CANVAS Program - Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes

CANVAS Program - Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes

CANVAS Program integrated data from two trials involving a total of 10,142 participants with type 2 diabetes and high cardiovascular risk

• participants in each trial were randomly assigned to receive canagliflozin or placebo and were followed for a mean of 188.2 weeks
• primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke
• the CANVAS Program was a prespecified plan for the integrated analyses of the CANVAS and CANVAS-R trials (1,2)

Results:

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The study authors concluded:

• "...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..."

Key findings:

• CANVAS Program met its primary objective of demonstrating the cardiovascular safety and efficacy of canagliflozin
• canagliflozin use was associated with an increased risk of amputation which should be taken into consideration when prescribing this agent
• data suggest a favorable benefit/risk profile with canagliflozin treatment in many patients with type 2 diabetes and high cardiovascular risk

Reference:

• Neal B et al. Optimizing the analysis strategy for the CANVAS Program: A prespecified plan for the integrated analyses of the CANVAS and CANVAS-R trials.Diabetes Obes Metab. 2017 Jul;19(7):926-935
• Neal B et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes.N Engl J Med. 2017 Aug 17;377(7):644-657
• Neal B et al. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS) - a randomized placebo-controlled trial. Am Heart J 2013;166:217-223.e11
• Neal B et al. Rationale, design and baseline characteristics of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R): a randomized, placebo-controlled trial. Diabetes Obes Metab 2017;19:387-393