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Showing 39 results for “Safety”.

March 2023

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).

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February 2023

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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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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December 2022

Empagliflozin in Black Versus White Patients with Heart Failure: Analysis of EMPEROR-Pooled

Circulation. 2022; online ahead of print DOI: 10.1161/CIRCULATIONAHA.122.062644

While analyses from DAPA-HF and EMPEROR-Reduced demonstrated a consistent benefit of SGLT2i in Black patients, data were limited to HFrEF and included a small number of Black patients. In the current analysis, the efficacy and safety of empagliflozin according to Black vs White race in the Americas was assessed across the spectrum of EF in EMPEROR-Pooled, a combined dataset from both EMPEROR trials.

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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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Effects of Empagliflozin on Cardiovascular and Renal Outcomes in Heart Failure with Reduced Ejection Fraction According to Age: a Secondary Analysis of EMPEROR-Reduced

Eur J Heart Fail. 2022; online ahead of print DOI: 10.1002/ejhf.2707

Results from EMPEROR-Reduced demonstrated that empagliflozin improved CV and renal outcomes in patients with HFrEF, but its efficacy and safety across patient's age is not well established.

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January 2023

Empagliflozin, Irrespective of Blood Pressure, Improves Outcomes in Heart Failure with Preserved Ejection Fraction: the EMPEROR-Preserved Trial

Eur Heart J. 2022; online ahead of print DOI: 10.1093/eurheartj/ehac693

Results from EMPEROR-Preserved demonstrated that empagliflozin improved CV and renal outcomes in patients with HFpEF, but its efficacy and safety with baseline SBP is not well established.

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October 2022

Network meta-analysis of mineralocorticoid receptor antagonists for diabetic kidney disease

Front Pharmacol. 2022;13:967317 DOI: 10.3389/fphar.2022.967317

A network meta-analysis has found that newer mineralocorticoid receptor antagonists (MRAs) appear to have greater efficacy in reducing urine albumin creatinine ratio (UACR) vs baseline than traditional MRAs in the treatment of diabetic kidney disease (DKD).

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