Excerpt

The cardiovascular (CV) safety of pharmacologic therapies to treat patients with type 2 diabetes mellitus (T2DM) has been a concern in the recent past [1‐4]. After a series of diabetes medications were observed to be potentially harmful, a guidance document heralded a change in regulatory requirements for any new antidiabetic agent seeking approval after 2008 [5]. Specifically, the guidance document [5] pragmatically identified patient populations at high CV risk that should be included in pre-marketing clinical trials, as they are likely to be treated with glucose-lowering agents (e.g., elderly patients, patients with renal impairment, those with advanced diabetes). Fortuitously, through larger studies aiming to prove CV safety, CV risk reduction has since been reported with two classes of antihyperglycemics—glucagon-like peptide-1 receptor agonist(s) (GLP-1 RA) [6] and sodium-glucose cotransporter-2 inhibitors (SGLT2i) [7, 8]. …