Canagliflozin safely reduced the risk of kidney failure and prevented cardiovascular events in patients with type 2 diabetes and chronic kidney disease, according to phase 3 results from the CREDENCE study presented at a late-breaking clinical trials session at the International Society of Nephrology’s World Congress of Nephrology Annual Meeting in Melbourne, Australia.
“We’re looking after an increasing number of patients with diabetes and chronic kidney disease,” David C. Wheeler, MD, FRCP, professor of kidney medicine at University College London, UK, said in a presentation. “According to data from the Global Burden of Disease Study, the number of deaths from this combination of type 2 diabetes and CKD doubled between 1990 and 2012. The outcomes for these patients are poor despite our current therapies.”
Researchers randomized 4,401 patients with type 2 diabetes and CKD to either placebo or 100 mg of canagliflozin (mean HbA1c, 8.3%; mean blood pressure, 140/78 mm Hg; 70% on statins). Primary endpoints of the study were the occurrence of ESKD, a doubling of serum creatinine, renal death or cardiovascular death with a median follow-up of 30 months.
Researchers found ESKD, doubling of serum creatine and renal or CV death occurred in 340 patients who took placebo and in 245 patients who took canagliflozin (HR= 0.70; 30% reduction with canagliflozin). Regarding renal-specific outcomes, a composite of ESKD, doubling of serum creatine or renal death occurred in 224 patients who took placebo and in 153 patients who took canagliflozin (HR = 0.66; 34% reduction with canagliflozin).
In addition, researchers observed a 32% risk reduction of ESKD in patients who took canagliflozin (HR = 0.68), as well as a 28% risk reduction for starting dialysis, having a kidney transplant or experiencing renal death.
Canagliflozin safely reduced the risk of kidney failure and prevented cardiovascular events in patients with type 2 diabetes and chronic kidney disease.
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Canagliflozin also attenuated the slope of chronic eGFR decline by 2.7 mL/min/1.73 m2 per year.
Finally, after evaluating safety outcomes, researchers concluded there was no difference in risk of fracture or lower extremity amputation in those who took placebo vs. canagliflozin.
“If we look at the effects of canagliflozin on the broad range of renal outcomes, we see clear and consistent benefits, regardless of how we define the renal events, which were highly statistically significant for the majority,” Vlado Perkovic, MBBS, PhD, FRACP, FASN, executive director of The George Institute and professor of medicine at the University of New South Wales in Sydney, said. – by Melissa J. Webb
Perkovic V and Wheeler DC. CREDENCE: Canagliflozin and renal events in diabetes with established nephropathy clinical evaluation. Presented at: ISN World Congress of Nephrology Annual Meeting. April 12-15, 2019; Melbourne, Australia.
Disclosures: Perkovic reports leading or serving on the steering committees of several trials and receiving honoraria for scientific presentations and/or advisory board attendance of Amgen, Eli Lily and Pfizer, among others. Wheeler reports consulting for Amgen, Bayer and Janssen, among others.