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  • 1
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    Relationship between baseline cardiac biomarkers and cardiovascular death or hospitalization for heart failure with and without sodium–glucose co‐transporter 2 inhibitor therapy in DECLARE‐TIMI 58
    Wiley ; 2021
    In:  European Journal of Heart Failure Vol. 23, No. 6 ( 2021-06), p. 1026-1036
    Details
    In: European Journal of Heart Failure, Wiley, Vol. 23, No. 6 ( 2021-06), p. 1026-1036
    Abstract: Dapagliflozin reduced the risk of the composite of cardiovascular (CV) death or hospitalization for heart failure (HHF) in patients with type 2 diabetes mellitus in DECLARE‐TIMI 58. We hypothesized that baseline N‐terminal pro B‐type natriuretic peptide (NT‐proBNP) and high‐sensitivity troponin T (hsTnT) levels would help identify patients who are at higher baseline risk and we describe the treatment effects of dapagliflozin in patients according to their baseline NT‐proBNP and hsTnT levels. Methods and results This was a pre‐specified biomarker study from DECLARE‐TIMI 58, a randomized, double‐blind, placebo‐controlled CV outcomes trial of dapagliflozin. Baseline NT‐proBNP and hsTnT levels were measured in the TIMI Clinical Trials Laboratory in 14 565 patients. Among the included patients, 9143 patients (62.8%) were male, 1464 (10.1%) had a history of heart failure and the mean age was 63.9 years. The median baseline NT‐proBNP and hsTnT levels were 75 pg/mL [interquartile range (IQR) 35–165] and 10.2 pg/mL (IQR 6.9–15.5), respectively. Patients with higher NT‐proBNP and hsTnT quartiles had higher rates of CV death/HHF (Q4 vs. Q1: NT‐proBNP: 4‐year Kaplan–Meier event rates 13.7% vs. 1.0%; hsTnT: 11.8% vs. 1.4%; P ‐trend 〈 0.001). Dapagliflozin consistently reduced the relative risk of CV death/HHF regardless of baseline NT‐proBNP ( P ‐interaction 0.72) or hsTnT quartiles ( P ‐interaction 0.93). Given their higher baseline risk, patients with NT‐proBNP and/or hsTnT levels above the median derived larger absolute risk reductions with dapagliflozin (NT‐proBNP 1.9% vs. 0%, P ‐interaction 0.010; hsTnT 1.8% vs. 0.1%, P ‐interaction 0.026). Conclusion Patients with type 2 diabetes mellitus and higher NT‐proBNP or hsTnT levels are at increased risk of CV death and HHF. Dapagliflozin reduced the relative risk of CV death/HHF irrespective of NT‐proBNP and hsTnT levels, with greater absolute risk reductions seen in patients with higher baseline biomarker levels.
    Type of Medium: Online Resource
    ISSN: 1388-9842 , 1879-0844
    URL: Issue
    URL: Article
    DOI: 10.1002/ejhf.v23.6
    DOI: 10.1002/ejhf.2073
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 1500332-2
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  • 2
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    Safety of dapagliflozin in a broad population of patients with type 2 diabetes: Analyses from the DECLARE‐TIMI 58 study
    Wiley ; 2020
    In:  Diabetes, Obesity and Metabolism Vol. 22, No. 8 ( 2020-08), p. 1357-1368
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    In: Diabetes, Obesity and Metabolism, Wiley, Vol. 22, No. 8 ( 2020-08), p. 1357-1368
    Abstract: To evaluate comprehensively the safety of dapagliflozin in patients with type 2 diabetes (T2DM), with emphasis placed on potential safety concerns related to the sodium‐glucose co‐transporter‐2 inhibitor class. Methods In the Dapagliflozin Effect on Cardiovascular Events – Thrombolysis in Myocardial Infarction 58 (DECLARE‐TIMI 58) study, 17 160 patients with T2DM were randomized to dapagliflozin or placebo and followed for a median of 4.2 years. Safety was evaluated in 17 143 patients receiving at least one dose of study drug. Results Acute kidney injury occurred less frequently with dapagliflozin, and adverse events suggestive of volume depletion were balanced between treatment groups, both irrespective of baseline estimated glomerular filtration rate, blood pressure, diuretic or loop diuretic use (interaction P values 〉 0.05). Fractures and malignancies were balanced between the groups, irrespective of sex, diabetes duration or smoking (interaction P values 〉 0.05) and fewer cases of bladder cancer occurred in the dapagliflozin versus the placebo group. Diabetic ketoacidosis was very rare, but more frequent with dapagliflozin versus placebo (27 vs. 12 patients with events; P = 0.02), yet signs, symptoms and contributing factors were similar in the two groups. Major hypoglycaemia occurred less frequently with dapagliflozin versus placebo, regardless of baseline use of either insulin or sulphonylureas (interaction P values 〉 0.05). There were more adverse events of genital infections leading to discontinuation of study drug in the dapagliflozin versus the placebo group, but serious genital infections were few and balanced between treatment groups. Urinary tract infections, acute pyelonephritis and urosepsis were also balanced between treatment groups. Conclusions Dapagliflozin was well tolerated. The long duration and large number of patient‐years in DECLARE‐TIMI 58 comprehensively addressed previous safety questions, confirming the robust safety profile of dapagliflozin.
