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Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus.
Berg, David D; Wiviott, Stephen D; Scirica, Benjamin M; Gurmu, Yared; Mosenzon, Ofri; Murphy, Sabina A; Bhatt, Deepak L; Leiter, Lawrence A; McGuire, Darren K; Wilding, John P H; Johanson, Per; Johansson, Peter A; Langkilde, Anna Maria; Raz, Itamar; Braunwald, Eugene; Sabatine, Marc S.
Afiliación
  • Berg DD; TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).
  • Wiviott SD; TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).
  • Scirica BM; TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).
  • Gurmu Y; TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).
  • Mosenzon O; Hadassah Hebrew University Hospital, Jerusalem, Israel (O.M., I.R.).
  • Murphy SA; TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).
  • Bhatt DL; TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).
  • Leiter LA; Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Canada (L.A.L.).
  • McGuire DK; University of Texas Southwestern Medical Center, Dallas (D.K.M.).
  • Wilding JPH; University of Liverpool, United Kingdom (J.P.H.W.).
  • Johanson P; AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).
  • Johansson PA; AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).
  • Langkilde AM; AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).
  • Raz I; Hadassah Hebrew University Hospital, Jerusalem, Israel (O.M., I.R.).
  • Braunwald E; TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).
  • Sabatine MS; TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).
Circulation ; 140(19): 1569-1577, 2019 11 05.
Article en En | MEDLINE | ID: mdl-31474116
ABSTRACT

BACKGROUND:

Patients with type 2 diabetes mellitus (T2DM) are at increased risk of developing heart failure. Sodium-glucose cotransporter-2 inhibitors reduce the risk of hospitalization for heart failure (HHF) in patients with T2DM. We aimed to develop and validate a practical clinical risk score for HHF in patients with T2DM and assess whether this score can identify high-risk patients with T2DM who have the greatest reduction in risk for HHF with a sodium-glucose cotransporter-2 inhibitor.

METHODS:

We developed a clinical risk score for HHF in 8212 patients with T2DM in the placebo arm of SAVOR-TIMI 53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients With Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53). Candidate variables were assessed using multivariable Cox regression, and independent clinical risk indicators achieving statistical significance of P<0.001 were included in the risk score. We externally validated the score in 8578 patients with T2DM in the placebo arm of DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58). The relative and absolute risk reductions in HHF with the sodium-glucose cotransporter-2 inhibitor dapagliflozin were assessed by baseline HHF risk.

RESULTS:

Five clinical variables were independent risk predictors of HHF prior heart failure, history of atrial fibrillation, coronary artery disease, estimated glomerular filtration rate, and urine albumin-to-creatinine ratio. A simple integer-based score (0-7 points) using these predictors identified a >20-fold gradient of HHF risk (P for trend <0.001) in both the derivation and validation cohorts, with C indices of 0.81 and 0.78, respectively. Although relative risk reductions with dapagliflozin were similar for patients across the risk scores (25%-34%), absolute risk reductions were greater in those at higher baseline risk (1-sided P for trend=0.04), with high-risk (2 points) and very-high-risk (≥3 points) patients having 1.5% and 2.7% absolute reductions in Kaplan-Meier estimates of HHF risk at 4 years, respectively.

CONCLUSIONS:

Risk stratification using a novel clinical risk score for HHF in patients with T2DM identifies patients at higher risk for HHF who derive greater absolute benefit from sodium-glucose cotransporter-2 inhibition. CLINICAL TRIAL REGISTRATION URL https//www.clinicaltrials.gov. Unique identifiers NCT01107886 and NCT01730534.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Compuestos de Bencidrilo / Técnicas de Apoyo para la Decisión / Diabetes Mellitus Tipo 2 / Cardiomiopatías Diabéticas / Inhibidores del Cotransportador de Sodio-Glucosa 2 / Glucósidos / Insuficiencia Cardíaca Tipo de estudio: Clinical_trials / Diagnostic_studies / Etiology_studies / Prognostic_studies / Risk_factors_studies Idioma: En Revista: Circulation Año: 2019 Tipo del documento: Article

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Compuestos de Bencidrilo / Técnicas de Apoyo para la Decisión / Diabetes Mellitus Tipo 2 / Cardiomiopatías Diabéticas / Inhibidores del Cotransportador de Sodio-Glucosa 2 / Glucósidos / Insuficiencia Cardíaca Tipo de estudio: Clinical_trials / Diagnostic_studies / Etiology_studies / Prognostic_studies / Risk_factors_studies Idioma: En Revista: Circulation Año: 2019 Tipo del documento: Article