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Background and Importance Inclisiran is a small interfering (siRNA) that inhibits hepatic PCSK9 synthesis, thereby increasing LDL-C uptake. Its main advantage over anti-PCSK9 monoclonal antibodies is its long duration of action, requiring only two injections per year after initial dose. According clinical trials, it achieved a 28% to 55% reduction in LDL-C at 180 days compared to baselineAim and Objectives To evaluate the effectiveness and safety of inclisiran in adults with primary hypercholesterolaemia (heterozygous familial or non-familial) or mixed dyslipidemia in clinical practiceMaterial and Methods This retrospective observational study involved patients treated with inclisiran from January 2020 to January 2025 at a tertiary hospital. Data collected: age, sex, lipid parameters (LDL, total cholesterol, non-HDL, triglycerides, atherogenic index, ApoB and HDL), cardiovascular events, concomitant therapies, and adverse events. Data were obtained from electronic health records and dispensing software (Glintt HealthCare )Results 54 patients (mean age 63.2±11.00 years; 63.46% male) with non-familial/mixed (75.96%) or familial hypercholesterolaemia were treated with inclisiran. The median baseline values of lipid parameters were: LDL 108.75[130.25-84.45]mg/dL, total cholesterol 184.05[210.75-155.70]mg/dL, non-HDL cholesterol 131.55[170.3-111.3]mg/dL, triglycerides 117[174.25-84.75] mg/dL, atherogenic index 3.63[5.01-3.1], ApoB 89.75[120.08-77.53]mg/dL, and HDL 49.15[59.88-40.13]mg/dL. After the first dose, median values decreased to: LDL 55.25[86.78-30.6]mg/dL, total cholesterol 127.4[176.5-105.88]mg/dL, non-HDL 78.20[114.38-51.40] mg/dL, triglycerides 106[140-71.75] mg/dL, atherogenic index 2.45[30.2-2.11], ApoB 61.6[81.38-49.63] mg/dL, and HDL increased to 49.9[62.45-44.2] mg/dL. After the second dose, reduced to: LDL 47.85[74.33-24.33] mg/dL, total cholesterol 126.7[151.48-111.61] mg/dL, non-HDL 74.70[102.73-47.83] mg/dL, triglycerides to 97[129.25-74.5] mg/dL, atherogenic index 2.30[3-2], ApoB to 57.7 [70.95-40.8] mg/dL,and HDL increased to 53.43[62-39.9] mg/dL. 52 patients continued treatment, 2 discontinued for lack of efficacy. No cardiovascular events occurred during follow-up, 84.6% received concomitant lipid-lowering therapy, and no adverse effects related to drug administration were reported.Conclusion and Relevance Inclisiran produced a sustained 49–56% reduction in LDL-C in our patients in clinical practice, along with decreases in ApoB, total cholesterol, and atherogenic index, with a slight increase in HDL. No cardiovascular events occurred, discontinuation due to lack of efficacy was low, and no drug-related adverse effects were reported, supporting its safety and tolerability, Overall efficacy was 96.3%, confirming inclisiran as an effective option for high cardiovascular risk patients.References and/or Acknowledgements Clinical trial phase II ORION-1Conflict of Interest No conflict of interest