Dapagliflozin Gets Breakthrough Therapy Status for CKD Indication
The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
The 2020 ADA guideline update reflects evidence from recent major trials with cardiovascular and renal outcomes.
Dapagliflozin appears to preserve kidney function and improve survival in patients with chronic kidney disease whether or not they have type 2 diabetes.
In a trial, empagliflozin reduced the risks for heart failure hospitalization and renal outcomes in patients with heart failure with reduced ejection fraction.
The FDA concluded “the risk no longer meets the standard for a Boxed Warning.”
The multicenter, event-driven, double-blind, placebo-controlled trial compared the effect of dapagliflozin to placebo on renal outcomes and cardiovascular mortality in patients with CKD.
Onset at younger age with longer diabetes duration may add to risk for end-stage kidney disease.
Median prevalence of any underlying medical condition is 47.2% for residents in all 50 states, DC.
SARS-CoV-2, the virus that causes COVID-19, enters cells by binding to ACE2 on cell surfaces. Investigators performed a comparative analysis of specimens of diabetic kidney disease tissue and healthy tissue for ACE2 expression.
Early results from the phase 3 FIDELIO-DKD study also show that finerenone reduces the risk for a cardiovascular secondary endpoint in patients with diabetic kidney disease.