The effectiveness and safety of intensive lipid-lowering with different Rosuvastatin-based regimens in patients at high risk: A nonblind, randomized, controlled trial

Background: Statin alone or nonstatins as add-ons have been introduced to intensive low-density lipoprotein cholesterol (LDL-C) lowering therapy in patients at high cardiovascular disease (CVD) risk. The purpose of this study was to evaluate the effectiveness and safety of different statin-based regimens for patients at high risk.
Methods: Three hundred patients at high CVD risk were randomly assigned to the statin group (Rosuvastatin 20mg/d), statin_EZ group (Rosuvastatin 10mg/d + ezetimibe 10mg/d),  statin_pcsk group (Rosuvastatin 10mg/d + alirocumab 75mg/2weeks) or combine3 group (Rosuvastatin 10mg/d + ezetimibe 10mg/d + alirocumab 75mg/2weeks). The primary outcome measure was cholesterol levels (LDL-C, total cholesterol (TC) triglycerides (TGs), and high-density lipoprotein cholesterol (HDL-C)) after 24 weeks of follow-up. The secondary outcome measures were safety markers and the proportion of patients who achieved the < 70 mg/dL (1.8 mmol/L) LDL-C target. A logistic regression ..., Laboratory tests, including tests for lipid levels (LDL-C, total cholesterol (TC) triglycerides (TGs), and high-density lipoprotein cholesterol (HDL-C)), liver and renal function tests, and creatine kinase (CK) tests, were conducted prior to the treatment and at the 12th week and 24th week. Information on sex, age, smoking history, hypertension, diabetes history, body mass index (BMI) and other related medical history was collected. The patients were followed up for 24 weeks.,