Evolocumab treatment in patients with HIV and hypercholesterolemia/mixed dyslipidemia: BEIJERINCK study design and baseline characteristics

Página do item simplificado
dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorBOCCARA, Franck
dc.contributor.authorKUMAR, Princy
dc.contributor.authorCARAMELLI, Bruno
dc.contributor.authorCALMY, Alexandra
dc.contributor.authorLOPEZ, J. Antonio G.
dc.contributor.authorBRAY, Sarah
dc.contributor.authorCYRILLE, Marcoli
dc.contributor.authorROSENSON, Robert S.
dc.date.accessioned2020-03-24T14:46:15Z
dc.date.available2020-03-24T14:46:15Z
dc.date.issued2020
dc.description.abstractBackground People living with human immunodeficiency virus (PLHIV) are at higher risk of atherosclerotic cardiovascular disease (ASCVD) due to traditional and HIV- or antiretroviral treatment (ART)-related risk factors. The use of high-intensity statin therapy is often limited by comorbidities and drug-drug interactions with ART. Herein, we present the design and baseline characteristics of the BEIJERINCK study, which will assess the safety and efficacy of evolocumab in PLHIV and hypercholesterolemia/mixed dyslipidemia. Methods Randomized, double-blind, placebo-controlled, multinational trial that investigates monthly subcutaneous evolocumab 420 mg versus placebo in PLHIV with hypercholesterolemia/mixed dyslipidemia who are treated with maximally-tolerated statin therapy. The primary outcome is the baseline to week 24 percent change in low density lipoprotein cholesterol (LDL-C). Secondary outcomes include achievement of LDL-C < 70 mg/dL and percent change in other plasma lipid and lipoprotein levels. Safety will also be examined. Results This study enrolled and dosed 464 patients who had a mean age of 56.4 years and were mostly male (82.5%). Mean duration with HIV was 17.4 years, and, by design, HIV viral load at screening was <= 50 copies/mL. ASCVD was documented in 35.6% of patients. Mean LDL-C of enrolled patients at baseline was 133.3 mg/dl. Statin use was prevalent (79.3% overall) with 74.6% receiving moderate or high-intensity statins. In total, 20.7% of patients did not receive statins due to intolerance/contraindications. Conclusions The BEUERINCK study is the first clinical trial to examine the lipid-lowering efficacy and safety of a fully human PCSK9 monoclonal antibody inhibitor in a moderate/high cardiovascular risk population of PLHIV.eng
dc.description.indexMEDLINEeng
dc.description.sponsorshipAmgen Inc.Amgen
dc.identifier.citationAMERICAN HEART JOURNAL, v.220, p.203-212, 2020
dc.identifier.doi10.1016/j.ahj.2019.11.004
dc.identifier.eissn1097-5330
dc.identifier.issn0002-8703
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/35424
dc.language.isoeng
dc.publisherMOSBY-ELSEVIEReng
dc.relation.ispartofAmerican Heart Journal
dc.rightsopenAccesseng
dc.rights.holderCopyright MOSBY-ELSEVIEReng
dc.subject.othercardiovascular-diseaseeng
dc.subject.otherstatin therapyeng
dc.subject.otherpcsk9eng
dc.subject.otherriskeng
dc.subject.otherindividualseng
