This is a summary of the European public assessment report (EPAR) for Velmetia. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Velmetia
Diabetes News
Category: Medication
Obesity as a modifier of the Cardiovascular effectiveness of Sodium-Glucose Cotransporter-2 Inhibitors in Type 2 Diabetes
Compared with DPP-4i, the cardioprotective effect associated with SGLT2i is stronger among patients with higher BMI (Diabetes Research and Clinical Practice)
Dapagliflozin and Prevention of Kidney Disease Among Patients With Type 2 Diabetes: Post Hoc Analyses From the DECLARE-TIMI 58 Trial
Dapagliflozin mitigated kidney function decline in patients with T2D at high cardiovascular risk, including those with low KDIGO risk, suggesting a role of dapagliflozin in the early prevention of diabetic kidney disease (Diabetes Care)
Effects of tirzepatide versus insulin glargine on kidney outcomes in type 2 diabetes in the SURPASS-4 trial: post-hoc analysis of an open-label, randomised, phase 3 trial
Our analysis suggests that in people with type 2 diabetes and high cardiovascular risk, tirzepatide slowed the rate of eGFR decline and reduced UACR in clinically meaningful ways compared with insulin glargine (The Lancet Diabetes & Endocrinology)
Glycemia Reduction in Type 2 Diabetes — Microvascular and Cardiovascular Outcomes
We assessed the comparative effectiveness of four commonly used glucose-lowering medications, added to metformin, in achieving and maintaining a glycated hemoglobin level of less than 7.0% in participants with type 2 diabetes (NEJM)
Real-World Treatment Patterns of Glucose-Lowering Agents Among Patients with Type 2 Diabetes Mellitus and Cardiovascular Disease or At Risk for Cardiovascular Disease
Although use of SGLT-2is and GLP-1 RAs increased over time, overall utilization of these agents in patients with T2D and ASCVD/HF or at risk for ASCVD/HF remained low, especially for those aged ≥ 65 years (Diabetes Therapy)
Mechanisms underlying the blood pressure lowering effects of empagliflozin, losartan and their combination in people with type 2 diabetes: a secondary analysis of a randomized cross-over trial
In people with T2D, SGLT2 inhibition in combination with ARB had a larger blood-pressure lowering effect versus placebo than either of the drugs alone. Our data further suggest that the mechanisms underlying these blood pressure reductions at least partially differ between these agents (Diabetes, Obesity and Metabolism)
Sodium-Glucose Cotransporter 2 Inhibitors and Risk of Hyperkalemia in People With Type 2 Diabetes: A Meta-Analysis of Individual Participant Data From Randomized, Controlled Trials
SGLT2 inhibitors reduce the risk of serious hyperkalemia in people with type 2 diabetes at high cardiovascular risk or with chronic kidney disease without increasing the risk of hypokalemia (Circulation)
Association Between SGLT2 Inhibitor Treatment and Diabetic Ketoacidosis and Mortality in People With Type 2 Diabetes Admitted to Hospital With COVID-19
We demonstrate a low risk of DKA and high mortality rate in people with T2D admitted to hospital with COVID-19 and limited power, but no evidence, of increased risk of DKA or in-hospital mortality associated with prescription of SGLT2is (Diabetes Care)
Open-Source Automated Insulin Delivery in Type 1 Diabetes
In children and adults with type 1 diabetes, the use of an open-source AID system resulted in a significantly higher percentage of time in the target glucose range than the use of a sensor-augmented insulin pump at 24 weeks (NEJM)
Dapagliflozin improves myocardial flow reserve in patients with type 2 diabetes: the DAPAHEART Trial: a preliminary report
SGLT-2 inhibition increases MFR in T2D patients. We provide new insight into SGLT-2i CV benefits, as our data show that patients on SGLT-2i are more resistant to the detrimental effects of obstructive coronary atherosclerosis due to increased MFR, probably caused by an improvement in coronary microvascular dysfunction (Cardiovascular Diabetology)
Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study
In people with type 1 diabetes using multiple daily injections of insulin plus isCGM and with HbA1c of at least 8%, the use of AHCL confers benefits in terms of glycaemic control beyond those that can be achieved with multiple daily injections of insulin plus isCGM. These data support wider access to AHCL in people with type 1 diabetes not at target glucose levels (The Lancet Diabetes & Endocrinology)
Sodium–Glucose Cotransporter 2 Inhibitors in Cardiovascular and Renal Outcomes in Patients With Diabetes but Without Established Cardiovascular Disease: A Nationwide Population-Based Cohort Study
Our study provided clinical evidence that the cardiovascular and renoprotective benefits of SGLT2 inhibitors could be consistently extended to primary prevention strategies among patients with diabetes with low cardiovascular risk (Diabetes Care)
Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction
Dapagliflozin reduced the combined risk of worsening heart failure or cardiovascular death among patients with heart failure and a mildly reduced or preserved ejection fraction (NEJM)
PATAS, a First-in-Class Therapeutic Peptide Biologic, Improves Whole-Body Insulin Resistance and Associated Comorbidities In Vivo
PATAS represents a novel first-in-class peptide that targets the adipocyte to ameliorate insulin resistance and its associated comorbidities (Diabetes)
Transitioning to active-controlled trials to evaluate cardiovascular safety and efficacy of medications for type 2 diabetes
In summary, the rapidly evolving therapeutic environment for T2DM has provided new options for patients that can further mitigate risk for CV disease complications, which remains a major cause of mortality and morbidity in this population (Cardiovascular Diabetology)
New insights into the role of empagliflozin on diabetic renal tubular lipid accumulation
EMPA inhibited the AGEs-RAGE pathway, thereby alleviating diabetic renal tubular cholesterol accumulation (Diabetology & Metabolic Syndrome)
Association of Time in Range with Endothelial Injury in Patients with Type 2 Diabetes Treated with Exenatide
Treatment with exenatide increases TIR and decreases glycemic variability in patients with T2DM. Moreover, the amelioration of endothelial injury is more pronounced in patients with TIR > 70% after the treatment (Diabetes Therapy)
Contemporary use of SGLT2 inhibitors in heart failure patients with diabetes mellitus: a comparison of DPP4 inhibitors in a nationwide electric health database of the superaged society
The use of SGLT2 inhibitors at discharge was associated with a lower risk of one-year mortality and HF readmission in patients across a broad spectrum of HF with DM in the superaged society. The findings further support the benefits of using SGLT2 inhibitors in very elderly HF care and complement the current evidence (Cardiovascular Diabetology)
SGLT2 inhibitors in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials balancing their risks and benefits
Our study is limited to aggregate data. In a population of individuals with type 2 diabetes and a high CVD risk, the cardiovascular and renal benefits of SGLT2i remain substantial despite the risk of DKA and even the hypothetical risk of amputation (Diabetologia)
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