Canagliflozin (Invokana, Janssen Pharmaceutical) significantly reduced the risk of cardiovascular death or hospitalization for heart failure in patients with type-2 diabetes at high cardiovascular risk in an exploratory analysis from the CANVAS clinical program, according to a presentation at the American College of Cardiology's 67th Annual Scientific Session that was simultaneously published in Circulation.
"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," said Javed Butler, MD, MPH, Chairman of Medicine at the University of Mississippi.
The results showed canagliflozin was associated with a significant reduction in risk of cardiovascular (CV) death or hospitalization for heart failure (HHF) by 22% (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.67–0.91), fatal or hospitalized heart failure by 30% (HR, 0.70; 95% CI, 0.55–0.89); and HHF alone by 33% (HR, 0.67; 95% CI, 0.52–0.87). The benefit of reduced risk of CV death or HHF was 39% (HR, 0.61; 95% CI, 0.46–0.80) greater in patients with a prior history of heart failure, compared to the 13% (HR, 0.87; 95% CI, 0.72–1.06) 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.
In addition, the data confirmed that proportional effects of canagliflozin compared to placebo were comparable across a broad population of patients with type-2 diabetes 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.
On October 2, 2017, Janssen submitted a supplemental new drug application to the FDA seeking a new indication to reduce the risk of MACE based on the CANVAS program.
Source: Janssen Pharmaceutical; March 11, 2018.