EFFICACY AND SAFETY OF INCLISIRAN IN OUTPATIENTS WITH RECENT ACUTE CORONARY SYNDROME

Abstract Background Early and intensive low–density lipoprotein cholesterol (LDL–C) reduction after recent acute coronary syndrome (ACS) may reduce recurrent CV event risk. Aim To evaluate the efficacy in LDL–C lowering added to usual care, of inclisiran administrated in outpatient with recent ACS. Methods The routine data of 11 patients (8 M/3 F) with mean age 64 ± 5 years, scheduled to S. Giovanni Bosco Hospital (Naples) in follow–up after recent ACS, treated with usual lipid lowering therapy (LLT) (high efficacy statins at maximum tolerated dose and ezetimibe 10 mg) and inclisiran 284 mg prescribed according to clinical indications (LDL–C values ≥70 mg/dL), were analysed. The outpatient follow–up program after hospitalization provides a visit on day 30 after discharge, then after 3 months, continuing with six–monthly checks. All patients underwent lipid profile and CPK dosage at baseline and at 3 months after the start of therapy. Renal and hepatic function was also assessed. The efficacy of the drug was assessed by the reduction in LDL–C compared to baseline. In all patients at baseline and after 3 months, clinical examination and standard ECG, were performed. Statistical Analysis Normally distributed variables are presented as mean ± standard deviation (SD) and were compared by Student’s t–test for paired data. A p≤0.05 value was considered statistically significant. Results Median follow–up was 4,1± 1,1 months. At 3 months of treatment, compared to baseline, statistically significant differences were observed in LDL–C values (median LDL–C levels were 41±11 mg/dL vs baseline 86±9 mg/dL) (p ‹0.001). After 3 months of treatment, baseline LDL–C decreased by 35% and these levels were maintained over time, with a median LDL–C of 50 (48–53) mg/dL at 6 months (in 3 patients). In all patients, at 3 months after the start of therapy, no significant changes in creatinine, transaminase or CPK values ​​were observed. Conclusions Our data suggests that inclisiran 284 mg plus usual care is effectiveness in the management of patients with elevated LDL–C post–ACS despite receiving statin therapy. Certainly larger supporting studies are needed.