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Spokane, Washington  Est. May 19, 1883

New diabetes drug ‘amazing’

Study: Medication lowers risk of heart attack, stroke

Melissa Healy Los Angeles Times

A new drug drives down the likelihood that diabetic patients with established cardiovascular disease will suffer or die of heart attack, stroke or heart failure, a new study finds.

Compared with clinical trial subjects who took a placebo medication, those who added the drug empagliflozin – marketed as Jardiance – to their regimen of diabetes medications were 38 percent less likely to suffer a fatal or nonfatal “cardiovascular death” (heart attack, stroke or heart failure) during the roughly three years subjects were tracked.

The study found that those taking Jardiance were 35 percent less likely to be hospitalized for heart failure than were subjects who took a placebo pill instead. And they were 32 percent less likely to die of any cause.

The results of the clinical trial astonished physicians, who have been pummeled in recent years by a litany of disappointing findings about diabetes treatments. Four major clinical trials involving other diabetes medications in recent years have shown that those treatments improve patients’ metabolic function. But in each case, that improvement has failed to translate into fewer heart attacks, strokes or cardiovascular deaths.

In some cases, those medications were linked to higher death rates from heart attack and stroke.

“It’s an amazing result, very unexpected and wonderful news,” said Dr. Christopher Cannon, a cardiologist at Brigham & Women’s Hospital in Boston, who was not involved with the study.

Cleveland Clinic cardiologist Steven Nissen hailed the new findings as a “blockbuster result.”

“This is the first time ever that a diabetes drug has shown evidence of cardiovascular benefit,” said Nissen, who eight years ago prodded the Food and Drug Administration to change its standards for evaluating diabetes medications and require them to undergo cardiovascular safety trials. “Obviously, this is an important finding.”

Empagliflozin is the third of a new class of diabetes drugs that reduce blood sugar in diabetics by facilitating its excretion in urine. It won U.S. marketing approval in August 2014 from the FDA and is one of about 40 medications approved for the treatment of diabetes.

Jardiance’s sponsors – Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Co. – conducted the new study, called the EMPA-REG outcome trial, on orders from the FDA.

The results were presented Thursday to a meeting of the European Association for the Study of Diabetes in Stockholm, Sweden, and published simultaneously in the New England Journal of Medicine.

The latest trial results suggest that for every 39 diabetic patients with established cardiovascular disease who are treated with Jardiance, one death might be averted.

The participants in the EMPA-REG outcome trial were at unusually high risk of early cardiovascular death, so it’s hard to draw clear comparisons with other drugs.

But the “number-to-treat” figure calculated by the study’s authors puts the drug’s effectiveness in preventing cardiovascular death close to that of lipid-lowering statin medications, introduced in the 1980s, and possibly ahead of ACE inhibitors, a widely used class of hypertension medications, said Dr. Silvio Inzucchi, a Yale Medical School endocrinologist who is among the paper’s authors.

Since such medications are already in wide use among diabetes patients, physicians had begun to fear they would be hard-pressed to drive heart attacks and strokes much lower, said Inzucchi.

The results of the trial – that adding Jardiance to a diabetic’s existing treatment regime could do so – has sparked jubilation among study investigators, he said.

“It’s almost like, how much more benefit can you get?” said Inzucchi in a telephone interview from Stockholm. “Personally, I was shocked by the findings.”