International Variation in Outcomes Among People with Cardiovascular Disease or Cardiovascular Risk Factors and Impaired Glucose Tolerance: Insights from the NAVIGATOR Trial

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorSANTOS, Marilia Harumi Higuchi dos
dc.contributor.authorSHARMA, Abhinav
dc.contributor.authorSUN, Jie-Lena
dc.contributor.authorPIEPER, Karen
dc.contributor.authorMCMURRAY, John J. V.
dc.contributor.authorHOLMAN, Rury R.
dc.contributor.authorLOPES, Renato D.
dc.date.accessioned2017-04-07T15:13:22Z
dc.date.available2017-04-07T15:13:22Z
dc.date.issued2017
dc.description.abstractBackground-Regional differences in risk of diabetes mellitus and cardiovascular outcomes in people with impaired glucose tolerance are poorly characterized. Our objective was to evaluate regional variation in risk of new-onset diabetes mellitus, cardiovascular outcomes, and treatment effects in participants from the NAVIGATOR (Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research) trial. Methods and Results-NAVIGATOR randomized people with impaired glucose tolerance and cardiovascular risk factors or with established cardiovascular disease to valsartan (or placebo) and to nateglinide (or placebo) with a median 5-year follow-up. Data from the 9306 participants were categorized by 5 regions: Asia (n= 552); Europe (n= 4909); Latin America (n= 1406); North America (n= 2146); and Australia, New Zealand, and South Africa (n= 293). Analyzed outcomes included new-onset diabetes mellitus; cardiovascular death; a composite cardiovascular outcome of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke; and treatment effects of valsartan and nateglinide. Respective unadjusted 5-year risks for new-onset diabetes mellitus, cardiovascular death, and the composite cardiovascular outcome were 33%, 0.4%, and 4% for Asia; 34%, 2%, and 6% for Europe; 37%, 4%, and 8% for Latin America; 38%, 2%, and 6% for North America; and 32%, 4%, and 8% for Australia, New Zealand, and South Africa. After adjustment, compared with North America, European participants had a lower risk of new-onset diabetes mellitus (hazard ratio 0.86, 95% CI 0.78-0.94; P= 0.001), whereas Latin American participants had a higher risk of cardiovascular death (hazard ratio 2.68, 95% CI 1.82-3.96; P< 0.0001) and the composite cardiovascular outcome (hazard ratio 1.48, 95% CI 1.15-1.92; P= 0.003). No differential interactions between treatment and geographic location were identified. Conclusions-Major regional differences regarding the risk of new-onset diabetes mellitus and cardiovascular outcomes in NAVIGATOR participants were identified. These differences should be taken into account when planning global trials.
dc.description.indexMEDLINE
dc.description.sponsorshipNovartis Pharma
dc.identifier.citationJOURNAL OF THE AMERICAN HEART ASSOCIATION, v.6, n.1, article ID e003892, 11p, 2017
dc.identifier.doi10.1161/JAHA.116.003892
dc.identifier.issn2047-9980
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/18979
dc.language.isoeng
dc.publisherWILEY-BLACKWELL
dc.relation.ispartofJournal of the American Heart Association
dc.rightsopenAccess
dc.rights.holderCopyright WILEY-BLACKWELL
dc.subjectcardiovascular disease
dc.subjectdiabetes mellitus
dc.subjectrisk factor
dc.subject.othertype-2 diabetes-mellitus
dc.subject.otherlife-style intervention
dc.subject.otherfasting glucose
dc.subject.otherevents
dc.subject.otherprogression
dc.subject.otherprevention
dc.subject.othernateglinide
dc.subject.otherreduction
dc.subject.othervalsartan
dc.subject.othercohort
dc.subject.wosCardiac & Cardiovascular Systems
dc.titleInternational Variation in Outcomes Among People with Cardiovascular Disease or Cardiovascular Risk Factors and Impaired Glucose Tolerance: Insights from the NAVIGATOR Trial
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.affiliation.countryInglaterra
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryCanadá
hcfmusp.affiliation.countryEscócia
hcfmusp.affiliation.countryisoca
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisogb
hcfmusp.author.externalSHARMA, Abhinav:Duke Univ, Duke Clin Res Inst, Durham, NC USA; Univ Alberta, Mazankowski Alberta Heart Inst, Edmonton, AB, Canada
hcfmusp.author.externalSUN, Jie-Lena:Duke Univ, Duke Clin Res Inst, Durham, NC USA
hcfmusp.author.externalPIEPER, Karen:Duke Univ, Duke Clin Res Inst, Durham, NC USA
hcfmusp.author.externalMCMURRAY, John J. V.:Univ Cardiol, Western Infirm, Glasgow, Lanark, Scotland
hcfmusp.author.externalHOLMAN, Rury R.:Univ Oxford, Oxford Ctr Diabet Endocrinol & Metab, Diabet Trials Unit, Oxford, England
hcfmusp.author.externalLOPES, Renato D.:Duke Univ, Duke Clin Res Inst, Durham, NC USA
hcfmusp.citation.scopus5
hcfmusp.contributor.author-fmusphcMARILIA HARUMI HIGUCHI DOS SANTOS
hcfmusp.description.articlenumbere003892
hcfmusp.description.issue1
hcfmusp.description.volume6
hcfmusp.origemWOS
hcfmusp.origem.pubmed28087508
hcfmusp.origem.scopus2-s2.0-85009961979
hcfmusp.origem.wosWOS:000393593300012
hcfmusp.publisher.cityHOBOKEN
hcfmusp.publisher.countryUSA
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