Abstract | OBJECTIVE: RESEARCH DESIGN AND METHODS: In DECLARE-TIMI 58, 17,160 patients with T2D and MRF (59.4%) or established ASCVD (40.6%) were randomized to dapagliflozin versus placebo; patients were followed for a median of 4.2 years. The cardiovascular and renal outcomes in the MRF cohort were studied across clinically relevant subgroups for treatment effect and subgroup-based treatment interaction. RESULTS: Among patients with MRF, the reduction with dapagliflozin in risk of cardiovascular death or hospitalization for heart failure (CVD/HHF) (hazard ratio [HR] 0.84, 95% CI 0.67-1.04) and the renal-specific outcome (HR 0.51, 95% CI 0.37-0.69) did not differ from that for patients with ASCVD (P interaction 0.99 and 0.72, respectively). The effect on CVD/HHF was entirely driven by a reduction in HHF (HR 0.64, 95% CI 0.46-0.88). The benefits of dapagliflozin on HHF and on the renal-specific outcome, among the subset with MRF, were directionally consistent across clinically relevant subgroups. At 48 months, HbA1c, weight, systolic blood pressure, and urinary albumin-to- creatinine ratio were lower with dapagliflozin versus placebo and estimated glomerular filtration rate was higher (P < 0.001). CONCLUSIONS: In patients with T2D and MRF, dapagliflozin reduced the risk of HHF and adverse renal outcomes regardless of baseline characteristics. These analyses support the benefit of dapagliflozin for important outcomes in a broad primary prevention population.
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Authors | Avivit Cahn, Itamar Raz, Lawrence A Leiter, Ofri Mosenzon, Sabina A Murphy, Erica L Goodrich, Ilan Yanuv, Aliza Rozenberg, Deepak L Bhatt, Darren K McGuire, John P H Wilding, Ingrid A M Gause-Nilsson, Anna Maria Langkilde, Marc S Sabatine, Stephen D Wiviott |
Journal | Diabetes care
(Diabetes Care)
Vol. 44
Issue 5
Pg. 1159-1167
(05 2021)
ISSN: 1935-5548 [Electronic] United States |
PMID | 33653824
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2021 by the American Diabetes Association. |
Chemical References |
- Benzhydryl Compounds
- Glucosides
- dapagliflozin
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Topics |
- Benzhydryl Compounds
(therapeutic use)
- Cardiovascular Diseases
(prevention & control)
- Diabetes Mellitus, Type 2
(drug therapy)
- Glucosides
(adverse effects)
- Heart Failure
- Humans
- Primary Prevention
- Treatment Outcome
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