    Type of Medium: Online Resource
    ISSN: 1462-8902 , 1463-1326
    URL: Issue
    URL: Article
    DOI: 10.1111/dom.v22.8
    DOI: 10.1111/dom.14041
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 2004918-3
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  • 3
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    Cardiorenal outcomes with dapagliflozin by baseline glucose‐lowering agents: Post hoc analyses from DECLARE‐TIMI 58
    Wiley ; 2021
    In:  Diabetes, Obesity and Metabolism Vol. 23, No. 1 ( 2021-01), p. 29-38
    Details
    In: Diabetes, Obesity and Metabolism, Wiley, Vol. 23, No. 1 ( 2021-01), p. 29-38
    Abstract: To assess the associations between baseline glucose‐lowering agents (GLAs) and cardiorenal outcomes with dapagliflozin versus placebo in the DECLARE‐TIMI 58 study. Materials and methods DECLARE‐TIMI 58 assessed the cardiorenal outcomes of dapagliflozin versus placebo in patients with type 2 diabetes. This post hoc analysis elaborates the efficacy and safety outcomes by baseline GLA for treatment effect and GLA‐based treatment interaction. Results At baseline, 14 068 patients (82.0%) used metformin, 7322 (42.7%) sulphonylureas, 2888 (16.8%) dipeptidyl peptidase‐4 inhibitors, 750 (4.4%) glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and 7013 (40.9%) insulin. Dapagliflozin reduced the composite of cardiovascular death (CVD) and hospitalization for heart failure (HHF) versus placebo regardless of baseline GLA, with greater benefit in the small group of patients with baseline use of GLP‐1 RAs (HR [95% CI] 0.37 [0.18, 0.78] vs. 0.86 [0.75, 0.98] in GLP‐1 RA users vs. non‐users, P interaction = .03). The overall HR for major adverse cardiovascular events (CVD, myocardial infarction or ischaemic stroke) was 0.93 (95% CI 0.84, 1.03) with dapagliflozin versus placebo, with no interaction by baseline GLA ( P interaction 〉  .05). The renal‐specific outcome was reduced with dapagliflozin versus placebo in the overall cohort (HR [95%CI] 0.53[0.43‐0.66] ), with no interaction by baseline GLA ( P interaction 〉  .05). All of these outcomes were similar in those with versus those without baseline metformin use. Conclusions The effects of dapagliflozin on cardiorenal outcomes were generally consistent regardless of baseline GLA, with consistent benefits regardless of baseline metformin use. The potential clinical benefit of combining sodium‐glucose co‐transporter‐2 inhibitors with GLP‐1 RAs, given some evidence of cardiovascular risk reduction with both classes, should be explored further.
