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
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.