8. Drug Update

Dapagliflozin receives positive results in Phase III DECLARE-TIMI 58 cardiovascular outcomes trial

Preliminary results of the largest, longest, and broadest cardiovascular outcomes trial (CVOT) to date with a T2DM drug, DECLARE – TIMI, have been announced. DECLARE – TIMI 58 is a superiority trial conducted in over a period of up to 5 years across 33 countries and in more than 17,000 T2DM adults to test whether long-term treatment with Dapagliflozin, an oral sodium glucose cotransporter 2 (SGLT2) inhibitor, can lower the incidence of cardiovascular death, myocardial infarction, or ischemic stroke and/or the incidence of cardiovascular death or hospitalization for heart failure. The trial revealed that dapagliflozin met its primary safety endpoint of noninferiority for major adverse cardiovascular events (MACE) and achieved a significant reduction in the composite endpoint of hospitalization for heart failure or CV death.

The SGLT2 inhibitors are perceived as the game-changers in T2DM therapy due to the landmark results of EMPA-REG and CANVAS trials. Although dapagliflozin was one of the first SGLT2 inhibitors on the market, launched in the United States in 2014 a year after canagliflozin was approved, the CVOT for dapagliflozin was the longest and largest, and hence took longer to complete.

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