1/11/2024 0 Comments Declare trial dapagliflozin![]() ![]() reports grants and personal fees from AstraZeneca and Novo Nordisk and personal fees from Abbott, Eli Lilly, Sanofi, Boehringer Ingelheim, Merck Sharp & Dohme, Medial Early-Sign, and GlucoMe. Long-term benefits can be expected in slowing of diabetes progression by maintenance of HbA 1c reduction and reducing microvascular complications as well as decreasing cardiovascular complications ( 17– 20).ĭuality of Interest. Our analyses of the large primary prevention population in the trial demonstrate a sustained benefit of dapagliflozin versus placebo added to standard of care in reducing HbA 1c, weight, and blood pressure. The unique mode of action of SGLT2 inhibitors, which is insulin independent, yields metabolic advantages in early as well as progressive T2D, when endogenous insulin reserves may have diminished. Multifactorial intervention targeting several cardiovascular risk factors, particularly when implemented in the early stages of T2D, is thus of paramount importance ( 16). T2D usually occurs in the constellation of the metabolic syndrome, with obesity, hypertension, and dyslipidemia being important comorbidities. In determination of the treatment regimen for patients with T2D, particularly in the case of lower risk patients without established ASCVD, several factors should be considered. Assessment of OutcomesĮGFR (CKD-EPI) (mL/min/1.73 m 2), mean (SD) The design, baseline characteristics, and principal results of this study have previously been published ( 6, 10, 12). The trial protocol was approved by the institutional review board at each participating site, and all participants provided written informed consent. All patients were treated according to guidelines and regional standards of care for cardiovascular risk factors, blood pressure, lipids, antithrombotic treatment, and HbA 1c. Patients with HbA 1c of 6.5 to <12.0% and creatinine clearance of ≥60 mL/min were eligible for inclusion. MRF participants were men aged ≥55 and women aged ≥60 years with at least one additional cardiovascular risk factor including dyslipidemia, hypertension, or current tobacco use. The trial included 6,974 patients with established ASCVD and 10,186 with MRF but without ASCVD. In DECLARE-TIMI 58, a total of 17,160 patients were randomly assigned to receive dapagliflozin 10 mg daily or placebo and followed for a median of 4.2 years. Still, all patients included in the studies of empagliflozin and ertugliflozin and most of the patients included in the canagliflozin program had established atherosclerotic cardiovascular disease (ASCVD), thus limiting our ability to extrapolate the effects of these drugs on populations without established ASCVD, which include the majority of patients with T2D ( 8, 9). Subsequently, published CVOTs demonstrated some heterogeneity with respect to SGLT2 inhibitor effects on MACE and cardiovascular death yet, the effects on HHF and renal outcomes were largely consistent ( 4– 7). The Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) trial, the first published cardiovascular outcome trial (CVOT) of a drug in the class, revolutionized our view of management of T2D by demonstrating significant reduction in risk for major adverse cardiovascular events (MACE) and cardiovascular death or hospitalization for heart failure (CVD/HHF), as well as significant reduction in the occurrence of adverse renal outcomes ( 2, 3). Early clinical trials with these agents demonstrated their capacity not only for lowering glucose but also for reducing weight and blood pressure, thus addressing several important components of the metabolic syndrome ( 1). Sodium–glucose cotransporter 2 (SGLT2) inhibitors have been approved for the treatment of type 2 diabetes (T2D) since 2012. ![]()
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