Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes
N Engl J Med
; 373(3): 232-242, 2015. ilus
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1064859
Biblioteca responsável:
BR79.1
Localização: BR79.1
ABSTRACT
BACKGROUND:
Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease.METHODS:
In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina.RESULTS:
During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to -0.27). Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years). Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P<0.001). Rates of hospitalization for heart failure did not differ between the two groups (hazard ratio, 1.00; 95% CI, 0.83 to 1.20; P=0.98). There were no significant between-group differences in rates of acute pancreatitis (P=0.07) or pancreatic cancer (P=0.32).
Texto completo:
Disponível
Coleções:
Bases de dados nacionais
/
Brasil
Base de dados:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Doenças Cardiovasculares
/
Diabetes Mellitus
/
Fosfato de Sitagliptina
Tipo de estudo:
Ensaio clínico controlado
/
Estudo de etiologia
Idioma:
Inglês
Revista:
N Engl J Med
Ano de publicação:
2015
Tipo de documento:
Artigo
Instituição/País de afiliação:
; Diabetes Trials Unit,Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford/GB
/
Canadian VIGOUR Centre, Universityof Alberta/CA
/
George Washington University Biostatistics Center/US
/
Instituto Dante Pazzanese de Cardiologia/BR
/
Merck/US
/
Munich Diabetes Research Group, Helmholtz Center/DE
/
St. Michaels Hospital, University ofToronto/CA
/
The Duke Clinical Research Institute,Duke University School of Medicine/US
/
University of Leuven/BE
/
University of North Carolina Schoolof Medicine/US