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Baseline was measured after the lipid-stabilization period and prior to administration of first dose of study drug. Boxes indicate 25th and 75th percentiles; error bars indicate 5th and 95th percentiles. Within boxes, dots and horizontal lines indicate mean and median achieved LDL-C levels, respectively. Objective To evaluate the efficacy and tolerability of evolocumab when used in combination with a moderate- vs high-intensity statin. Design, Setting, and Patients Phase 3, week, randomized, double-blind, placebo- and ezetimibe-controlled study conducted between January and December of in patients with primary hypercholesterolemia and mixed dyslipidemia at sites in 17 countries.
Patients were initially randomized to a daily, moderate-intensity atorvastatin [10 mg], simvastatin [40 mg], or rosuvastatin [5 mg] or high-intensity atorvastatin [80 mg], rosuvastatin [40 mg] statin. Main Outcomes and Measures Percent change from baseline in low-density lipoprotein cholesterol LDL-C level at the mean of weeks 10 and 12 and at week Conclusions and Relevance In this week trial conducted among patients with primary hypercholesterolemia and mixed dyslipidemia, evolocumab added to moderate- or high-intensity statin therapy resulted in additional LDL-C lowering.
Further studies are needed to evaluate the longer-term clinical outcomes and safety of this approach for LDL-C lowering. Trial Registration clinicaltrials. Statin therapy reduces atherosclerotic cardiovascular disease events in proportion to the magnitude of low-density lipoprotein cholesterol LDL-C lowering. The addition of a nonstatin cholesterol-lowering drug also can be considered for patients with a less than anticipated LDL-C lowering response or for those unable to tolerate the recommended statin intensity.
At screening, intensive statin use was defined as daily atorvastatin 40 mg or greater , rosuvastatin 20 mg or greater , simvastatin 80 mg , or any statin plus ezetimibe. LAPLACE-2 was a week, randomized, double-blind, placebo- and ezetimibe-controlled, phase 3, multicenter study examining the efficacy and safety of evolocumab in combination with background statin therapy in patients with primary hypercholesterolemia and mixed dyslipidemia.
