Key result
Inclisiran lowers LDL-C by ~48% at 15 months in real-world cohort follow-up.
Why the study?
Inclisiran effectively lowers LDL-C in randomized trials, yet real-world clinical data on its efficacy and safety beyond 12 months are still limited.
Does inclisiran reduce LDL-C concentrations at 15 months in patients at high, very high, or extreme cardiovascular risk in clinical practice?
Cohort (n=240)
Yes
Does inclisiran reduce LDL-C concentrations at 15 months in patients at high, very high, or extreme cardiovascular risk in clinical practice?
In a real-world registry of high-risk patients, inclisiran provided significant and sustained LDL-C reductions (−47.5%) and good safety over 15 months, with enhanced target attainment when co-administered with statins.
Answers are grounded in this paper and cite their sources.
Supports real-world LDL-C lowering by inclisiran in high-risk patients; extends RCT data but leaves practice change open.
Background: Inclisiran, a long-acting siRNA targeting PCSK9 synthesis, effectively lowers LDL-C in randomized trials, yet real-world clinical data beyond 12 months are still limited. This study evaluated the efficacy and safety of inclisiran in clinical practice up to 15 months of follow-up. Methods: The INCLIVEN study is a multicenter observational retrospective registry across 12 lipid clinics in the Veneto region, Italy. Patients at high, very high, or extreme cardiovascular risk who started inclisiran between October 2022 and February 2024 were included. Primary endpoints included absolute and percentage reductions in LDL-C concentrations from baseline to 15 months, and safety. Results: A total of 240 patients were included in the analysis, with 218 (90.8%) completing the 15-month follow-up (mean age 64.0 years; 72.5% male; 87.9% with ASCVD history). At 15 months, mean LDL-C levels decreased from 118.7 ± 48.7 mg/dL to 60.3 ± 36.3 mg/dL (−47.5 ± 26.3%; p < 0.001). Overall, 56.9% of patients achieved their risk-adjusted LDL-C targets. Statin users demonstrated a higher target attainment rate compared to non-statin users (67.5% vs. 31.3%; p < 0.001). Multivariable analyses identified diabetes mellitus as an independent predictor for superior therapeutic response (−58.6 ± 20.7% vs. −43.8 ± 26.9%; p = 0.001). Inclisiran exhibited a good safety profile, with no serious adverse events documented. Conclusion: Inclisiran provided significant and sustained LDL-C reductions over 15 months. Statin co-administration improved target achievement, and lipid-lowering was enhanced in patients with diabetes. Favorable tolerability and treatment adherence support inclisiran as a reliable lipid-lowering treatment in high-risk populations.
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Sani et al. (2026) conducted a cohort in High, very high, or extreme cardiovascular risk requiring lipid-lowering therapy (n=240). Inclisiran was evaluated on Absolute and percentage reductions in LDL-C concentrations from baseline to 15 months, and safety (p=< 0.001). Inclisiran lowered mean LDL-C by 47.5% from 118.7 to 60.3 mg/dL at 15 months (p < 0.001), with 56.9% of patients achieving risk-adjusted LDL-C targets and no serious adverse events.
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