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

<p><span><strong>Background</strong>:</span> <span>Statin alone or nonstatins as add-ons have been introduced to intensive low-density lipoprotein cholesterol (LDL-C) </span><span>lowering</span><span> 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</span><span>.</span></p> <p><span><strong>Methods</strong>:</span> <span>Three hundred patients at high CVD risk were randomly assigned to the statin group</span><span> (Rosuvastatin 20mg/d</span><span>), statin_EZ group</span> <span>(Rosuvastatin 10mg/d + ezetimibe </span><span>10mg/d</span><span>),  statin_pcsk group (Rosuvastatin </span><span>10mg/d</span><span> + alirocumab </span><span>75mg/2</span><span>weeks) or combine3 group (Rosuvastatin 10mg/d + ezetimibe 10mg/d + alirocumab 75mg/2weeks)</span><span>.</span> <span>The primary outcome measure was cholesterol levels </span><span>(LDL-C, total cholesterol (TC) triglycerides (TGs), and high-density lipoprotein cholesterol (HDL-C))</span><span> after 24</span><span> weeks of</span><span> follow-up. The secondary outcome measures were safety markers and the proportion of patients who achieved the &lt; 70 mg/dL (1.8 mmol/L) LDL-C target. </span><span>A logistic</span><span> regression model was performed to explore the factors affecting lipid target achievement.</span></p> <p><span><strong>Results</strong>:</span> <span>The TC and LDL-C levels after treatment were significantly different among the four groups</span> <span>(p &lt; 0.05). The levels in both the combine3 group and </span><span>the </span><span>statin_pcsk9 group were significantly lower than </span><span>those in </span><span>the statin group and the statin_EZ group (</span><span>p &lt; 0.05</span><span>), but there was no significant difference between</span><span> the</span><span> combine3 group and </span><span>the </span><span>statin_pcsk9 group. The incidence of adverse events in the four groups was low.</span><span> Body mass index (BMI) and hypertensive status were related to target achievement.</span></p> <p><span><strong>Conclusion</strong>:</span><span> The combination of a statin</span><span> and a PCSK9 inhibitor was safe and more effective for the treatment of high-risk CVD patients, while the addition of </span><span>ezetimibe was</span><span> unable to significantly lower lipid levels any further. The rate of achieving </span><span>the </span><span>target was higher in patients </span><span>with</span><span> hypertension and a low BMI.</span></p>