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Canagliflozin and renal outcomes in type 2 diabetes and nephropathy

New England Journal of Medicine Apr 18, 2019

Perkovic V, et al. - Researchers examining the efficacy of inhibitors of sodium–glucose cotransporter 2 (SGLT2) in improving renal outcomes in patients with type 2 diabetes. At a median follow-up of 2.62 years, patients with type 2 diabetes and kidney disease receiving canagliflozin displayed lower risk of kidney failure and cardiovascular events vs those receiving placebo.

Methods

  • Patients with type 2 diabetes and albuminuric chronic kidney disease were assigned to receive 100-mg canagliflozin daily or placebo.
  • Glomerular filtration rate (GFR) of 30 to < 90 mL/min/1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], > 300 to 5,000) were reported in all the patients who, thus, received treatment with renin–angiotensin system blockade.
  • A composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of < 15 mL/min/1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes was assessed as the primary outcome.
  • They tested the prespecified secondary outcomes hierarchically.

Results

  • Upon the recommendation of the data and safety monitoring committee, researchers stopped the trial early after a planned interim analysis.
  • At that time, 4,401 patients had been randomized, with a median follow-up of 2.62 years.
  • The canagliflozin group displayed 30% lower risk of the primary outcome than the placebo group, with event rates of 43.2 and 61.2 per 1,000 patient-years, respectively.
  • They also noted that the relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34%, and the relative risk of end-stage kidney disease was lower by 32%.
  • In addition, they observed a lower risk of cardiovascular death, myocardial infarction, or stroke, as well as hospitalization for heart failure in the canagliflozin group.
  • Rates of amputation or fracture were not significantly different between the groups.
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