    Type of Medium: Online Resource
    ISSN: 1462-8902 , 1463-1326
    URL: Issue
    URL: Article
    DOI: 10.1111/dom.v23.1
    DOI: 10.1111/dom.14179
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2004918-3
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  • 4
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    Cardiovascular and renal benefits of dapagliflozin in patients with short and long‐standing type 2 diabetes: Analysis from the DECLARE‐TIMI 58 trial
    Wiley ; 2020
    In:  Diabetes, Obesity and Metabolism Vol. 22, No. 7 ( 2020-07), p. 1122-1131
    Details
    In: Diabetes, Obesity and Metabolism, Wiley, Vol. 22, No. 7 ( 2020-07), p. 1122-1131
    Abstract: To investigate whether the cardiovascular and renal benefits observed with dapagliflozin in the DECLARE‐TIMI 58 trial are also observed in patients with short and long‐standing diabetes. Materials and Methods This post hoc analysis studied the dual primary efficacy endpoints, a composite of cardiovascular death or hospitalization for heart failure (CVD/HHF) and major adverse cardiovascular events (MACE; CVD, myocardial infarction [MI], ischaemic stroke) by diabetes duration. Results Of the 17 160 patients, 3836 had diabetes duration of ≤5 years, 4731 〉 5‐10 years, 3952 〉 10‐15 years, 2433 〉 15‐20 years and 2206 〉 20 years. Dapagliflozin reduced the risk of CVD/HHF by a similar amount across diabetes duration subgroups, ranging from HR 0.79 (0.58‐1.06) in patients with diabetes duration of ≤5 years to 0.75 (0.55‐1.03) in those patients with diabetes duration of 〉 20 years (interaction trend P ‐value 0.76). Hazard ratios (HRs) for MACE ranged from 1.08 (0.87‐1.35) in patients with diabetes duration of ≤5 years to 0.67 (0.52‐0.86) in those patients with diabetes duration of 〉 20 years (interaction trend P ‐value 0.004). This was driven by greater reductions in the risk of MI and ischaemic stroke with dapagliflozin in patients with long‐standing diabetes (interaction trend P ‐values 0.019 and 0.015, respectively). The duration‐based MACE heterogeneity was apparent in those with or without a history of prior MI and in those with multiple risk factors. The renal‐specific outcome was reduced with dapagliflozin with HRs ranging from 0.79 (0.47‐1.34) in patients with diabetes duration of ≤5 years to 0.42 (0.25‐0.72) in those patients with diabetes duration of 〉 20 years (interaction trend P ‐value 0.084). Conclusions Dapagliflozin reduced the risk of CVD/HHF consistently, regardless of diabetes duration, whereas the treatment effect for MACE differed by duration subgroups, with significant reductions with dapagliflozin in patients with long‐standing diabetes.
    Type of Medium: Online Resource
    ISSN: 1462-8902 , 1463-1326
    URL: Issue
    URL: Article
    DOI: 10.1111/dom.v22.7
    DOI: 10.1111/dom.14011
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 2004918-3
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  • 5
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    DECLARE‐TIMI 58: Participants’ baseline characteristics
    Wiley ; 2018
    In:  Diabetes, Obesity and Metabolism Vol. 20, No. 5 ( 2018-05), p. 1102-1110
    Details
    In: Diabetes, Obesity and Metabolism, Wiley, Vol. 20, No. 5 ( 2018-05), p. 1102-1110
    Abstract: To describe the baseline characteristics of participants randomized in the Dapagliflozin Effect on CardiovascuLAR Events (DECLARE‐TIMI 58) trial, the pivotal study conducted to assess cardiovascular (CV) outcomes with dapagliflozin. Methods The DECLARE‐TIMI 58 trial will analyse 17 160 patients with type 2 diabetes randomized to treatment with dapagliflozin (10 mg/d) or matching placebo. We analysed their baseline characteristics. Results The participants’ mean ± SD age was 63.8 ± 6.8 years, 62.6% were male, and their mean ± SD diabetes duration was 11.8 ± 7.8 years, glycated haemoglobin 8.3% ± 1.2% (67 mmol/mol ± 9.7 mmol/mol) and body mass index 32.1 ± 6.0 kg/m 2 . Randomization included 6971 (40.6%) patients with atherosclerotic CV disease (CVD), and 10 189 (59.4%) patients with multiple risk factors (MRF) for CVD (defined as men age ≥ 55 years or women ≥60 years, with at least one of dyslipidaemia, hypertension or smoking). Patients with CVD compared with patients with MRF were younger (62.5 ± 8.1 vs 64.7 ± 5.6 years), more frequently male (72.1% vs 56.1%), less often used metformin (74.6% vs 81.2%), more often used insulin (44.2% vs 36.4%), and more frequently used statins, aspirin, clopidogrel and β‐blockers (82.2%, 71.1%, 24.7% and 66.6% vs 63.7%, 39.1%, 1.5% and 32.3%, respectively). Conclusion The DECLARE‐TIMI 58 trial is expected to provide conclusive data on the effect of treatment with dapagliflozin in addition to standard of care, on CV outcomes in a broad patient population with type 2 diabetes and CVD or MRF for CVD.
    Type of Medium: Online Resource
    ISSN: 1462-8902 , 1463-1326
    URL: Issue
    URL: Article
    DOI: 10.1111/dom.2018.20.issue-5
    DOI: 10.1111/dom.13217
    Language: English
    Publisher: Wiley
    Publication Date: 2018
    detail.hit.zdb_id: 2004918-3
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