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4CPS-192 Effectiveness and safety of inclisiran in real clinical practice

ejhpharm · 2026-03-18 · canonical JSON source

21 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background and Importance Inclisiran is a chemically synthesised small interfering RNA that inhibits PCSK9 synthesis, increasing LDL receptor recycling and expression, which reduces circulating LDL cholesterol (LDL-C) levels. It is indicated for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia.Aim and Objectives To evaluate the effectiveness and safety of inclisiran in patients with primary hypercholesterolaemia or dyslipidaemia.Material and Methods Retrospective observational study that included all patients who received inclisiran treatment from January 2024 to April 2025. Variables analysed included sex, age, medical history, prior biologic therapy, number of doses administered, baseline LDL-C, LDL-C at the time of the last available laboratory test, concomitant lipid-lowering treatments, and adverse events. Data were collected from medical records and the hospital outpatient medication program.Results The study period was 16 months. A total of 38 patients were included: 81.6% (31) were male and 18.4% (7) were female. The mean age was 66 years, and the average number of doses administered during the study period was 2.6.26 patients were diagnosed with ischaemic heart disease, and three with familial hypercholesterolaemia. Prior to inclisiran, 11 patients (28.9%) had been treated with evolocumab and 2 patients (5.3%) with alirocumab.Concomitant treatments were as follows: 13 patients received statin+ezetimibe, 6 statin monotherapy, 5 bempedoic acid+ezetimibe, 4 received triple therapy with ezetimibe + statin + fenofibrate, 2 ezetimibe, 1 fenofibrate+statins, and 7 patients didn’t receive treatment with lipid-lowering agents.The mean baseline LDL-C was 101.7 mg/dL (SD: 51), and the mean LDL-C at the time of the last available blood test was 58.3 mg/dL (SD: 34), representing a mean reduction of 42.7%. These results are based on a sample of 31 patients, as follow-up LDL-C levels were not available for 7 patients.In terms of safety, only one patient experienced gastrointestinal intolerance after the first dose, leading to treatment discontinuation.Conclusion and Relevance Inclisiran showed substantial efficacy in reducing LDL-C levels with a mean LDL-C reduction of 42.7%. Most patients received concomitant statin-based therapy, either as monotherapy or in combination. The safety profile was favourable, with only one reported adverse event requiring treatment discontinuation. These findings support inclisiran as an effective and well tolerated therapeutic option for LDL-C control.Conflict of Interest No conflict of interest