FDA Approves Farxiga (dapagliflozin) to Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes

21 October 2019 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) to reduce the risk of hospitalization for heart failure (hHF) in adults with type 2 diabetes (T2D) and established...
Source: Drugs.com - New Drug Approvals - Category: Drugs & Pharmacology Source Type: news

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Type 2 diabetes mellitus (T2DM) represents a major health problem,1 contributing to 11.3% of deaths globally.2 Cardiovascular disease (CVD) still affects a large proportion of patients,3 despite the fact that incidence rates of cardiovascular outcomes have decreased over the last two decades.4 Heart failure (HF) is a main contributor of cardiovascular morbidity and mortality among patients with T2DM,5 who feature an almost twofold increase in the risk of HF, with women having a greater risk compared to men.
Source: The American Journal of Cardiology - Category: Cardiology Authors: Source Type: research
Authors: Nguyen C, Luthra R, Kuti E, Willey VJ Abstract Background: Description of risk of cardiovascular (CV) events associated with diabetes is evolving. This US-based real-world study estimated risk of future CV events and heart failure (HF) from type 2 diabetes (T2DM)-only, prior CV events-only, or T2DM + prior CV events, versus controls, and evaluated healthcare resource utilization (HCRU) and costs.Methods and Materials: This retrospective cohort study queried claims and mortality data for 638,301 patients: T2DM-only (377,205); prior CV events-only (130,964); both T2DM + prior CV e...
Source: Current Medical Research and Opinion - Category: Research Tags: Curr Med Res Opin Source Type: research
AbstractPurpose of ReviewThis narrative review makes the case for greater efforts to reduce cardiovascular disease (CVD) risk in women with diabetes.Recent FindingsIn a recent meta-analysis including five CVOTs of diabetes medications with 46,606 subjects, women (vs men) with type 2 diabetes had a higher relative risk for stroke (RR 1.28; 95% CI 1.09, 1.50) and heart failure (1.30; 1.21, 1.40). Prior studies found higher “within-gender” RR for CVD mortality in women with diabetes although men have an absolute higher risk. Women with prior gestational diabetes mellitus (GDM) have a 2-fold higher CVD risk than th...
Source: Current Diabetes Reports - Category: Endocrinology Source Type: research
Abstract Background: In patients with type 2 diabetes mellitus (T2DM), sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure (HHF). We assessed the effect of ertugliflozin on HHF and related outcomes. Methods: VERTIS CV, a double-blind, placebo-controlled trial, randomized patients with T2DM and atherosclerotic cardiovascular (CV) disease to once-daily ertugliflozin 5 mg, 15 mg or placebo. Prespecified secondary analyses compared ertugliflozin (pooled doses) versus placebo on time to first event of HHF and composite of HHF/CV death, overall and stratified by prespec...
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research
It is well known that individuals with type 2 diabetes (T2D) have a higher incidence of heart failure than those without.(1) Less is known, however, about the relationship between impaired glucose tolerance (IGT) and heart failure incidence, and whether treating IGT to delay or prevent development of T2D might reduce the incidence of heart failure. China has one of the highest rates of IGT and new-onset T2D in the world.(2) In addition, the China Heart Survey showed that the prevalence of IGT is significantly higher in individuals with coronary heart disease (CHD), compared with those without CHD.(3) Thus, the combination ...
Source: Diabetes Research and Clinical Practice - Category: Endocrinology Authors: Source Type: research
Adults with obesity and type 2 diabetes mellitus (T2DM) related to obesity are at increased risk of heart failure with preserved ejection fraction (HFpEF). Whether left ventricular (LV) diastolic function abno...
Source: Cardiovascular Diabetology - Category: Cardiology Authors: Tags: Original investigation Source Type: research
AbstractBackgroundSeveral clinical trials of dapagliflozin in patients with type 2 diabetes mellitus (T2DM) at elevated cardiovascular risk have observed reduced hospitalization for heart failure (HHF). Several studies have also suggested cardiovascular benefits for patients with HF regardless of whether or not they have T2DM.ObjectiveThis meta-analysis was conducted to evaluate the therapeutic effects of dapagliflozin in patients with HF.MethodsThe PubMed, Embase, Cochrane Library, and Web of Science databases were systematically searched from database inception to 15 February 2020. Clinical studies of dapagliflozin use i...
Source: American Journal of Cardiovascular Drugs - Category: Cardiology Source Type: research
Cardiorespiratory fitness (CRF) is an important prognostic indicator of morbidity and mortality in patients with heart failure (HF), especially in those with comorbid type 2 diabetes mellitus (T2DM). Bioelectrical impedance analysis (BIA) is an objective and reproducible method to estimate the edema index (EI), a surrogate for extracellular volume status. Whether an increase in the EI estimated by BIA can identify patients with reduced CRF is unknown. We hypothesized that in patients with HF and reduced ejection fraction (HFrEF) and T2DM, an increased EI would inversely correlate with measures of CRF.
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Tags: 130 Source Type: research
Heart failure with preserved ejection fraction (HFpEF) is an increasingly prevalent disease which is strongly associated with cardiometabolic disease (CMD). Type 2 diabetes (DM2) is associated with worse outcomes in this patient population; however, it is not clear if the addition of other cardiometabolic risk factors further increases this risk.
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Tags: 339 Source Type: research
Authors: Orime K, Terauchi Y Abstract INTRODUCTION: Saxagliptin, a member of the dipeptidyl peptidase-4 inhibitor (DPP-4i) class of drugs, was approved by the FDA for the treatment of type 2 diabetes (T2D) in 2009, and has been in clinical use for more than a decade. Since the drug was first launched, much real-world evidence has also been accumulated. The efficacy and safety of saxagliptin, especially its cardiovascular safety, are of particular interest. AREAS COVERED: This review provides an overview of the safety and efficacy of saxagliptin based on observational studies, pharmacovigilance, and meta-analyse...
Source: Expert Opinion on Pharmacotherapy - Category: Drugs & Pharmacology Tags: Expert Opin Pharmacother Source Type: research
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