Canvas/Canvas-R presented at ADA

The much awaited combined results from the Canagliflozin Cardiovascular Assessment Study (CANVAS) and the CANVAS renal-end-points trial (CANVAS-R) were presented at the American Diabetes Association (ADA) 2017 Scientific Sessions.

CANVAS also known as DIA3008, is a prospective, double blind, placebo-controlled trial designed to evaluate the efficacy, tolerability and cardiovascular safety of canagliflozin in 4,330 adult patients with type 2 diabetes considered at elevated risk for cardiovascular disease. CANVAS participants (4,330 patients) were randomly assigned 1:1:1 ratio to placebo, canagliflozin 100 mg and canagliflozin 300 mg. CANVAS-R participants (5,812 patients) were randomly assigned 1:1 ratio to placebo or canagliflozin 100 mg.

According to the trial results, canagliflozin (Invokana) significantly reduced the combined risk of cardiovascular (CV) death, myocardial infarction (MI), and nonfatal stroke, versus placebo in patients with type 2 diabetes at risk for or with a history of CV disease. Canagliflozin reduced the overall risk of cardiovascular disease by 14 percent and reduced the risk of heart failure hospitalization by 33 percent. The drug also demonstrated potential renal protective effects and cuts the rate of renal decline by 40%.

CANVAS data also revealed a significant doubling in the risk for amputations, primarily of the toe or metatarsal (6.3 vs 3.4 cases per 1000 patient-years; hazard ratio, 1.97). That risk, already identified, led to a boxed warning for canagliflozin from the US Food and Drug Administration, and a warning on the labels of all SGLT2 inhibitors by the European Medicines Agency.

In addition, cardiovascular death was not significantly reduced in CANVAS, as it was in both EMPA-REG and the LEADER trial.

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