The CANVAS results yield promise against cardiovascular events, but a risk of amputations.
The Canagliflozin Cardiovascular Assessment Study (CANVAS) results has shown that Type 2 diabetes mellitus (T2DM) patients have little concern for cardiovascular risks.
The study, a conglomeration of data with the Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM (CANVAS-R), returned results that showed adverse cardiovascular outcomes are at low risk compared to placebo.
Lead researcher Bruce Neal, MB, ChB, PhD, of the George Institute for Global Health, UNSW Sydney, said the Type 2 diabetes (T2D) medication reported a hazard rate of .86%, which "clearly proved" the study's primary hypothesis of safety and demonstrated superiority to similar medication.
However, the study was focused on patients with high-risk diabetes. During the canagliflozin trial, 15 amputations were required as a result of treatment. Neal, speaking from the American Diabetes Association 77th Scientific Sessions in San Diego, noted 10 of those amputations would be of patients' toes or forefoot area. The other 5 would be amputations above the ankle.
"We believe that for most patients with diabetes at high risk, there's going to be a net positive benefit-risk ratio," Neal said. "But there's going to be a subset of patients that are at very high risk of amputation for whom this is probably not going be the drug of choice."