Napp has today welcomed the CREDENCE (Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation) study data which successfully demonstrated that canagliflozin reduces the risk of renal and cardiovascular (CV) events and has an acceptable safety profile consistent with previous studies when added to standard of care in subjects with type 2 diabetes.
The study met its primary endpoint showing that canagliflozin reduced the risk of composite of doubling of serum creatinine, end-stage kidney disease (ESKD) and renal or CV death by 30%. These findings were consistent across the individual components of the primary composite endpoint, as well as across all 15 subgroups tested.
In addition, the CREDENCE trial achieved several further secondary endpoints which include:
- canagliflozin reduced the risk of the secondary renal endpoint composite of doubling of serum creatinine, ESKD, and renal death by 34%
- canagliflozin reduced the risk of major adverse cardiac events (MACE) (composite of non-fatal myocardial infarction, non-fatal stroke and CV death) by 20%
- the risk of CV death and hospitalisation for heart failure by 31%
- the risk of hospitalisation for heart failure alone by 39%.
In regard to safety data, the incidence rates of adverse events and serious adverse events were numerically lower for patients treated with canagliflozin as compared to placebo.
There were no observed differences in the incidence of lower limb amputations or adjudicated fractures.
The data from CREDENCE provides an important update regarding slowing the progression of chronic kidney disease for this group of people with type 2 diabetes. The trial, which was stopped early in July 2018 due to a conclusive signal of efficacy in the prevention of the primary endpoint, was conducted in more than 4400 adults with type 2 diabetes at 659 sites worldwide, including 37 locations across the UK.
David Wheeler, Professor of Kidney Medicine at University College London, UK and Honorary Consultant Nephrologist at the Royal Free NHS Foundation Trust, University College London, said: “Kidney disease develops in approximately 40% of people with type 2 diabetes. We have been waiting for new drugs to help us manage these patients for almost 20 years. The exciting results from the CREDENCE study provide renewed optimism for these patients.”
Andrea Brown, spokesperson for the National Kidney Federation, said: “The exciting research from CREDENCE is the first positive dedicated trial of an antidiabetic agent in this area, showing how under-recognised the irreversible impact of chronic kidney disease and type 2 diabetes has been up until now.”
Hywel Day, Managing Director, Napp Pharmaceuticals Ltd, said: “We are extremely proud to support developments like this, that ultimately help to move medicine forward.”