- 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.
- 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.
- 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>
- Early termination may have limited power for some secondary outcomes.