By Colin Kenny, Editor – Diabetes Distilled
Dapagliflozin Effect on Cardiovascular Events–Thrombolysis in Myocardial Infarction 58 (DECLARE-TIMI 58) was a cardiovascular (CV) safety profile trial of dapagliflozin 10mg, a selective inhibitor of sodium–glucose cotransporter (SGLT2).Themulticentre, double-blind, randomised, placebo-controlled trial showed a significant 17% relative risk reduction in the co-primary endpoint of a composite of CV death or hospitalisation for heart failure (HF). This finding was driven by a 27% reduction in the rate of hospitalisation for HF in the dapagliflozin group, as there was no significant difference in CV death between the two study arms.
The DECLARE–TIMI 58 trial evaluated the effects of the SGLT2 inhibitor dapagliflozin on CV and renal outcomes in a broad population of patients who had or were at risk for atherosclerotic CV disease. Trial investigators recruited 17,160 patients who were aged 40 or older, had type 2 diabetes with an HbA1c level of >48 mmol/mol (>6.5%) but <108 mmol/mol (<12.0%), and a creatinine clearance of 60 ml per 1.73 m2 or more.
Dapagliflozin was non-inferior to placebo for the composite safety outcome of major adverse CV events (CV death, myocardial infarction or ischemic stroke), but it did not result in a significantly lower rate of events than placebo. The SGLT2 inhibitor did, however, lower the rate of the other prespecified primary efficacy outcome (the composite of CV death or hospitalisation for HF). Dapagliflozin lowered the rate of hospitalisation for HF in patients with type 2 diabetes at risk for atherosclerotic CV disease.
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