Publications
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Efficacy and Safety of the SGLT2 Inhibitor Empagliflozin versus Placebo and the DPP-4 Inhibitor Linagliptin versus Placebo in Young People with Type 2 Diabetes (DINAMO): a Multicentre, Randomised, Double-blind, Parallel Group, Phase 3 Trial
Lancet Diabetes Endocrinol. 2023; online ahead of print DOI: 10.1016/S2213-8587(22)00387-4
The incidence of T2D in young people is increasing, but treatments remain limited. The double-blind DINAMO trial was conducted in 158 young people (aged 10−17 years) with T2D (HbA1c 6.5-10.5%) who had been previously treated with metformin or insulin. Participants were initially randomised to empagliflozin 10 mg, linagliptin 5 mg or placebo. Participants in the empagliflozin group who did not reach HbA1c <7.0% by week 12 were re-randomised at week 14 to either remain on empagliflozin 10 mg or have their dose increased to 25 mg. Participants in the placebo group were randomised at week 26 to linagliptin 5 mg or one of the empagliflozin doses (10 mg or 25 mg).
Effects of Finerenone in Persons with CKD and T2D are Independent of HbA1c at Baseline, HbA1c Variability, Diabetes Duration and Insulin Use at Baseline
Diabetes Obes Metab. 2023; online ahead of print DOI: 10.1111/dom.14999
Given the role of HbA1c, diabetes duration and insulin use in determining morbidity and mortality of CKD in T2D, it is important to investigate whether these factors modify the efficacy and safety of therapies that mitigate the cardiorenal impact of CKD in T2D. This post hoc analysis of the FIDELITY database evaluated the effect of finerenone by baseline HbA1c, HbA1c variability, diabetes duration and baseline insulin use on cardiorenal outcomes and diabetes progression.
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Empagliflozin Cardiovascular and Renal Effectiveness and Safety Compared to Dipeptidyl Peptidase-4 Inhibitors across 11 Countries in Europe and Asia: Results from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) Study
Diabetes Metab. 2023; online ahead of print
Previously, the real-world EMPRISE US study found that empagliflozin initiation was associated with a lower risk of hospitalisation for HF, all-cause mortality and CV events when compared with DPP-4i.
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Efficacy of Dapagliflozin by Baseline Diabetes Medications: A Prespecified Analysis From the DAPA-CKD Study
Diabetes Care. 2023; online ahead of print DOI: 10.2337/dc22-1514
Achieving optimal glucose control can be challenging in patients with T2D and CKD because impaired kidney function hampers the use of several oral or injectable glucose-lowering therapies (GLTs) and increases the likelihood of hypoglycaemia. This prespecified analysis from the DAPA-CKD trial evaluated whether the benefits of dapagliflozin in patients with T2D and CKD varied by background GLT number or class.
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Effect of Finerenone on Ambulatory Blood Pressure in Chronic Kidney Disease in Type 2 Diabetes
J Hypertens. 2023;41:295–302 DOI: 10.1097/HJH.0000000000003330
It has been postulated that the effects of finerenone on cardiorenal outcomes may be mediated primarily via non-haemodynamic pathways, but office BP measurements are insufficient to fully assess haemodynamic effects. A substudy of the ARTS-DN phase IIb trial was conducted to obtain further insights into the mechanism of action of finerenone by analysing 24-h ambulatory BP in patients with CKD and T2D.
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Efficacy and Safety of Dapagliflozin by Baseline Insulin Regimen and Dose: Post Hoc Analyses From DECLARE-TIMI 58
Diabetes Care. 2022; online ahead of print DOI: 10.2337/dc22-1318
Limited data exist regarding the cardiorenal efficacy and safety of SGLT2i in patients treated with intensive insulin regimens including short-acting insulin or high insulin doses. This post hoc analysis of DECLARE-TIMI 58 examined the effects of dapagliflozin vs placebo among 7,013 insulin users at baseline, of whom 4,650 were on regimens that included short-acting insulin and 1,339 were receiving insulin >1 IU/kg.
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Efficacy and Safety of Dapagliflozin in Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction by Baseline Glycaemic Status (DELIVER): a Subgroup Analysis from an International, Multicentre, Double-blind, Randomised, Placebo-controlled Trial
Lancet Diabetes Endocrinol. 2022;10:869–881 DOI: 10.1016/S2213-8587(22)00308-4
Dapagliflozin was shown to be highly efficacious in patients with HFmrEF and HFpEF in the DELIVER trial. However, whether the benefits of dapagliflozin are observed across glycaemia categories has not been previously reported.
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Empagliflozin in Patients with Chronic Kidney Disease
N Engl J Med. 2022; online ahead of print
Among a wide range of at-risk patients with CKD, empagliflozin reduced progression of kidney disease or death from CV causes compared with placebo in the EMPA-KIDNEY trial.
Previous large trials involving patients with diabetic kidney disease and albuminuria have shown that SGLT2i reduce the risk of progression to kidney failure; however, most patients with CKD have low levels of albuminuria (UACR <300 mg/g) and do not have diabetes.
Finerenone efficacy in patients with chronic kidney disease, type 2 diabetes and atherosclerotic cardiovascular disease
Eur Heart J Cardiovasc Pharmacother. 2022; online ahead of print DOI: 10.1093/ehjcvp/pvac054
Finerenone reduced the risk of CV and kidney outcomes consistently across the spectrum of CKD in patients with T2D, irrespective of prevalent ASCVD.
Empagliflozin and Left Ventricular Remodeling in People Without Diabetes: Primary Results of the EMPA-HEART 2 CardioLink-7 Randomized Clinical Trial
Circulation. 2022; online ahead of print DOI: 10.1161/CIRCULATIONAHA.122.062769
Among patients with neither diabetes nor significant HF but with risk factors for adverse cardiac remodelling, empagliflozin did not result in a meaningful reduction in change in left ventricular mass indexed (LVMi) to baseline body surface area (BSA) after 6 months as measured by cardiac magnetic resonance imaging.
SGLT2i have demonstrated reverse cardiac remodelling in patients with diabetes or HF, but their effects earlier in the natural history of HF are less well studied.