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Safety of dapagliflozin in a broad population of patients with type 2 diabetes – Analyses from the DECLARE – TIMI 58 study

Diabetes, Obesity and Metabolism Apr 08, 2020

Cahn A, Raz I, Bonaca M, et al. - Researchers conducted the study for comprehensively analyzing the safety of dapagliflozin in patients with type 2 diabetes (T2DM) with focusing on potential safety concerns related to the SGLT2‐inhibitors class. In DECLARE‐TIMI 58,17,160 individuals with T2DM were randomized to dapagliflozin or placebo and followed for a median of 4.2 years. Safety was assessed in 17,143 individuals receiving at least one dose of study drug. There was less incidence of acute kidney injury with dapagliflozin, and adverse effects indicative of volume depletion were balanced between treatment groups, regardless of baseline eGFR, blood pressure, diuretic or diuretic loop usage. Fractures and malignancies in the dapagliflozin vs placebo group were balanced regardless of gender, diabetes duration or smoking and fewer cases of bladder cancer occurred. There have been more adverse effects with genital infections that have resulted in the dapagliflozin vs placebo group discontinuation of the study drug, but there have been few serious genital infections and balanced between treatment groups. Urinary tract infections, acute pyelonephritis and urosepsis have also been balanced between treatment groups. The authors concluded that dapagliflozin was well tolerated. Long duration and large number of patient‐years in DECLARE‐TIMI 58 have been comprehensively addressed in previous safety issues, supporting dapagliflozin's robust safety profile.

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