The effectiveness and safety of intensive lipid-lowering with different Rosuvastatin-based regimens in patients at high risk: A nonblind, randomized, controlled trial
Xu, Yunhong; Liang, Hao (2023), The effectiveness and safety of intensive lipid-lowering with different Rosuvastatin-based regimens in patients at high risk: A nonblind, randomized, controlled trial, Dryad, Dataset, https://doi.org/10.5061/dryad.0rxwdbs4b
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 model was performed to explore the factors affecting lipid target achievement.
Results: The TC and LDL-C levels after treatment were significantly different among the four groups (p < 0.05). The levels in both the combine3 group and the statin_pcsk9 group were significantly lower than those in the statin group and the statin_EZ group (p < 0.05), but there was no significant difference between the combine3 group and the statin_pcsk9 group. The incidence of adverse events in the four groups was low. Body mass index (BMI) and hypertensive status were related to target achievement.
Conclusion: The combination of a statin and a PCSK9 inhibitor was safe and more effective for the treatment of high-risk CVD patients, while the addition of ezetimibe was unable to significantly lower lipid levels any further. The rate of achieving the target was higher in patients with hypertension and a low BMI.
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.
Third Affiliated Hospital of Guangzhou Medical University
Science and Technology Program of Hunan Province, Award: 2022RC1021