Rationale and design of LAPLACE-2: a phase 3, randomized, double-blind, placebo- and ezetimibe-controlled trial evaluating the efficacy and safety of evolocumab in subjects with hypercholesterolemia on background statin therapy

Jennifer G Robinson; William J Rogers; Bettina S Nedergaard; Jonathan Fialkow; Joel M Neutel; David Ramstad; Ransi Somaratne; Jason C Legg; Patric Nelson; Rob Scott; Scott M Wasserman; Robert Weiss

doi:10.1002/clc.22252

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Rationale and design of LAPLACE-2: a phase 3, randomized, double-blind, placebo- and ezetimibe-controlled trial evaluating the efficacy and safety of evolocumab in subjects with hypercholesterolemia on background statin therapy

Journal article

Open access

Rationale and design of LAPLACE-2: a phase 3, randomized, double-blind, placebo- and ezetimibe-controlled trial evaluating the efficacy and safety of evolocumab in subjects with hypercholesterolemia on background statin therapy

Jennifer G Robinson, William J Rogers, Bettina S Nedergaard, Jonathan Fialkow, Joel M Neutel, David Ramstad, Ransi Somaratne, Jason C Legg, Patric Nelson, Rob Scott, …

Clinical cardiology (Mahwah, N.J.), Vol.37(4), pp.195-203

04/2014

DOI: 10.1002/clc.22252

PMCID: PMC6649582

PMID: 24481874

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https://doi.org/10.1002/clc.22252View

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Abstract

Low-density lipoprotein cholesterol (LDL-C) levels are significantly associated with atherosclerotic cardiovascular disease (ASCVD) risk, and studies using interventions that lower LDL-C levels have been shown to reduce the risk of ASCVD events and mortality. Statin treatment is the current first-line therapy for lowering LDL-C and reducing ASCVD risk. However, many patients are still unable to reach recommended LDL-C goals on maximally tolerated statin therapy. Monoclonal antibodies that inhibit proprotein convertase subtilisin/kexin type 9, including evolocumab (previously AMG 145), dramatically lowered LDL-C in phase 2 clinical trials when administered alone or in combination with a statin. The aim of this phase 3 study is to evaluate the efficacy of 12 weeks of subcutaneous evolocumab (vs placebo) administered every 2 weeks or every month in combination with a statin in patients with hypercholesterolemia and mixed dyslipidemia. This study will also provide comparative efficacy, safety, and tolerability data between evolocumab and ezetimibe when added to background atorvastatin therapy.

Dyslipidemias - drug therapy

Double-Blind Method

Drug Administration Schedule

Humans

Middle Aged

Antibodies, Monoclonal - adverse effects

Azetidines - adverse effects

Ezetimibe

Antibodies, Monoclonal - therapeutic use

Male

Treatment Outcome

Hypercholesterolemia - drug therapy

Young Adult

Anticholesteremic Agents - therapeutic use

Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects

Azetidines - therapeutic use

Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use

Adolescent

Aged, 80 and over

Adult

Female

Aged

Drug Therapy, Combination

Details

Title: Subtitle: Rationale and design of LAPLACE-2: a phase 3, randomized, double-blind, placebo- and ezetimibe-controlled trial evaluating the efficacy and safety of evolocumab in subjects with hypercholesterolemia on background statin therapy
Creators: Jennifer G Robinson - Departments of Epidemiology and Medicine, College of Public Health, University of Iowa, Iowa, Iowa
William J Rogers
Bettina S Nedergaard
Jonathan Fialkow
Joel M Neutel
David Ramstad
Ransi Somaratne
Jason C Legg
Patric Nelson
Rob Scott
Scott M Wasserman
Robert Weiss - Amgen (United States)
Resource Type: Journal article
Publication Details: Clinical cardiology (Mahwah, N.J.), Vol.37(4), pp.195-203
DOI: 10.1002/clc.22252
PMID: 24481874
PMCID: PMC6649582
NLM abbreviation: Clin Cardiol
ISSN: 0160-9289
eISSN: 1932-8737
Publisher: United States
Language: English
Date published: 04/2014
Academic Unit: Epidemiology
Record Identifier: 9983996062702771

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