Heart-smart approaches to diabetes management – QI&CPD – Category 2

Most clinical development programs for diabetes drugs have historically focussed on their glucose-lowering ability with limited cardiovascular safety assessments. This was based on the proven correlation between glycaemic control and microvascular complications on the one hand, with inconclusive data regarding cardiovascular benefits on the other. In some instances, intensive glycaemic control may actually promote negative cardiovascular effects despite improvement of hyperglycaemia. Additionally, in 2008, the thiazolidinedione rosiglitazone was temporarily removed from the US market because of its potential negative impact on cardiovascular disease (CVD) outcomes. Several health authorities subsequently issued a requirement for the assessment of CVD risk for all new diabetes drugs, and several cardiovascular outcome studies have resulted as a consequence. In 2015, the Food and Drug Administration (FDA) removed prescribing and dispensing restrictions on rosiglitazone medicines in light of new data that showed no increasedrisk of heart attack with these drugs compared to metformin and SUs.