CANVAS Program

RE: CANVAS Program main results

• We were excited to report the CANVAS Program main results at the recent meeting of the American Diabetes Association in San Diego, and to simultaneously publish the findings in the New England Journal of Medicine. Downloads are available at: 

• Paper - http://www.nejm.org/doi/full/10.1056/NEJMoa1611925#t=article), and

• Slide deck – www.georgeinstitute.org 

• The CANVAS Program data provide a great deal of new insight into the efficacy and safety of canagliflozin. As you are likely aware, the key finding was a 14% reduction in the primary composite cardiovascular outcome of cardiovascular death, heart attack or stroke (HR: 0.86; 95% CI: 0.75 to 0.97). While significant effects were not demonstrated for the secondary outcomes of all-cause mortality (HR: 0.87; 95% CI: 0.74, 1.01) or cardiovascular death (HR: 0.87; 95% CI: 0.72, 1.06) the data for every vascular outcome were suggestive of benefit, and particularly so for heart failure and kidney disease. More reliably defining the effects of canagliflozin on kidney disease is the focus of the ongoing CREDENCE study. There was also a risk of amputation with canagliflozin (HR: 1.97; 95% CI: 1.41 to 2.75). In 71% of cases amputation was of toes and meta-tarsals and in 29% at the ankle or above. The FDA issued an updated Drug Safety Communication about amputation on 16 May 2017, which can be found here: 

• https://www.fda.gov/downloads/Drugs/DrugSafety/UCM558427.pdf.

• We would like to once again thank you for your contribution to the successful execution of this clinical trial program. Please also extend our appreciation to the participants at your site, without whom this important new data could not have been generated. We will be in touch again in a couple of months’ time, once the clinical study reports are complete, with the individual treatment assignments for the patients. In the meantime, if you have any questions please let us know.

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• Sincerely,

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• Bruce Neal, MB ChB, PhD                                                             David Matthews, DPhil, BM, BCh 

• CANVAS Steering Committee Co-Chair                                      CANVAS Steering Committee Co-Chair