Diabetic kidney disease: canagliflozin cuts risk for renal failure, death

  • N Engl J Med
  • 14 Apr 2019

  • International Clinical Digest
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Takeaway

  • Canagliflozin (Invokana) yielded significant benefit in the phase 3 CREDENCE trial of patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD).

Why this matters

  • According to the manufacturer, findings were submitted to the FDA in March 2019 in a move to include CKD as an indication for canagliflozin in T2DM.

Study design

  • Interim analysis of data for 4401 patients with T2DM plus stage II or III CKD with albuminuria, randomly assigned to receive canagliflozin 100 mg/day or placebo alongside standard care with renin-angiotensin system blockade.
  • Median follow-up, 2.62 years.
  • Funding: Janssen Research and Development.

Key results

  • Canagliflozin yielded a 30% reduced risk for the composite primary endpoint of end-stage renal disease (ESRD), doubled serum creatinine, or renal/cardiovascular death (43.2 vs 61.2 events per 1000 patient-years; HR=0.70; P=.00001).
  • Renal outcomes: 34% reduced risk (HR=0.66; P<.001 driven by lower odds of serum creatinine doubling ci>
  • ESRD: 32% reduced risk (HR=0.68; P=.002); magnitude varied by definition:
    • Estimated glomerular filtration rate: HR=0.60 (95% CI, 0.45-0.80).
    • Dialysis initiation/renal transplant: HR=0.74 (95% CI, 0.55-1.00).
  • As in CANVAS, canagliflozin reduced risk for:
    • Cardiovascular death, myocardial infarction, or stroke (HR=0.80; P=.01).
    • Heart failure hospitalization (HR=0.61; P<.001>

Limitations

  • Early termination may have limited power for some secondary outcomes.

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