The results were consistent in patients both with and without type 2 diabetes (T2D). CKD is a serious, progressive condition defined by decreased kidney function affecting nearly 700 million people worldwide, many of them still undiagnosed, and the most common causes are diabetes, hypertension and glomerulonephritis.
The primary composite endpoint was ≥50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end stage kidney disease (ESKD) and CV or renal death. The absolute risk reduction (ARR) was 5.3% over the median time in study of 2.4 years. The trial also met all secondary endpoints, including significantly reducing death from any cause by 31% (ARR = 2.1%, p=0.0035) compared to placebo.
The co-chairs of the DAPA-CKD trial and its Executive Committee Prof. David Wheeler, University College London, UK and Prof. Hiddo L. Heerspink, University Medical Center Groningen, the Netherlands, said: “The impressive DAPA-CKD trial results are a remarkable development for patients with chronic kidney disease. These data have the potential to transform the standard of care for this patient population, which has a significant unmet need for new and improved treatment options.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “With today’s results, FARXIGA becomes the first SGLT2 inhibitor proven to significantly prolong the survival of patients with chronic kidney disease with and without type 2 diabetes and we look forward to sharing these data with regulatory authorities around the world. FARXIGA is also the first medicine in its class to demonstrate benefit in treating both heart failure and chronic kidney disease in patients with and without type 2 diabetes, and reduce the risk of hospitalization for heart failure and nephropathy in type 2 diabetes.”
The safety and tolerability of FARXIGA was consistent with the well-established safety profile of the medicine. In the trial, patients treated with FARXIGA experienced fewer serious adverse events compared to placebo (29.5% versus 33.9%, respectively). Diabetic ketoacidosis (DKA) was not reported in the FARXIGA group versus in two patients in the placebo group.
Detailed results from the DAPA-CKD trial were presented on Sunday, August 30 at the ESC Congress 2020 – The Digital Experience.
In May 2020, FARXIGA was approved in the US to reduce the risk of CV death and hospitalization for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D. FARXIGA is currently being assessed in patients with heart failure (HF) in the DELIVER (HF with preserved ejection fraction, HFpEF) and DETERMINE (HFrEF and HFpEF) trials, as well as in patients without T2D following an acute myocardial infarction (MI) or heart attack in the DAPA-MI trial – a first of its kind, indication-seeking registry-based randomized controlled trial.
In the US, FARXIGA is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D and to reduce the risk of hHF in adults with T2D and established CV disease or multiple CV risk factors. FARXIGA is not indicated to reduce the worsening of renal function or death in patients with CKD, or to reduce CV risk in patients with HFpEF or following an MI without T2D.
Source: Company Press Release