Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies

Erik Stroes; Jennifer G Robinson; Frederick J Raal; Robert Dufour; David Sullivan; Helina Kassahun; Yuhui Ma; Scott M Wasserman; Michael J Koren

doi:10.1002/clc.23049

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Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies

Journal article

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Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies

Erik Stroes, Jennifer G Robinson, Frederick J Raal, Robert Dufour, David Sullivan, Helina Kassahun, Yuhui Ma, Scott M Wasserman and Michael J Koren

Clinical cardiology (Mahwah, N.J.), Vol.41(10), pp.1328-1335

10/2018

DOI: 10.1002/clc.23049

PMCID: PMC6489970

PMID: 30120772

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Abstract

Evolocumab significantly lowers low-density lipoprotein cholesterol (LDL-C) when dosed 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) subcutaneously. LDL-C changes are comparable among different patient subgroups in a pooled analysis of data from phase 3 trials. A total of 3146 patients received ≥1 dose of evolocumab or control in four 12-week phase 3 studies. Percent change from baseline in LDL-C for evolocumab 140 mg Q2W or 420 mg QM vs control was reported as the average of week 10 and 12 values. Quantitative and qualitative interactions between treatment group and subgroup by dose regimen were tested. In the pooled analysis, treatment differences vs placebo or ezetimibe were similar for both 140 mg Q2W and 420 mg QM doses across ages (<65 years, ≥65 years); gender; race (Asian, black, white, other); ethnicity (Hispanic, non-Hispanic); region (Europe, North America, Asia Pacific); glucose tolerance status (type 2 diabetes mellitus, metabolic syndrome, neither); National Cholesterol Education Program risk categories (high, moderately high, moderate, low); and European Society of Cardiology/European Atherosclerosis Society risk categories (very high, high, moderate, or low). Certain low-magnitude variations in LDL-C lowering among subgroups led to significant quantitative interaction P values that, when tested by qualitative interaction, were not significant. The incidences of adverse events were similar across groups treated with each evolocumab dosing regimen or control. Consistent reductions in LDL-C were observed in the evolocumab group regardless of demographic and disease characteristics.

Hypercholesterolemia - blood

Double-Blind Method

Follow-Up Studies

Humans

Middle Aged

Europe - epidemiology

Male

Treatment Outcome

Hypercholesterolemia - drug therapy

Incidence

Dose-Response Relationship, Drug

Antibodies, Monoclonal, Humanized

Asia - epidemiology

Time Factors

Antibodies, Monoclonal - administration & dosage

Anticholesteremic Agents - administration & dosage

Injections, Subcutaneous

Cholesterol, LDL - blood

Female

Aged

North America - epidemiology

Hypercholesterolemia - epidemiology

Details

Title: Subtitle: Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies
Creators: Erik Stroes - Department of Vascular Medicine, Academic Medical Center of Amsterdam, Amsterdam, Netherlands
Jennifer G Robinson - Departments of Epidemiology and Medicine, University of Iowa, Iowa City, Iowa
Frederick J Raal - Department of Medicine, University of the Witwatersrand, Faculty of Health Sciences, Johannesburg, South Africa
Robert Dufour - Institut de recherches cliniques de Montréal, Université de Montréal, Montreal, Canada
David Sullivan - Royal Prince Alfred Hospital
Helina Kassahun - Amgen Inc., Thousand Oaks, California
Yuhui Ma - Amgen Inc., Thousand Oaks, California
Scott M Wasserman - Amgen Inc., Thousand Oaks, California
Michael J Koren - Jacksonville Center for Clinical Research, Jacksonville, Florida
Resource Type: Journal article
Publication Details: Clinical cardiology (Mahwah, N.J.), Vol.41(10), pp.1328-1335
DOI: 10.1002/clc.23049
PMID: 30120772
PMCID: PMC6489970
NLM abbreviation: Clin Cardiol
ISSN: 0160-9289
eISSN: 1932-8737
Publisher: United States
Grant note: Amgen Inc.
Language: English
Date published: 10/2018
Academic Unit: Epidemiology; Internal Medicine
Record Identifier: 9983995053102771

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