Diabetes Breakthrough: AstraZeneca’s Farxiga (Dapagliflozin) Significantly Reduces Risk of Rapid Kidney Function Decline in Broad Patient Population

June 16, 2020 News /BioValleyBIOON/ --AstraZeneca(AstraZeneca) recently in the United StatesDiabetesAmerican Diabetes Association (ADA) 80th Scientific SessionsMeetingNew subgroup analysis of the landmark cardiovascular outcomes trial (CVOT) DECLARE-TIMI 58 for the SGLT2 inhibitor Farxiga (Chinese brand name: Andatang; generic name: dapagliflozin) was published.

The results showed that in type 2 diabetes patients with cardiovascular disease or at high risk for cardiovascular disease,DiabetesAmong patients, Farxiga reduced the risk of rapid decline in estimated glomerular filtration rate (eGFR) (fast decline, FD) compared with placebo, demonstrating consistent effects across all subgroups regardless of baseline characteristics.

eGFR is a commonly used indicator for assessing renal function. This analysis confirms:Compared with placebo, Farxiga can reduce the risk of rapid eGFR decline (FD) in a broad patient population.

SGLT2 inhibitors may cause a short-term decline in eGFR, followed by stabilization and a long-term reduction in the risk of end-stage renal disease. A rapid decline in eGFR (FD) can be defined as ≥3 mL/min/1.73 m² per year. In this post hoc analysis, researchers evaluated the effect of Farxiga on the risk of rapid eGFR decline (FD) in the DECLARE-TIMI 58 trial.

In the DECLARE-TIMI 58 trial, a total of 17,160 patients with type 2 diabetes and either established cardiovascular disease or high risk for cardiovascular disease were enrolled.Diabetes(T2D) patients had a mean baseline eGFR of 85.2 ml/min/1.73 m² and were randomized to the Farxiga group or the placebo group, with a median follow-up of 4.2 years.

This analysis compared the risk of FD between two treatment groups. Over the time frame from 0.5 years (post-stabilization) to 4 years, the proportion of patients with FD was lower in the Farxiga group than in the placebo group (26.8% vs. 37.1%, p < 0.0001). This result was consistent across all evaluated subgroups.

The mean (SD) annual eGFR decline rates for patients with FD (n=4788) and those without FD (n=10224) were 6.3 (3.7) and 0.0 (2.5) mL/min/1.73 m²/year, respectively.

Throughout the study period (0–4 years), the proportion of patients with FD was lower in the Farxiga group than in the placebo group (33.6% vs. 37.0%, p < 0.0001).

The above results confirm that: in a broad population of patients with type 2 diabetes accompanied by cardiovascular disease or at high risk for cardiovascular disease,DiabetesAmong patients, Farxiga reduced the risk of rapid eGFR decline (FD) compared with placebo, thereby preserving renal function to a relative extent, and this benefit was independent of patients’ baseline characteristics. (Bioon.com)

Original Source: New sub-analysis from the DECLARE-TIMI 58 trial, presented orally, providing insights on Farxiga’s effect on fast kidney function decline in T2D patients with established or increased risk for cardiovascular disease (Abstract #303-OR)