- Dapagliflozin slowed or prevented nephropathy progression in a diverse patient population with type 2 diabetes (T2D), whether they had established atherosclerotic cardiovascular disease (CVD) or not.
- Most participants in DECLARE-TIMI 58 trial had preserved renal function.
Why this matters
- This trial shows benefit in patients regardless of atherosclerotic CVD status.
- Median follow-up, 4.2 years (interquartile range, 3.9-4.4).
- Sustained decline in estimated glomerular filtration rate (eGFR) to 60 mL/minute/1.73 m2 was reduced by 46% with dapagliflozin vs placebo: HR 0.54 (95% CI, 0.43-0.67; P<.0001>
- Risk for end-stage renal disease/renal death also decreased with dapagliflozin: HR, 0.41 (95% CI, 0.20-0.82; P=.012).
- Previously reported: renal-specific composite outcome risk reduced by 47% in dapagliflozin vs placebo: HR, 0.53 (95% CI, 0.43-0.66; P<.0001>
- Authors report no significant interactions with most demographic, other measures.
- Analysis of data for 17,160 participants in DECLARE-TIMI 58 (10 mg dapagliflozin vs placebo once daily), which included patients with T2D, HbA1c 6.5%-12.0%, established atherosclerotic CVD (40.6%) or multiple risk factors, creatinine clearance ≥60 mL/minute.
- Follow-up: 4.2 years.
- Funding: AstraZeneca.
- The cardiorenal composite was a secondary outcome.
- For 1 of 2 primary outcomes (major adverse cardiovascular events), drug did not best placebo.