The CREDENCE study data demonstrated that Invokana® (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 mellitus (T2DM).  The study met its primary endpoint showing that canagliflozin reduced the risk of composite 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, canagliflozin reduced the risk of the secondary renal endpoint composite of doubling of serum creatinine, ESKD, and renal death by 34%.  The study also showed that 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 hospitalization for heart failure by 31% and the risk of hospitalization for heart failure alone by 39% . With respect to safety data, the incidence rates of adverse events and serious adverse events were numerically lower for patients treated with canagliflozin compared with placebo. 

 

As the first dedicated clinical trial to investigate a SGLT2 inhibitor for renal protection in patients with T2DM with CKD, the data from CREDENCE provides the first significant update in nearly 20 years regarding slowing the progression of CKD for this group of patients. The trial, which was stopped early in July 2018 due to a signal of overwhelming efficacy in the prevention of the primary endpoint, was conducted in more than 4,400 adults with T2DM at 659 sites in 34 countries across North America, Latin America, Europe, South Africa and Asia Pacific.

 

In Europe, canagliflozin is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. 

 

“Canagliflozin is the first medical breakthrough in nearly 20 years proven to slow the progression of chronic kidney disease in patients with diabetes at high risk of developing kidney failure” said Professor Vlado Perkovic, Study Author and Executive Director of The George Institute, Australia, Professor of Medicine at UNSW Sydney. “These impressive results from the CREDENCE study have significant clinical implications for preventing kidney failure and improving health for millions of people living with chronic kidney disease and type 2 diabetes.”

 

Approximately 58 million people in Europe currently live with T2DM, which is set to rise to 67 million by 2045. If left untreated, patients are at greater risk of developing serious complications, such as CV disease and diabetic kidney disease (DKD). DKD is the leading cause for progression to ESKD, accounting for 50% of cases in the developed world. It is associated with a high risk of CV disease (heart attack, heart failure and stroke) and also amplifies the risk of other diabetes complications including; a reduced quality of life, infections, fatigue, depression, adverse drug reactions and premature death.

 

“With nearly 24 million type 2 diabetes patients in Europe likely to develop diabetic kidney disease, we are delighted with the results from the CREDENCE study which demonstrated superiority of canagliflozin, when added to the standard of care,” said Dr Vinicius Gomes de Lima, European Medical Affairs Lead, Mundipharma (the exclusive distributor of canagliflozin in the EU). “Type 2 diabetes is a growing epidemic in Europe and effective treatments are needed to help reduce the burden of the disease in patients. In particular, treatments are called for to improve renal outcomes which is of real importance in this disease.”