Diabetes frequently accompanies heart failure (HF) and HF is observed in up to 15% of patients with type 2 diabetes (T2D). The relationship between diabetes and the heart is, however, complex. It has long been known that diabetes is an important risk factor for coronary artery disease, resultant myocardial ischemia and infarctions leading to HF. But the direct effect of diabetes on the heart muscle is less clear.
The existence of a non-ischemic diabetic cardiomyopathy, disease of the cardiac muscle that is directly related to diabetes and not due to coronary atherosclerosis, has been a longstanding topic for debate. The recent EMPAREG-OUTCOME study in which patient assignment to the sodium-glucose co-transporter-2 (SGLT-2) inhibitor, empagliflozin, was associated with a reduction in HF hospitalizations by 35%1 (for unclear reasons) has reignited this discussion. Continue reading →
In the last 10 years, the study of medications for type 2 diabetes (T2D) has rapidly expanded its investigational footprint to evaluate cardiovascular (CV) effects, a shift driven largely by regulatory guidance that requires at least a demonstration of CV safety. Clinical investigators are also concerned with the effect diabetes medications have on atherosclerotic vascular outcomes as well as HF.
Working with Covance’s Dr. Jonathan Plehn in the webinar The Diabetic Heart: A Focus On Heart Failure, I recently provided a high-level overview of the clinical outcomes data examining the effect of antihyperglycemic therapies on heart failure (HF).
Only a handful of trials1 have analyzed more versus less-intensive glycemic control with regards to the effects on HF. In the ACCORD trial, there was a trend for increased risk with more intense glucose control (OR 1.23, 95% CI 0.97-1.57). In contrast, the UKPDS, ADVANCE and VADT trials suggested a favorable effect, although these results were not clinically relevant nor statistically significant. Meta-analysis of the totality of these data suggests there is essentially no effect, either positive or negative, on HF events with glycometabolic modulation using the older therapies available for T2D. Below, I review specific therapies in more detail. Continue reading →
Both type 2 diabetes (T2D) and heart failure (HF) are on the rise and reaching epidemic proportions. This is no surprise as the two conditions are physiologically related. Both are associated with an aging population, dietary indiscretions and sedentary lifestyles. However, debate continues about whether or not an essential diabetic cardiomyopathy exists or if the HF frequently observed in diabetics is due to common comorbid conditions such as coronary artery disease or hypertension. In any case, the epidemiology of the two conditions runs in parallel. HF is currently the most frequent hospital discharge diagnosis provided in US patients over the age of 65 and the prevalence of T2D is about 25% in this age group.
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Going Virtual: Evolving Real World Evidence Study Design for Speed, Flexibility and Lower Cost
Using a traditional clinical-site recruitment approach is no longer the only option in observational research. With the increased adoption of electronic informed consent methods by the FDA, it is now feasible to conduct real world evidence (RWE) studies using a virtual model that eliminates entirely the need for clinical sites.
Join us to learn how to lower cost and improve the efficacy of current, site-based RWE studies as well as:
The implications of electronic informed consent by the FDA
What is required to conduct a prospective virtual RWE study
How to use electronic data for a retrospective virtual RWE study