EFFECTIVENESS OF PCSK9 INHIBITOR TREATMENT IN VERY-HIGH CARDIOVASCULAR RISK PATIENTS

Background: The European Society of Cardiology guidelines stipulate a stringent LDLC target of < 1.4 mmol/L for individuals classified as very high risk. In instances where the therapeutic objective remains unattainable despite maximal statin and ezetimibe dosages, incorporating protein convertase subtilisin-kexin type 9(PCSK9) inhibitors is recommended as an adjunctive therapeutic strategy.
Aim: This study aimed to assess the long-term changes in LDLC levels among patients starting alirocumab therapy.
Method: The observational retrospective study was carried out from September 2023 to February 2024. The cohort comprised patients for whom alirocumab was prescribed having LDLC levels beyond 3.0 mmol/L despite undergoing statin and/or ezetimibe therapy at the highest tolerable dosage for a period longer than 3 months. Blood test results were collected at 1, 3, 6, and 12 months from PCSK9 inhibitor therapy initiation.
Results: Thirty-six patients were enrolled in the study, with 36.1% being women and 63.9% exhibiting statin intolerance. The cohort had an average LDLC level of 4.28 mmol/L before PCSK9 initiation. Out of 36 patients, 15 reached the target LDLC level with a mean value of1.88 mmol/L and 1.91 mmol/L after one month and three months. The proportion of patients achieving the target using mono, dual and triple therapy was 18.2% vs 41.7% vs 66.8% after one month and9.1% vs 58.3% vs 53.9% after three months, respectively. After 6 months, 11 of 17 observed patients achieved the target LDLC level, with a mean value of 1.57 mmol/L. After 12 months, only 2 out of the observed 7 patients reached the target LDLC level, with a mean value of 2.27 mmol/L. No difference in the number of patients achieving LDLC level targets was observed during all time points receiving mono, dual or triple therapy (p [0.050). Nevertheless, the mean LDLC values significantly decreased (p = 0.008). No adverse effects were reported by any patient.
Conclusion: Initiating alirocumab therapy, the mean values of LDLC significantly decreased. Nevertheless, results showed varying degrees of success in meeting the LDLC target across different therapy combinations and time points, suggesting that individual responses may differ depending on various factors.