Jardiance, a prescription medicine used along with diet and exercise to lower blood sugar, can now be prescribed to reduce the risk of cardiovascular death in adult patients with Type-2 diabetes and cardiovascular disease, the US Food and Drug Administration (FDA) has ruled.
"Cardiovascular disease is a leading cause of death in adults with Type-2 diabetes mellitus," Jean-Marc Guettier from FDA's Center for Drug Evaluation and Research, said in a statement on Friday.
"Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with Type-2 diabetes," Guettier said.
The FDA's decision is based on a postmarketing study required by the agency when it approved Jardiance in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with Type-2 diabetes mellitus.
Jardiance, also known as empagliflozin, was studied in a postmarket clinical trial of more than 7,000 patients with Type-2 diabetes and cardiovascular disease.
In the trial, Jardiance was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard of care therapies for diabetes and atherosclerotic cardiovascular disease.
According to the US Centers for Disease Control and Prevention, death from cardiovascular disease is 70 per cent higher in adults with diabetes compared to those without diabetes, and patients with diabetes have a decreased life expectancy driven in large part by premature cardiovascular death.
The most common side effects of Jardiance, distributed by Boehringer Ingelheim Pharmaceuticals, are urinary tract infections and female genital infections.
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