Inclisiran for LDL-C reduction in secondary prevention: Real-world evidence from a homogeneous Spanish cohort with subgroup insights.
Source: PubMed, NCBI / U.S. National Library of Medicine
Inclisiran produces sustained LDL-C lowering in clinical trials. Real-world evidence in homogeneous secondary prevention populations is limited. To evaluate the early effect of inclisiran on LDL-C in a homogeneous secondary prevention cohort with coronary artery disease. We conducted a retrospective, observational study of 120 adults with established atherosclerotic cardiovascular disease treated with inclisiran between December 2023 and August 2025 at a tertiary care center in Spain. Baseline and 90-day lipid profiles were compared. Subgroup analyses examined LDL-C reduction by sex, type 2 diabetes, statin, ezetimibe, and bempedoic acid use, as well as Lp(a) and remnant cholesterol (RC) levels. Mean baseline LDL-C was 126.1±34.7mg/dL (3.26±0.90mmol/L), decreasing to 45.3±28.3mg/dL (1.17±0.73mmol/L) at 90 days (absolute change -80.9mg/dL; -2.09mmol/L, -63.8%). The therapeutic target, <55mg/dL (<1.4mmol/L), was achieved by 64.5%. Statin users had significantly greater reductions (p<0.01). LDL-C lowering was similar across sexes despite higher baseline levels in women, and slightly greater in patients with diabetes (p=0.48). Elevated Lp(a) showed a weak inverse correlation with LDL-C change although a trend was shown (r=-0.18). RC fell by 16.6% (p=0.008). Bempedoic acid users (n=16) had numerically greater reductions, though not statistically significant probably due to the low n of patients. Inclisiran was well tolerated in this cohort, with no significant
Abstract
Inclisiran produces sustained LDL-C lowering in clinical trials. Real-world evidence in homogeneous secondary prevention populations is limited. To evaluate the early effect of inclisiran on LDL-C in a homogeneous secondary prevention cohort with coronary artery disease. We conducted a retrospective, observational study of 120 adults with established atherosclerotic cardiovascular disease treated with inclisiran between December 2023 and August 2025 at a tertiary care center in Spain. Baseline and 90-day lipid profiles were compared. Subgroup analyses examined LDL-C reduction by sex, type 2 diabetes, statin, ezetimibe, and bempedoic acid use, as well as Lp(a) and remnant cholesterol (RC) levels. Mean baseline LDL-C was 126.1±34.7mg/dL (3.26±0.90mmol/L), decreasing to 45.3±28.3mg/dL (1.17±0.73mmol/L) at 90 days (absolute change -80.9mg/dL; -2.09mmol/L, -63.8%). The therapeutic target, <55mg/dL (<1.4mmol/L), was achieved by 64.5%. Statin users had significantly greater reductions (p<0.01). LDL-C lowering was similar across sexes despite higher baseline levels in women, and slightly greater in patients with diabetes (p=0.48). Elevated Lp(a) showed a weak inverse correlation with LDL-C change although a trend was shown (r=-0.18). RC fell by 16.6% (p=0.008). Bempedoic acid users (n=16) had numerically greater reductions, though not statistically significant probably due to the low n of patients. Inclisiran was well tolerated in this cohort, with no significant adverse events reported. Inclisiran achieved marked LDL-C reductions at 90 days in real-world secondary prevention, especially with the concurrent use of statins. Its twice-yearly dosing and favorable safety profile, in the term observed, support integration into guideline-directed therapy. Larger, longer-term studies should assess durability of effect, long term adherence and the impact on cardiovascular outcomes.