The FDA has approved canagliflozin (Invokana) to reduce the risk of major adverse cardiovascular events (MACE) including stroke, heart attack and cardiac death in patients with type 2 diabetes and established cardiovascular disease. It is the first oral diabetes medication to gain this indication, according to an Oct. 30 announcement from drug manufacturer Janssen Pharmaceutical Companies.
Another drug in the same class, Boehringer Ingelheim's empagliflozin (Jardiance), has been approved to reduce the risk of cardiovascular death in patients with type 2 diabetes and established CVD.
“It is an important step forward for patients and the physicians who treat them,” said James List, MD, PhD, with the Cardiovascular & Metabolism arm of Janssen Research & Development. “Not only does Invokana enable patients to control their diabetes symptoms by lowering their A1C levels, but it now also helps protect them from potentially devastating cardiovascular events."
The expanded indication came on the basis of the CANVAS trial, which was published in the New England Journal of Medicine in August 2017. That study included 10,142 participants with type 2 diabetes and either established CVD (65 percent) or at least two cardiovascular risk factors (35 percent).
Treatment with the drug versus placebo—in addition to standard-of-care therapy—was associated with a relative 14 percent reduction in the combined risk of CV death, stroke or myocardial infarction. Canagliflozin appeared to be even more protective in the subgroup with established CVD, achieving an 18 percent risk reduction compared to placebo medication.
Each component of the primary endpoint was lowered with the sodium-glucose cotransporter-2 (SGLT2) inhibitor—nonfatal heart attacks were reduced by 15 percent, strokes by 10 percent and CV deaths by 13 percent.
"Americans living with type 2 diabetes are two to three times more likely to die from heart disease than adults without diabetes," said Ralph DeFronzo, MD, a diabetes specialist who wasn’t involved in the CANVAS study but was quoted in Janssen’s news release. "With this approval, Invokana now plays an even more important role in the overall treatment mix with its demonstrated ability to reduce the risk of potentially devastating cardiovascular events.”
The FDA’s new indication applies to both the fixed-dose and extended-release combinations of canagliflozin, according to Janssen.