Efficacy and Safety of Evolocumab in Reducing Low-Density Lipoprotein Cholesterol Levels in Chinese Patients with Non-ST-segment Elevation Acute Coronary Syndrome.

ABSTRACT

AIMS: This study aims to explore early intensive lipid-lowering therapy in patients with non- ST-segment elevation acute coronary syndrome (NSTE-ACS). BACKGROUND: Lowering low-density lipoprotein cholesterol (LDL-C) levels can reduce cardiovascular morbidity and mortality in patients with atherosclerotic cardiovascular disease. Due to many reasons, the need for early intensive lipid-lowering therapy is far from being met in Chinese NSTE-ACS patients at high risk of recurrent ischaemic events. OBJECTIVE: This study evaluates the feasibility, safety and efficacy of starting evolocumab in hospitals to lower LDL-C levels in Chinese patients with NSTE-ACS. METHODS: In this prospective cohort study initiated by researchers, 334 consecutive patients with NSTEACS who had sub-standard LDL-C levels (LDL-C ≥2.3 mmol/L after regular oral statin treatment for at least 4 weeks; or LDL-C ≥3.2 mmol/L without regular oral statin treatment) were included. Patients who agreed to treatment with evolocumab (140 mg subcutaneously every 2 weeks, initiated in hospital and used for 12 weeks after discharge) were enrolled in the evolocumab group (n=96) and others in the control group (n=238). All enrolled patients received regular statin treatment (atorvastatin 20 mg/day or rosuvastatin 10 mg/day; doses unchanged throughout the study). The primary endpoint was the change in LDL-C levels from baseline to week 12. RESULTS: Most patients (67.1%) had not received regular statin treatment before. In the evolocumab group, LDL-C levels decreased significantly at week 4 and remained stable at week 8 and 12 (all p<0.001). At week 12, the LDL-C percentage change from baseline in the evolocumab group was - 79.2±12.7% (from an average of 3.7 to 0.7 mmol/L), while in the control group, it was -37.4±15.4% (from an average of 3.3 to 2.0 mmol/L). The mean difference between these 2 groups was -41.8% (95% CI -45.0 to -38.5%; p<0.001). At week 12, the proportion of patients with LDL-C levels <1.8 mmol/L and 1.4 mmol/L in the evolocumab group was significantly higher than in the control group (96.8 vs 36.1%; 90.6 vs 7.1%; both p<0.001). The incidences of adverse events and cardiovascular events were similar in both the groups. CONCLUSION: In this prospective cohort study, we evaluated the early initiation of evolocumab in NSTEACS patients in China. Evolocumab combined with statins significantly lowered LDL-C levels and increased the probability of achieving recommended LDL-C levels, with satisfactory safety and good tolerance.