AstraZeneca’s sodium-glucose cotransporter-2 (SGLT2) inhibitor Forxiga (ingredient: dapagliflozin) was effective to prevent kidney disease, the company said citing the DECLARE–TIMI 58 trial.
The company presented the sub-analyses of the data in the DECLARE-TIMI 58 cardiovascular study on Forxiga at the 79th Scientific Sessions of the American Diabetes Association in San Francisco, Calif., held from Friday to Tuesday.
|AstraZeneca’s sodium-glucose co-transporter-2 (SGLT2) inhibitor Forxiga|
The study was on 17,160 patients with type-2 diabetes, aiming to evaluate Forxiga’s effect on cardiovascular events. Forty-eight percent (8,162 patients) had the estimated glomerular filtration rate (EGFR) higher than 90mL/min/1.73m² and 45.1 percent (7,732) had the figure lower than 60mL/min/1.73m².
According to the analysis on cardiovascular-renal events such as 40 percent reduction or more in patients with less than eGFR 60 mL/min/ 1.73 m², development of end-stage kidney disease and death from renal or cardiovascular causes, Foxiga lowered the risk of such events by 24 percent compared to placebo.
In the sub-analysis, Forxiga reduced the risk of renal events, excluding death from a cardiovascular cause, by 47 percent, compared to placebo. The treatment also had a 46 percent reduction in a sustained decline in eGFR by at least 40 percent to less than 60 mL/min/1.73 m².
Six months after randomization, the mean decrease in eGFR was larger in the Forxiga-treated group than in the placebo group. The mean change equalized by two years and the mean decline in eGFR was less with dapagliflozin than with placebo at three and four years.
“We studied the effects of dapagliflozin in a broad population of patients with type 2 diabetes who are more representative of the overall diabetic population than previous trials, including a majority without established cardiovascular disease and with preserved renal function,” said co-principal investigator Itamar Raz, professor of internal medicine and director emeritus of the diabetes unit at Hadassah University Medical Center in Jerusalem, Israel.
These results emphasize the value of SGLT2 inhibitors as an important component of both the prevention and treatment of chronic kidney disease among patients with type 2 diabetes, he added.
AstraZeneca is also conducting Dapa-CKD trial to assess cardiovascular and renal effects of Forxiga in patients with chronic kidney disease, regardless of diabetes.
The results of the study will likely draw attention as it will evaluate not only preventive but therapeutic effects of the SGLT2 inhibitor as well.