Type 2 diabetes mellitus is associated with a substantial risk of cardiovascular and renal disease. (Funded by Janssen Research and Development CANVAS and CANVAS-R numbers, NCT01032629 and NCT01989754, respectively.) Introduction In two trials involving patients with type 2 diabetes and an elevated risk of cardiovascular disease, patients treated with canagliflozin had a lower risk of cardiovascular events than those who received placebo but a greater risk of amputation, primarily at the level of the toe or metatarsal. 3.4 participants per 1000 patient-years hazard ratio, 1.97 95% CI, 1.41 to 2.75) amputations were primarily at the level of the toe or metatarsal. Adverse reactions were consistent with the previously reported risks associated with canagliflozin except for an increased risk of amputation (6.3 vs. Although on the basis of the prespecified hypothesis testing sequence the renal outcomes are not viewed as statistically significant, the results showed a possible benefit of canagliflozin with respect to the progression of albuminuria (hazard ratio, 0.73 95% CI, 0.67 to 0.79) and 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 (hazard ratio, 0.60 95% CI, 0.47 to 0.77). 31.5 participants per 1000 patient-years hazard ratio, 0.86 95% confidence interval, 0.75 to 0.97 P<0.001 for noninferiority P=0.02 for superiority). The rate of the primary outcome was lower with canagliflozin than with placebo (occurring in 26.9 vs. The mean age of the participants was 63.3 years, 35.8% were women, the mean duration of diabetes was 13.5 years, and 65.6% had a history of cardiovascular disease.
The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.
Participants in each trial were randomly assigned to receive canagliflozin or placebo and were followed for a mean of 188.2 weeks. The CANVAS Program integrated data from two trials involving a total of 10,142 participants with type 2 diabetes and high cardiovascular risk. We report the effects of treatment with canagliflozin on cardiovascular, renal, and safety outcomes. The most trusted, influential source of new medical knowledge and clinical best practices in the world.Ĭanagliflozin is a sodium–glucose cotransporter 2 inhibitor that reduces glycemia as well as blood pressure, body weight, and albuminuria in people with diabetes.
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