Randomized Trials to Evaluate Cardiovascular Safety of Antihyperglycemic Medications

Randomized Trials to Evaluate Cardiovascular Safety of Antihyperglycemic Medications: A Worthwhile Effort?

Philippe Gabriel Steg, MD Ronan Roussel, MD, PhD Glucose control is a key aspect of diabetes management. After concerns about the cardiovascular safety of several classes of antihyperglycemic agents, culminating with concerns about thiazolidinediones, the US Food and Drug Administration implemented a guidance statement in 2008 (strongly) recommending the demonstration of cardiovascular safety o...

Antihyperglycemic Medications and Cardiovascular Risk Reduction

Testing cardiovascular drug safety and efficacy in randomized trials.

Randomized trials provide the gold standard evidence on which rests the decision to approve novel therapeutics for clinical use. They are large and expensive and provide average but unbiased estimates of efficacy and risk. Concern has been expressed about how unrepresentative populations and conditions that pertain in randomized trials might be of the real world, including concerns about the ho...

A review of the efficacy and safety of several antihyperglycemic medications in the management of cardiovascular disease in diabetes

Diabetes is a worldwide public health problem affecting millions of people. By 2030, the incidence of diabetes is expected to increase to 4.4% of the global population, an equivalent of approximately 366 million people. This growth of the “diabetes pandemic” is even more pronounced in certain countries including the United States, which is expected to have a 165% increase in prevalence by 2050 ...

Randomized Trials in Cardiovascular Imaging

A decade ago, cardiovascular imaging was buffeted by a perfect storm of disproportionate growth, unexplained geographic variability, skyrocketing costs, inadequate evidence base, and competition among specialties and modalities. Fortunately, the imaging community and, more broadly, the house of cardiology have appropriately responded to the crisis by fully embracing the concept of value over vo...