Johnson & Johnson‘s type 2 diabetes drug Invokana significantly reduced the risk of serious heart problems in patients with established heart disease or at elevated risk in a pair of large studies, according to data presented at a medical meeting on Monday.
The medicine also led to a reduced risk of hospitalization for heart failure and protection against kidney function decline. But the risk of amputations, particularly of toes or feet, was double versus placebo in the studies of 10,142 patients with type 2 diabetes.
On the study’s main goal Invokana, known chemically as canagliflozin, reduced the combined risk of heart-related death, nonfatal heart attack and nonfatal stroke by a statistically significant 14 percent compared with placebo.
“What we actually got here was not just evidence of safety but evidence of benefit,” said lead investigator Bruce Neal, professor of medicine at the University of New South Wales Sydney.
“It’s a really positive result. This (heart disease) is the main thing that people with diabetes die from,” said Neal, who presented the data at the American Diabetes Association meeting in San Diego.
The study was required to prove Invokana did not cause heart complications. The expectation bar was raised, however, after rival drug Jardiance from Eli Lilly and Co and Boehringer Ingelheim in 2015 demonstrated heart protective qualities in a similar large trial. Reduction of heart-related death is now included in the Jardiance label.