dc.subject.othermanagementeng
dc.subject.otherlipoprotein(a)eng
dc.subject.otherinhibitorseng
dc.subject.otherinfectioneng
dc.subject.othertimeeng
dc.subject.wosCardiac & Cardiovascular Systemseng
dc.titleEvolocumab treatment in patients with HIV and hypercholesterolemia/mixed dyslipidemia: BEIJERINCK study design and baseline characteristicseng
dc.typearticleeng
dc.type.categoryoriginal articleeng
dc.type.versionpublishedVersioneng
dspace.entity.typePublication
hcfmusp.affiliation.countrySuíça
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryFrança
hcfmusp.affiliation.countryisofr
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisoch
hcfmusp.author.externalBOCCARA, Franck:Sorbonne Univ, Hop St Antoine, AP HP,Dept Cardiol, INSERM UMR S 938,Ctr Rech St Antoine,Hop Est Pari, Paris, France
hcfmusp.author.externalKUMAR, Princy:Georgetown Univ, Sch Med, Div Infect Dis & Travel Med, Washington, DC USA
hcfmusp.author.externalCALMY, Alexandra:Geneva Univ Hosp, Div Infect Dis, HIV AIDS Unit, Geneva, Switzerland
hcfmusp.author.externalLOPEZ, J. Antonio G.:Amgen Inc, Global Dev, Thousand Oaks, CA 91320 USA
hcfmusp.author.externalBRAY, Sarah:Amgen Inc, Global Dev, Thousand Oaks, CA 91320 USA
hcfmusp.author.externalCYRILLE, Marcoli:Amgen Inc, Global Dev, Thousand Oaks, CA 91320 USA
hcfmusp.author.externalROSENSON, Robert S.:Icahn Sch Med Mt Sinai, Cardiometabol Unit, Mt Sinai Heart, New York, NY 10029 USA
hcfmusp.citation.scopus6
hcfmusp.contributor.author-fmusphcBRUNO CARAMELLI
hcfmusp.description.beginpage203
hcfmusp.description.endpage212
hcfmusp.description.volume220
hcfmusp.origemWOS
hcfmusp.origem.pubmed31841795
hcfmusp.origem.scopus2-s2.0-85076244824
hcfmusp.origem.wosWOS:000510852400022
hcfmusp.publisher.cityNEW YORKeng
hcfmusp.publisher.countryUSAeng
hcfmusp.relation.referenceAberg JA, 2014, CLIN INFECT DIS, V58, pE1, DOI 10.1093/cid/cit665eng
hcfmusp.relation.referenceAustin MA, 2004, AM J EPIDEMIOL, V160, P407, DOI 10.1093/aje/kwh236eng
hcfmusp.relation.referenceBalde A, 2019, PLOS ONE, V14, DOI 10.1371/journal.pone.0210253eng
hcfmusp.relation.referenceBoccara F, 2017, AIDS, V31, P2367, DOI 10.1097/QAD.0000000000001633eng
hcfmusp.relation.referenceBoccara F, 2017, AM HEART J, V183, P91, DOI 10.1016/j.ahj.2016.10.013eng
hcfmusp.relation.referenceBoccara F, 2013, J AM COLL CARDIOL, V61, P511, DOI 10.1016/j.jacc.2012.06.063eng
hcfmusp.relation.referenceBurkholder GA, 2018, J CLIN LIPIDOL, V12, P988, DOI 10.1016/j.jacl.2018.03.082eng
hcfmusp.relation.referenceChastain DB, 2017, J CLIN TRANSL ENDOCR, V8, P6, DOI 10.1016/j.jcte.2017.01.004eng
hcfmusp.relation.referenceConroy RM, 2003, EUR HEART J, V24, P987, DOI 10.1016/S0195-668X(03)00114-3eng
hcfmusp.relation.referenceEnkhmaa B, 2018, J LIPID RES, V59, P1967, DOI 10.1194/jlr.P084517eng
hcfmusp.relation.referenceEnkhmaa B, 2017, ARTERIOSCL THROM VAS, V37, P997, DOI 10.1161/ATVBAHA.117.309137eng
hcfmusp.relation.referenceEnkhmaa B, 2013, ARTERIOSCL THROM VAS, V33, P387, DOI 10.1161/ATVBAHA.112.300125eng
