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Vlado Perkovici, MBBS, PhD
The results of the CREDENCE study showed that canagliflozin (Invokana) reduced by 30% the risk of the composite primary endpoint, which included the course towards end-stage renal failure, defined by the need for kidney replacement therapy (chronic dialysis or kidney transplantation). ; doubling of serum creatinine; and renal or cardiovascular death.
The study evaluated the efficacy and safety of canagliflozin compared with placebo in patients with chronic renal failure (CKD) and type 2 diabetes (T2D), in more of the standard treatment.
"Canagliflozin is the first medical advance for nearly 20 years to slow the progression of chronic renal failure in diabetic patients at high risk of renal failure," said Vlado Perkovici, MBBS, PhD, co-chair of the executive committee of CREDENCE, executive director, George Institute for Global Health, Australia and professor of medicine, UNSW Sydney.
The CREDENCE study was completed in early July 2018 when researchers announced that predefined efficacy criteria had already been met. Perkovici called the results of this study "impressive" and added that these results have significant clinical implications for patients with chronic renal failure and type 2 diabetes.
The results of the CREDENCE study formed the basis of Janssen's additional drug demand (sNDA) for canagliflozin, which was submitted to the US Food and Drug Administration (FDA) in March 2019. The sNDA is seeking an indication to reduce the risk of terminal kidney disease, doubling serum creatinine and renal or cardiovascular death in adults with chronic kidney disease and T2DM. If approved, canagliflozin will be the first diabetes medicine available for patients with type 2 diabetes and chronic renal failure.
"We are working closely with the US FDA and health authorities around the world to bring this important drug to people with these life-threatening diseases," said James List, MD, PhD, who is responsible for the area. Global Therapeutics, Cardiovascular and Metabolism, Janssen Research & Development. , LLC.
The double-blind event study included 4401 patients with chronic stage 2 or 3 T2D nephropathy (estimated glomerular filtration rate between 30 and <90 mL / min / 1.73 m2) and macroalbuminuria (urinary albumin-creatinine ratio> 300 at ≤5,000 mg / g). All participants received standard care, including a maximum tolerated dose of ACE inhibitors or angiotensin II receptor blockers.
Canagliflozin decreased by 30% the risk of reaching the main compound endpoint (risk ratio [HR]0.70; 95% confidence interval [CI]0.59 to 0.82; P <0.0001) and reduced the risk of MSTP by 32% (HR: 0.68, 95% CI: 0.54 to 0.86; P = 0.0015).
In addition, canagliflozin reduced the risk of secondary endpoints by 31%, including the risk of cardiovascular death and hospitalization for heart failure (HR: 0.69, 95% CI: 0). 57 to 0.83; P = 0.0001), major adverse cardiovascular events (composite including nonfatal myocardial infarction, nonfatal stroke and CV death) of 20% (HR: 0.80, 95% CI: 0.67 to 0.95; P = 0.0121) and hospitalization risk for heart failure alone of 39% (HR: 0.61, 95% CI: 0.47 to 0.80; P = 0.0003).
Reports indicated that there were numerically fewer adverse events and serious adverse events in the canagliflozine group compared with placebo. There was no significant difference in the incidence of amputations (HR: 1.11, 95% CI: 0.79 to 1.56) or fractures badessed (HR: 0.98; 95% CI 0.70 to 1.37) between the 2 treatment groups.
The FDA first approved canagliflozin in 2013 as an addition to diet and exercise to support glycemic control in adults with T2D. In 2018, canagliflozin has also been approved for patients with type 2 diabetes and with established cardiovascular disease to reduce the risk of major adverse cardiovascular events, such as a heart attack, a stroke. brain or death.
Data from the CREDENCE study were presented today at the 2019 World Congress of the Society of Nephrology (ISN) in Melbourne, Australia, and published in The New England Medical Journal.
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