Forxiga, the drug, showed a 47 per cent reduction in the composite of kidney function decline, end-stage renal disease or renal death in a pre-specified analysis from DECLARE-TIMI 58
AstraZeneca has announced that a pre-specified exploratory analysis of renal data from the Phase III DECLARE-TIMI 58 trial, the broadest cardiovascular outcomes trial of a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has shown that Forxiga (dapagliflozin) reduced the progression of kidney disease or renal death in patients with type-2 diabetes (T2D).
The data showed a 47 per cent reduction with Forxiga in the relative risk of the composite renal-specific outcome of kidney function decline (sustained ≥40 per cent decrease in estimated glomerular filtration rate [eGFR] to <60 mL/min/1.73m2), end-stage renal disease (ESRD), or renal death (excluding cardiovascular death) compared to placebo (1.5 per cent vs. 2.8 per cent; HR 0.53 [95 per cent CI 0.43-0.66]).
Additionally, Forxiga reduced the relative risk of a cardio-renal composite of kidney function decline, ESRD, or renal or cardiovascular (CV) death by 24 per cent compared to placebo (4.3 per cent vs. 5.6 per cent; HR 0.76 [95 per cent CI 0.67-0.87]).
This analysis evaluated 17,160 patients with T2D and predominantly preserved renal function, irrespective of underlying atherosclerotic CV disease (ASCVD).
People with diabetes have a six-to-twelve times higher risk of developing ESRD and are approximately twice as likely to develop chronic kidney disease (CKD) than those without.2,3
Elisabeth Björk, Senior Vice President, Head of Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, said, “Heart failure and renal diseases are two of the most common and early complications experienced by people living with type-2 diabetes, and are too often overlooked. They contribute to a growing economic burden on the global healthcare system and can lead to fatal outcomes for patients. These data continue to offer clinically relevant evidence of the early cardio-renal effects of Forxiga.”
These data were presented alongside other clinically important renal outcomes data from the DECLARE-TIMI 58 trial, including positive results from another sub-analysis that evaluated UACR, a key marker of kidney health. Forxiga improved renal function as measured by changes in UACR (improved from micro- to normo-albuminuria [HR 1.35, 95 per cent CI {1.24, 1.47}], improved from macro- to micro- or normo-albuminuria [HR 1.55, 95 per cent CI {1.34, 1.8}], and decreased deterioration from normo- to micro- or macro-albuminuria [HR 0.84, 95 per cent CI {0.79, 0.89}]).4
Forxiga is an inhibitor of SGLT2 indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D. Forxiga is not approved to reduce the risk of renal or CV death or to slow the progression of kidney disease.