The Janssen Pharmaceutical Companies of Johnson and Johnson announced results of new analysis exhibiting that INVOKANA remarkably lessened the risk of cardiovascular death or hospitalization for heart failure in patients with type 2 diabetes at high CV risk.
Exploratory analysis from the CANVAS program was featured as a oral presentation at the American College of Cardiology’s 67th Annual Scientific Session and was simultaneously published in Circulation.
Javed Butler, M.D., M.P.H., Chairman of Medicine at University of Mississippi said “These results add to the body of evidence suggesting that canagliflozin has clinical benefit in patients with type 2 diabetes who are also at risk for some of the major cardiovascular complications.”
The results exhibited that canagliflozin was associated with a significant reduction in risk of CV death or HHF by 22 percent (HR, 0.78; 95% CI, 0.67 to 0.91), fatal or hospitalized heart failure by 30 percent (HR, 0.70; 95% CI, 0.55 to 0.89); and HHF alone by 33 percent (HR, 0.67; 95% CI, 0.52 to 0.87). The advantage of reduced risk of CV death or HHF was 39% greater in patients with a prior history of heart failure, compared to the 13 percent (HR, 0.87; 95% CI, 0.72 to 1.06) without heart failure, at baseline.
Rates of heart failure varied according to baseline characteristics, such as age, renal function and other disease history characteristics, but effects of canagliflozin on risk of CV death or HHF were mostly comparable across numerous subgroups.
Data testified that proportional effects of canagliflozin compared to placebo were comparable across a broad population of patients with T2D at high CV risk. Specifically, patients from the CANVAS Program included those with and without heart failure at baseline for major adverse CV events (MACE), CV death, myocardial infarction (MI), stroke, all-cause mortality, and serious decline in kidney function.
Janssen submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking a new indication to reduce the risk of MACE based on the CANVAS Program.