LDLc reduction with fixed-dose combination rosuvastatin-ezetimibe in patients with coronary heart disease that are not candidates for PCSK9 inhibitors treatment

Abstract

Abstract Background Statin plus ezetimibe combination has a recommendation class IIa, level of evidence B, for low-density lipoprotein cholesterol (LDLc) reduction. Since LDLc treatment target for patients with coronary heart disease (CHD) has been recently reduced to <55 mg/dl most patients might need lipid-lowering drugs combinations and fixed-dose combinations are known to increase adherence. Current indications for PCSK9 inhibitors accepted for reimbursement in Spain in patients with CHD are LDL >100 mg/dl despite maximal dose tolerated of statins or any of previous patients with statin intolerance and LDL >100 mg/dl. Methods Investigator-initiated retrospective analysis of patients with coronary heart disease that received fixed-dose combination with rosuvastatin-ezetimibe between 2019 and 2020 in a specialized unit for patients with CHD. Inclusion criteria were: CHD and LDLc <100 mg/dl despite statin treatment or >100 mg/dl without previous lipid-lowering treatments. We also analysed patients in whom treatment was initiated at discharge from and acute coronary syndrome (ACS) or with chronic coronary syndrome (CCS) Results We analyzed 137 patients, 79.4% males, mean age 62. (12.3) and 24.1% with ACS. Statin treatment before initiation fixed-dose combination was higher in patients with CCS (71.2% vs. 8.2%; p<0.01). Mean LDLc before treatment was 103.0 (30.5) mg/dl and it was higher in patients with ACS (121.3 (40.2) vs. 97.4 (24.4); p<0.001). Median time to second blood test was 203 days (IQR 122–300); mean post-treatment LDLc was 60.8 (21.2) mg/dl and no difference (p=0.18) was found in patients with ACS vs CCS: 56.0 (26.1) vs. 62.4 (19.2) mg/dl. Mean LDLc reduction was 38.5% and it was higher in was higher in ACS patients (49.9% vs. 34.7%) (figure). LDLc <55 mg/dl was achieved in 42.1% of the patients, more frequently in patients with ACS: 59.3% vs. 36.3% (p=0.036). No increase in transaminases was detected and a reduction in triglycerides was found (149.1 (100.4) to 124.7 (82.3) mg/dl; p=0.041). Conclusions Treatment with a fixed-dose combination with rosuvastatin-ezetimibe in patients with CHD not candidate for PCSK9 inhibitors is effective and safe for LDLc reduction especially in patients discharged after an ACS. Funding Acknowledgement Type of funding sources: None.