{
  "abstract": "Background and Importance Inadequate control of LDL cholesterol persists in a considerable proportion of patients with dyslipidaemia despite intensive treatment with statins and ezetimibe. Inclisiran, a small interfering ribonucleic acid that inhibits hepatic synthesis of PCSK9, represents an innovative therapeutic alternative with a twice-yearly dosing schedule after the initial phase.Aim and Objectives To evaluate the effectiveness and safety of inclisiran in patients with primary hypercholesterolaemia or mixed dyslipidaemia in real-world clinical practice.Material and Methods A retrospective multicentre observational study including all patients who initiated treatment with inclisiran up to September 2025. Data collected in Excel included demographic variables, cardiovascular diagnosis, reason for initiation, previous use of PCSK9 inhibitors, statin intolerance, concomitant lipid-lowering therapies and adherence. The primary variables were the median and interquartile range (IQR) of percentage reduction from baseline in LDL cholesterol, total cholesterol, non-HDL cholesterol, HDL cholesterol and triglycerides at 90 and 270 days after treatment initiation. Safety was assessed through reported adverse events and treatment discontinuations. Adherence to concomitant lipid-lowering therapies was evaluated according to dispensing records. Data were obtained from electronic medical records and hospital pharmacy databases.Results A total of 63 patients were included (mean age 64 ± 11 years; 63% male). At 90 days, the reduction in LDL cholesterol was 36% (IQR 6–62) and at 270 days 39% (IQR 26–51). Total cholesterol decreased by 23% (IQR 0–42) and 24% (IQR 17–34), respectively. Non-HDL cholesterol was reduced by 33% (IQR 1–56) at 90 days and 36% (IQR 19–50) at 270 days. HDL cholesterol remained stable with minimal changes (3% (IQR 0–11) and 0% (IQR 0–9)). Triglycerides showed median reductions of 12% (IQR 0–29) at 90 days and 7% (IQR 0–22) at 270 days. No serious adverse events were reported; however, 8% (5/63) experienced local injection site reactions and 3% (2/63) discontinued treatment due to lack of effectiveness. Adherence to concomitant lipid-lowering therapies was >80% in 82% (52/63) of patients.Conclusion and Relevance Inclisiran was associated with reductions in LDL cholesterol and total cholesterol in real-world clinical practice, with an acceptable safety profile. Nevertheless, the magnitude of LDL cholesterol reduction was lower than that reported in pivotal clinical trials.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Ceuta University Hospital, Hospital Pharmacy, Ceuta, Spain"
      ],
      "name": "I Sánchez Lobón"
    },
    {
      "affiliations": [
        "Complejo Asistencial De Zamora, Hospital Pharmacy, Zamora, Spain"
      ],
      "name": "M Corralez Paz"
    },
    {
      "affiliations": [
        "Puerta Del Mar University Hospital, Hospital Pharmacy, Cádiz, Spain"
      ],
      "name": "M Dlá Ocaña De La Rosa"
    },
    {
      "affiliations": [
        "Complejo Asistencial De Zamora, Hospital Pharmacy, Zamora, Spain"
      ],
      "name": "Á Corral Alaejos"
    },
    {
      "affiliations": [
        "Complejo Asistencial De Zamora, Hospital Pharmacy, Zamora, Spain"
      ],
      "name": "S Fernandez Cañabate"
    }
  ],
  "title": "4CPS-056 Effectiveness and safety of inclisiran in real-world evidence: a multicentre experience in patients with primary hypercholesterolaemia or mixed dyslipidaemia",
  "uid": "d5cef565-0094-596c-be58-ad0b4bfe8cf4"
}