Cardiovascular Outcome Trials of Diabetes and Obesity Drugs: Implications for Conditional Approval and Early Phase Clinical Development

Over the past decade, clinical development and regulatory review of investigational drugs for diabetes and obesity have been guided by heightened standards for pre- and post-marketing assessment of cardiovascular safety. In high-risk patients with type 2 diabetes, several large multicentre cardiovascular outcome trials (CVOTs) have confirmed non-inferiority, i.e. cardiovascular safety for several glucose-lowering agents. More recent diabetes CVOTs have demonstrated major cardiovascular benefits for drugs representing two newer classes, sodium–glucose cotransporter (SGLT)-2 inhibition and glucagon-like peptide (GLP)-1 receptor agonists. Collectively, hard endpoint data from diabetes CVOTs have ushered in a new era of type 2 diabetes drug development and clinical care. Moreover, some unexpected cardiovascular side-effects have been unearthed for certain drugs.

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