Both patients with and patients without a history of cardiovascular events experienced a reduced risk of multiple cardiovascular-related outcomes.
James F List, MD, PhD
Canagliflozin (INVOKANA) has demonstrated an ability to reduce the risk of cardiovascular (CV) outcomes in patients regardless of a history of CV disease.
According to results of the CANVAS Program, presented at the 2017 American Heart Association (AHA) Scientific Sessions in Anaheim, California, the Janssen product reduced CV risks, in addition to reducing the risk for heart failure (HF) related hospitalizations as well as the risk of renal outcomes.
Data on the renal outcomes risk reduction was presented at the American Society of Nephrology Kidney Week 2017 Annual Meeting earlier this month.
"All people with type 2 diabetes have an increased risk of developing cardiovascular and renal diseases," James F List, MD, PhD, global therapeutic area head of cardiovascular & metabolism at Janssen, said in a statement. "This new CANVAS analysis is clinically important because it shows that INVOKANA may offer a broad range of patients an effective treatment option to reduce their risk of cardiovascular and renal disease."
The CANVAS Program examined 2 groups of patient with type 2 diabetes (T2D): those with (secondary; n = 6656) and those without (primary; n = 3486) a history of CV disease. Both the primary group (hazard ratio [HR] 0.82; 95% CI, 0.72-0.95) and the secondary group (HR 0.98; 95% CI, 0.74-1.30) saw a reduction compared to placebo, with no statistical evidence of between-group heterogeneity (P =.18).
The primary prevention group experienced CV death, nonfatal myocardial infarction, and nonfatal stroke at a rate of 9%, hospitalization for HF at a rate of 1.5%, and renal events at a rate of 2%. Overall, those in the secondary prevention group had greater absolute rates of CV, renal, and death outcomes than those in the primary prevention group.
Adverse events (AEs) were consistent across both groups (P >.07), and no new AEs were observed than what had been previously reported. The primary prevention group was slightly younger than the secondary group (63 years compared to 64 years), were more likely to be female (45% compared to 31%), and had a longer duration of T2D (14 years compared to 13 years).
As has been reported previously, the drug also reduced the risk of myocardial infarction, CV death, and nonfatal stroke by 14% (HR 0.86; 95% CI, 0.75-0.97; P =.0158).
Patients were randomized to either placebo, 100 mg canagliflozin, or 300 mg canagliflozin. Those given 100-mg doses were given the option to up-titrate if the 100-mg dose was well tolerated and additional glycemic control was necessary.
The drug is currently being evaluated further for renal outcomes in patients with T2D and kidney disease in the CREDENCE Program. In October, Janssen submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for a new indication the SGLT2 inhibitor, specifically for the reduction of the risk of major adverse cardiovascular events in adults with T2D.
In August, the FDA reinforced warnings of the drug's association with higher risks of amputation.