hcfmusp.relation.referenceFeinstein MJ, 2019, CIRCULATION, V140, pE98, DOI 10.1161/CIR.0000000000000695eng
hcfmusp.relation.referenceFeinstein MJ, 2015, AM J CARDIOL, V115, P1760, DOI 10.1016/j.amjcard.2015.03.025eng
hcfmusp.relation.referenceGencer B, 2019, ATHEROSCLEROSIS, V284, P253, DOI 10.1016/j.atherosclerosis.2019.02.015eng
hcfmusp.relation.referenceGrundy SM, 2019, CIRCULATION, V139, pE1082, DOI 10.1161/CIR.0000000000000625eng
hcfmusp.relation.referenceKlein DB, 2015, CLIN INFECT DIS, V60, P1278, DOI 10.1093/cid/civ014eng
hcfmusp.relation.referenceKohli P, 2016, J AM HEART ASSOC, V5eng
hcfmusp.relation.referenceLabonte P, 2009, HEPATOLOGY, V50, P17, DOI 10.1002/hep.22911eng
hcfmusp.relation.referenceLake JE, 2013, LANCET INFECT DIS, V13, P964, DOI 10.1016/S1473-3099(13)70271-8eng
hcfmusp.relation.referenceLe QT, 2015, J BIOL CHEM, V290, P23385, DOI 10.1074/jbc.M115.642991eng
hcfmusp.relation.referenceLeucker TM, 2018, J AM HEART ASSOC, V7, DOI 10.1161/JAHA.118.009996eng
hcfmusp.relation.referenceMACH F, 2019, EUR HEART J, V2019eng
hcfmusp.relation.referenceMyerson M, 2015, J CLIN PHARMACOL, V55, P957, DOI 10.1002/jcph.473eng
hcfmusp.relation.referenceNou E, 2016, LANCET DIABETES ENDO, V4, P598, DOI 10.1016/S2213-8587(15)00388-5eng
hcfmusp.relation.referenceProto JD, 2018, J CLIN INVEST, V128, P2370, DOI 10.1172/JCI97785eng
hcfmusp.relation.referenceRasmussen LD, 2015, LANCET HIV, V2, pE288, DOI 10.1016/S2352-3018(15)00077-6eng
hcfmusp.relation.referenceRosenson RS, 2019, CIRC RES, V124, P364, DOI 10.1161/CIRCRESAHA.118.313238eng
hcfmusp.relation.referenceRosenson RS, 2018, J AM HEART ASSOC, V7, DOI [10.1161/JAHA.118.010345, 10.1161/jaha.118.010345]eng
hcfmusp.relation.referenceRosenson RS, 2017, J AM COLL CARDIOL, V70, P1290, DOI 10.1016/j.jacc.2017.07.752eng
hcfmusp.relation.referenceSabatine MS, 2017, NEW ENGL J MED, V376, P1713, DOI 10.1056/NEJMoa1615664eng
hcfmusp.relation.referenceShah ASV, 2018, CIRCULATION, V138, P1100, DOI 10.1161/CIRCULATIONAHA.117.033369eng
hcfmusp.relation.referenceStoekenbroek RM, 2018, NAT REV ENDOCRINOL, V15, P52, DOI 10.1038/s41574-018-0110-5eng
hcfmusp.relation.referenceWare D, 2018, PLOS ONE, V13, DOI 10.1371/journal.pone.0203890eng
hcfmusp.relation.referenceWilson PWF, 1998, CIRCULATION, V97, P1837, DOI 10.1161/01.CIR.97.18.1837eng
hcfmusp.relation.referenceZanni MV, 2017, OPEN FORUM INFECT DI, V4, DOI 10.1093/ofid/ofx227eng
hcfmusp.scopus.lastupdate2024-05-10
relation.isAuthorOfPublication0874df84-3783-4ad0-a812-982a731ec038
relation.isAuthorOfPublication.latestForDiscovery0874df84-3783-4ad0-a812-982a731ec038
Arquivos
Pacote Original
Agora exibindo 1 - 1 de 1
Imagem de Miniatura
Nome:
art_BOCCARA_Evolocumab_treatment_in_patients_with_HIV_and_hypercholesterolemiamixed_2020.PDF
Tamanho:
437.41 KB
Formato:
Adobe Portable Document Format
Descrição:
publishedVersion (English)
Baixar
Coleções
Artigos e Materiais de Revistas Científicas - FM/MCP
Artigos e Materiais de Revistas Científicas - HC/InCor
Artigos e Materiais de Revistas Científicas - ODS/03