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The FDA has granted the diabetes drug liraglutide (Victoza) a new indication: reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, .
Approval was based on findings from the LEADER trial, which showed a 13% reduction in the risk of a composite of cardiovascular death, non-fatal heart attack, and non-fatal stroke compared with placebo, with an absolute risk reduction of 1.9%, the company noted.
Novo Nordisk said the composite results were driven by a significant 22% reduction in cardiovascular death; reductions in heart attack and stroke weren't significant.
Liraglutide is the second diabetes drug to score a cardiovascular indication. Last December, empagliflozin (Jardiance) was approved to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and cardiovascular disease, based on the results of the EMPA-REG study.
The diabetes drug semaglutide has also been shown to reduce the risk of major adverse cardiovascular events in the SUSTAIN 6 trial, but is not yet approved in the U.S. for any indication. Canagliflozin (Invokana) was shown to reduce the risk of cardiovascular events in the CANVAS trial, but hasn't yet received a cardiovascular prevention indication.
Cardiovascular outcomes trials with several other diabetes drugs -- including alogliptin (EXAMINE), saxagliptin (SAVOR), sitagliptin (TECOS) and lixisenatide (ELIXA) -- have had null effects.
The LEADER trial included 9,340 patients with type 2 diabetes from 32 countries, and began enrollment in September 2010. Patients were followed for a minimum of 42 months.
In June, an FDA advisory panel voted 17-2 that liraglutide reduced cardiovascular risk, but panelists raised concerns about a subgroup analysis that showed an increase in major adverse cardiovascular events among patients in the U.S. on the drug, compared with those from other countries.