Title: Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes

Neal, B. et al.


What You Need to Know:

Results from the Canagliflozin Cardiovascular Assessment Study (CANVAS) Program found that, in type 2 diabetic patients at high risk of cardiovascular disease, treatment with canagliflozin resulted in a lower risk of cardiovascular events compared to placebo.

Trial Design:

  • CANVAS Program integrated data from two sister trials to evaluate the effect of canagliflozin on cardiovascular, renal, and safety outcomes
  • During the trials, a total of 10,142 type 2 diabetic patients with a high cardiovascular risk were monitored over an average of 188.2 weeks after being randomly assigned to receive canagliflozin or placebo
  • Primary endpoint: “composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke”

Key Outcomes:

  • Rate of primary outcome: 26.9 vs 31.5 patients per 1000-patient years for canagliflozin patients and placebo patients, respectively (HR: 0.86; 95% CI: 0.75, 0.97; P<0.001 for noninferiority; P=0.02 for superiority)
  • Based on prespecified hypothesis testing sequence, renal outcomes were not statistically significant
  • Canagliflozin possibly beneficial with respect to the progression of albuminuria (HR: 0.73; 95% CI: 0.67 to 0.79)
  • Canagliflozin possibly beneficial with respect to the “composite outcome of a sustained 40% reduction in the estimated glomerular filtration rate, the need for renal-replacement therapy, or death from renal causes” (HR: 0.60; 95% CI: 0.47, 0.77)
  • Adverse events observed were similar to previously reported risks of canagliflozin treatment, however an increased risk of amputation was seen (HR: 1.97; 95% CI: 1.41, 2.75)