Advances in the management of cardiovascular risk for patients with type 2 diabetes: perspectives from the Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes

Abstract

Diabetes is a global health emergency projected to affect 642 million people by 2040. Type 2 diabetes (T2D) represents 90% of diabetes cases and is associated with a range of cardiovascular (CV) risk factors that are more than double the incidence of CV disease and significantly increase mortality rates. Diabetes treatments have typically focused on improving glycemic control but their effect on CV outcomes has remained uncertain. In 2008, the US Food and Drug Administration (FDA) looked to address this knowledge gap and mandated CV outcome trials (CVOTs) for all new antidiabetic therapies. In 2015, EMPA-REG OUTCOME® became the first CVOT to present results for a sodium/glucose cotransporter 2 (SGLT2; also known as SLC5A2) inhibitor, empagliflozin. Subsequently, a regional meeting of the Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes (ACROSS T2D) brought together a respected faculty of international experts and 150 physicians from 14 countries to discuss the current unmet medical needs of patients with T2D, the results from the EMPA-REG OUTCOME study and the implications of these results for clinical practice. This article summarizes the current scientific evidence and the discussions that took place at the ACROSS T2D regional meeting, which was held in Vienna, Austria, on May 30, 2016.

Benefits and Harms in Pivotal Trials of Oral Centrally Acting Antiobesity Medicines: A Systematic Review and Meta‐Analysis

“…Pivotal trials examining the effects of targeted therapy could be explored, seeking patients in whom the benefits outweigh the harms, such as those with low risks of cardiovascular or neuropsychiatric events who are struggling to lose weight (through lifestyle and/or behavioral interventions) but do not meet the criteria for surgical intervention. Postmarketing trials, specifically those designed to explore the risks of cardiovascular and neuropsychiatric events associated with the products, should also be considered; for example, the cardiovascular outcomes trials have been used to investigate the risk of cardiovascular disease in patients taking antidiabetic therapy . In developing new and effective antiobesity medicinal products, mechanisms other than actions on central neurotransmitters could also be targeted, such as leptin, glucagon‐like peptide 1 (GLP‐1) receptor agonists, islet amyloid polypeptide (IAPP), and neuropeptide Y .…”

Serum C‐reactive protein in the prediction of cardiovascular diseases: Overview of the latest clinical studies and public health practice

“…One of the other remarkable features of hs-CRP (especially in high levels) is its strong and independent correlation with type II diabetes (Asemi, Zare, Shakeri, Sabihi, & Esmaillzadeh, 2013;Schernthaner et al, 2017). Increased levels of hs-CRP are a significant predictor for the future diagnosis of metabolic syndrome and type II diabetes and remain effective even after considering smoking, family history of diabetes mellitus, BMI, and other factors (Gurven et al, 2016;Martín-Timón, Sevillano-Collantes, Segura-Galindo, & del Cañizo-Gómez, 2014).…”

Relevance of positive cardiovascular outcome trial results in clinical practice: perspectives from the Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes (ACROSS T2D)

“…The safety data in EMPA-REG OUTCOME also demonstrate that, conceptually, it may not be necessary to understand the intricacies of the MoA of empagliflozin – as yet not fully understood – given that there is now reassurance from safety data, combined with proven efficacy. 3 , 20 After all, metformin was, and is, still prescribed almost universally without such an understanding.…”

“…The life expectancy of a 60-year-old male patient with T2D and CVD is reduced by 12 years compared with the general population. 1 – 3 There are multiple therapeutic agents now available or in the pipeline for the treatment of T2D ( Figure 1 ), and establishing their cardiovascular (CV) safety has become a key factor in the approval process, with cardiovascular outcomes trials (CVOTs) now being mandatory for all new agents.…”