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External validity of type 2 diabetes clinical trials on cardiovascular outcomes for a multimorbid population.
Lazar Neto, Felippe; Mendes, Thiago Bosco; Matos, Paulo Marcelo Pontes Gomes; de Oliveira, Julio César; Favarato, Maria Helena Sampaio; Lin, Chin An; Martins, Milton Arruda.
Afiliação
  • Lazar Neto F; Department of Internal Medicin, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo, Brazil.
  • Mendes TB; Department of Internal Medicine, Faculdade de Medicina da Universidade Estadual de São Paulo (UNESP), São Paulo, Brazil.
  • Matos PMPG; Department of Internal Medicin, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo, Brazil.
  • de Oliveira JC; Department of Internal Medicin, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo, Brazil.
  • Favarato MHS; Department of Internal Medicin, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo, Brazil.
  • Lin CA; Department of Internal Medicin, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo, Brazil.
  • Martins MA; Department of Internal Medicin, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo, Brazil.
Diabetes Obes Metab ; 23(4): 971-979, 2021 04.
Article em En | MEDLINE | ID: mdl-33336870
AIM: To investigate the external validity of recent antihyperglycaemic trials evaluating cardiovascular outcomes in a multimorbid population. MATERIALS AND METHODS: Selection criteria of 15 randomized controlled trials from the 2020 American Diabetes Association Standard of Care statement were applied in a stepwise manner to tertiary care patients with type 2 diabetes. Primary outcomes were the number of patients eligible per individual trial and for the aggregate of trials. Secondary outcomes included patient predictors of trial eligibility. RESULTS: Of 1059 patients, the mean (SD) age was 66 (10.74) years, the median (IQR) Charlson index was 2 (2, 3) and 458 (43%) had documented cardiovascular disease. The median (IQR) number of patients included in individual trials was 263 (174.25-308.75) and 795 (75.1%) of them were eligible for at least one trial. Among those 264 ineligible, 127 (48.1%) had an HbA1c level of 7% or less and no cardiovascular disease; 53.5% and 34.4% of the patients were eligible for two and three different classes of drugs, respectively. The strongest predictor of trial eligibility was cardiovascular disease (risk ratio 2.17, 95% CI 2.01-2.35). CONCLUSIONS: A considerable proportion of multimorbid patients would be eligible for recent antihyperglycaemic trials. This positive finding can be attributed to development guidance in diabetes trials and the different approach we took, in which we evaluated inclusion by trials as an aggregate.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Doenças Cardiovasculares / Sistema Cardiovascular / Diabetes Mellitus Tipo 2 Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Aged / Humans / Middle aged Idioma: En Revista: Diabetes Obes Metab Assunto da revista: ENDOCRINOLOGIA / METABOLISMO Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Doenças Cardiovasculares / Sistema Cardiovascular / Diabetes Mellitus Tipo 2 Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Aged / Humans / Middle aged Idioma: En Revista: Diabetes Obes Metab Assunto da revista: ENDOCRINOLOGIA / METABOLISMO Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido