,4 mmol/l was achieved by 77,5% of the subjects. Analysis of the lipid-lowering effect of alirocumab/evolocumab showed a significant LDL-C decrease from 2,48±0,16 mmol/l to 1,07±0,11 mmol/l (by 56,8%), p<0,0001. Conclusion . The use of PCSK9 targeted therapy (alirocumab or inclisiran or evolocumab) in patients with ASCVD in Moscow make it possible to achieve target LDL-C levels, which are indicated in clinical guidelines, by 3 months.
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Sapina et al. (2023) conducted an observational in Atherosclerotic cardiovascular disease (ASCVD) (n=80). Inclisiran vs. Alirocumab or evolocumab was evaluated on LDL-C level decrease at 3 months (p=<0.0001). Inclisiran and alirocumab/evolocumab effectively reduced LDL-C levels by 56.5% and 56.8% respectively at 3 months in patients with ASCVD (p<0.0001 for both).
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