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Inclisiran for LDL-C reduction in secondary prevention: Real-world evidence from a homogeneous Spanish cohort with
Victoria Piro1, Elena Fuente2, Francisco Romano2
1Department of Cardiology and Cardiac Rehabilitation, Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain.
Insights
Inclisiran significantly lowered LDL-C by 63.8% in 90 days for secondary prevention patients. This real-world study highlights its effectiveness, especially when combined with statins, supporting its use in cardiovascular therapy.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Lipidology
Background:
- Inclisiran demonstrates sustained low-density lipoprotein cholesterol (LDL-C) reduction in clinical trials.
- Limited real-world data exists for inclisiran in homogeneous secondary prevention populations.
- Coronary artery disease patients require effective lipid-lowering strategies.
Purpose of the Study:
- To assess the early impact of inclisiran on LDL-C levels.
- To evaluate inclisiran's efficacy in a real-world cohort of secondary prevention patients with coronary artery disease.
Main Methods:
- Retrospective observational study of 120 adults with established atherosclerotic cardiovascular disease.
- Comparison of lipid profiles at baseline and 90 days post-inclisiran treatment.
- Subgroup analyses included sex, diabetes status, concomitant lipid-lowering therapies, Lp(a), and remnant cholesterol (RC).
Main Results:
- Mean LDL-C decreased from 126.1 mg/dL to 45.3 mg/dL at 90 days, a 63.8% reduction.
- 64.5% of patients achieved the therapeutic target of <55 mg/dL LDL-C.
- Significant LDL-C reduction was observed with concurrent statin use (p<0.01); RC levels decreased by 16.6% (p=0.008).
Conclusions:
- Inclisiran achieved substantial LDL-C reduction within 90 days in a real-world secondary prevention setting.
- Concurrent statin therapy enhanced inclisiran's LDL-C lowering effect.
- The favorable safety profile and dosing schedule support inclisiran's integration into guideline-directed cardiovascular therapy.
Background:
Inclisiran produces sustained LDL-C lowering in clinical trials. Real-world evidence in homogeneous secondary prevention populations is limited.
Objective:
To evaluate the early effect of inclisiran on LDL-C in a homogeneous secondary prevention cohort with coronary artery disease.
Methods:
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.
Results:
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.
Conclusions:
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.
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