J&J's Invokana Lowers Heart Issues, Raises Amputation Risk
Zacks Investment Research | Jun 12, 2017 09:49PM ET
Johnson & Johnson (NYSE:JNJ) announced data from a large CANVAS outcomes program, which demonstrated that its type II diabetes drug Invokana (canagliflozin) was successful in reducing the risks of heart attacks and strokes. However, the study also showed that the drug increased the risk of amputations.
The data were presented at the annual meeting of the American Diabetes Association and published by the New England Journal of Medicine.
The CANVAS program comprised two, nearly-identical large outcomes studies called CANVAS and CANVAS-R.
Data from the CANVAS CV outcomes study showed that its SGLT2 inhibitor, Invokana reduced major adverse CV events or MACE by 14% versus placebo in diabetes patients at risk for or with a history of CV disease. MACE is a composite endpoint of CV death, non-fatal myocardial infarction or non-fatal stroke.
While the risk of CV death was reduced by 13% that of nonfatal MI and nonfatal stroke was reduced by 15% and 10%, respectively. The data also showed that Invokana reduced risk for hospitalization for heart failure (HHF). Meanwhile, the study also demonstrated the CV safety of Invokana and superiority compared to placebo
On the other hand, CANVAS-R study showed that Invokana was beneficial in delaying progression of albuminuria and reducing the risk of renal death and renal replacement therapy.
However, an increased risk of amputations was identified in both the studies, which was almost double that of placebo. The observation was consistent with the black boxed warning on Invokana’s label on the increased amputation risk associated with the use of the drug.
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