Abstract:
Background The management and control of the lipid, especially the reduction of serum low density lipoprotein cholesterol (LDL-C) level plays an important role in patients with coronary heart disease. Evolocumab injection, a new lipid-lowering drug, has attracted more and more attention for its good effect and safety.
Objective To evaluate the efficacy and safety of evolocumab in the treatment of hyperlipidemia in patients with acute coronary syndrome.
Methods Patients with acute coronary syndrome who were hospitalized in the department of cardiology, the First Affiliated Hospital of Naval Military Medical University from July 2020 to June 2021 and whose low density lipoprotein cholesterol (LDL-C) did not reach the target (>1.4 mmol/L) were included. They were randomly divided into the conventional treatment group (atorvastatin 20 mg or rosuvastatin 10 mg once a night) and the combined treatment group (atorvastatin 20 mg or rosuvastatin 10 mg once a night & evolocumab 140 mg once two weeks), with 42 patients in each group, and the treatment lasted for 3 months. The changes of circulating blood lipid levels and the incidence of adverse events were compared between the two groups before and after treatment.
Results There were no significant differences in cardiovascular risk factors or lipid levels at baseline between the two groups (P>0.05). After 3 months of treatment, the levels of total cholesterol (TC), LDL-C, and apolipoprotein B (ApoB) in the two groups decreased significantly (P<0.05). And the level of TG in the combined treatment group also decreased significantly (P<0.05). The level of lipoprotein a (Lp(a)) increased in the conventional group while decreased in the combined treatment group, without statistically significant difference (P>0.05). Compared with the conventional treatment group, the combined treatment group had significantly greater decrease of TC, LDL-C, ApoB and Lp(a) (P<0.05), while a significantly higher control rate of LDL-C (P<0.05). No serious adverse event was observed in the two groups. The cumulative adverse reactions in the combined treatment group were significantly higher than those in the conventional treatment group (P<0.05), which was mainly related to subcutaneous injection reaction.
Conclusion For lipid management in patients with acute coronary syndrome, evolocumab combined with statin therapy can further reduce the levels of TC, LDL-C and ApoB, and reduce the levels of TG and Lp(a) to a certain extent, with good safety, which suggests that evolocumab is a very promising medicine.