Conditions: Dyslipidemia
Keywords: High cholesterol Treatment for high cholesterol Lowering cholesterol Lowering high cholesterol Hypercholesterolemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1974
Healthy volunteers: no

Brief summary:
This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.

Detailed description:
Participants who were enrolled in study 20110118 (FOURIER; NCT01764633) at select sites in select countries (selected based on study start-up timelines) were invited to participate in this cognitive function study, 20130385. There was no separate randomization for Study 20130385; data were analyzed according to Study 20110118 randomized treatment arm.

Arms:
arm 1: Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. Participants continued with their background statin therapy during the course of the study. arm 2: Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference. Participants continued with their background statin therapy during the course of the study.

Interventions: intervention 1: Evolocumab intervention 2: Placebo intervention 3: Background Statin Therapy
Intervention descriptions: intervention 1: Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen. intervention 2: Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen. intervention 3: Participants were required to be on a stable, high- to moderate-intensity statin background therapy consisting of an effective statin dose, ie, at least atorvastatin 20 mg daily or equivalent, and where locally approved, highly effective statin therapy (defined as at least atorvastatin 40 mg daily or equivalent) was recommended.

Protocol document: