Journal
DIABETES CARE
Volume 45, Issue 4, Pages 938-946Publisher
AMER DIABETES ASSOC
DOI: 10.2337/dc21-1744
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Funding
- AstraZeneca
- Bristol-Myers Squibb
- TIMI Study Group
- Hadassah Medical Organization
- Novo Nordisk
- Sanofi Aventis
- Amgen
- Arena
- Daiichi Sankyo
- Eisai
- Eli Lilly
- Janssen
- Merck
- Brigham and Women's Hospital from Abbott
- Aralez
- Bayer
- GlaxoSmithKline
- Intarcia
- MedImmune
- Novartis
- Pfizer
- Poxel
- Quark Pharmaceuticals
- Roche
- Takeda
- Medicines Company
- Zora Biosciences
- Abbott
- Edwards
- Boehringer Ingelheim
- CSL Behring
- Ferring Pharmaceuticals
- Afimmune
- Amarin
- Cardax
- CellProthera
- Cereno Scientific
- Chiesi
- Ethicon
- Faraday Pharmaceuticals
- Forest Laboratories
- Fractyl
- Garmin
- HLS Therapeutics
- Idorsia
- Ironwood
- Ischemix
- Lexicon
- Medtronic
- MyoKardia
- NirvaMed
- Owkin
- PhaseBio
- PLx Pharma
- Regeneron
- Sanofi
- Stasys
- Synaptic
- 89Bio
- Servier
- Anthos Therapeutics
- Daiichi-Sankyo
- IONIS
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Higher baseline HbA(1c) levels are associated with increased risks of cardiovascular and renal outcomes, particularly in the population with multiple risk factors (MRF). However, dapagliflozin showed benefits in reducing the risk of cardiovascular death/HHF, HHF, and cardiorenal outcomes across all subgroups regardless of baseline HbA(1c) levels.
OBJECTIVE Current guidelines recommend prescribing SGLT2 inhibitors to patients with type 2 diabetes and established or at high risk for atherosclerotic cardiovascular disease (ASCVD), irrespective of HbA(1c) levels. We studied the association of HbA(1c) with cardiovascular and renal outcomes and whether the benefit of dapagliflozin varies by baseline HbA(1c). RESEARCH DESIGN AND METHODS In the Dapagliflozin Effect on Cardiovascular Events trial (DECLARE-TIMI 58), 17,160 patients with type 2 diabetes were randomly assigned to dapagliflozin or placebo for a median follow-up of 4.2 years. Cardiovascular and renal outcomes by baseline HbA(1c) in the overall population and with dapagliflozin versus placebo in HbA(1c) subgroups were studied by Cox regression models. RESULTS In the overall population, higher baseline HbA(1c) was associated with a higher risk of cardiovascular death or hospitalization for heart failure (HHF); major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, and ischemic stroke; and cardiorenal outcomes (adjusted hazard ratios 1.12 [95% CI 1.06-1.19], 1.08 [1.04-1.13], and 1.17 [1.11-1.24] per 1% higher level, respectively). Elevated HbA(1c) was associated with a greater increased risk for MACE and cardiorenal outcomes in patients with multiple risk factors (MRF) than in established ASCVD (P-interaction = 0.0064 and 0.0093, respectively). Compared with placebo, dapagliflozin decreased the risk of cardiovascular death/HHF, HHF, and cardiorenal outcomes, with no heterogeneity by baseline HbA(1c) (P-interaction > 0.05). CONCLUSIONS Higher HbA(1c) levels were associated with greater cardiovascular and renal risk, particularly in the MRF population, yet the benefits of dapagliflozin were observed in all subgroups irrespective of baseline HbA(1c), including patients with HbA(1c) <7%.
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