ORLANDO – Eli Lilly's new diabetes drug Jardiance significantly cut the risk of heart-related death and hospitalization for heart failure in patients with type 2 diabetes who are at high risk for serious heart problems, according to data from a large study presented on Monday.
The 3-year trial of more than 7,000 patients caused a sensation in September, when Lilly and Jardiance partner Boehringer Ingelheim released preliminary data showing the drug cut deaths by 32 percent.
Earlier, similar studies of other types of diabetes medicines were undertaken to prove they did not cause heart problems, and a neutral outcome was considered reassuring.
The new data showed Jardiance, known chemically as empagliflozin, reduced the combined risk of hospitalization for heart failure or death from heart failure by 39 percent, compared with a placebo when added to standard treatments.
The benefits were seen in those who had heart failure at the start of the study and those who did not. Heart failure, a progressive condition in which the heart becomes unable to pump enough blood, is a leading cause of hospitalizations and death.
"To see a (diabetes) drug that is not only beneficial overall on cardiovascular impact but also minimizes hospitalization for heart failure is quite novel and quite encouraging," said Dr. Silvio Inzucchi, who presented the data at the American Heart Association scientific meeting in Orlando. He called the results impressive and unanticipated.
People with diabetes are two to three times more likely to develop heart failure than those without diabetes, researchers said. Because about half of deaths in people with type 2 diabetes are caused by heart disease, reducing heart risk is considered essential to diabetes care.
Nearly half the patients in the study were on insulin, an indication that their diabetes was at an advanced stage.
The benefits of Jardiance appeared almost immediately, Inzucchi said.
"The event curves begin to diverge almost on day one," he said. "There seems to be something about this medication that has a very early impact."
Researchers do not know what caused the dramatic effect.
Jardiance, a once-a-day pill, belongs to a new class of treatments called SGLT2 inhibitors that remove blood sugar through the urine. The class includes Johnson & Johnson's Invokana and AstraZeneca's Farxiga.
"Patients with advanced diabetes ... who have lots of heart disease clearly benefited from going on the drug," Inzucchi said. "We must incorporate this type of evidence into our treatment decisions."