FDA Approves Jardiance to Treat Cardiovascular Disease in Diabetes Patients

The diabetes drug empagliflozin (Jardiance) is now a ''double duty'' drug. It can be prescribed not only to help treat diabetes, but also to reduce the risk of cardiovascular death in adults diagnosed with both type 2 diabetes and cardiovascular disease.1


The FDA granted approval for this new indication in December, after reviewing a study of 7,000 patients with both conditions. 2

Doctors call this a major advance for these patients and say it has changed prescribing practices.

A look at the statistics suggests why. A diagnosis of type 2 diabetes raises the risk of cardiovascular disease, and the presence of both increases the risk of death.3 Death from cardiovascular disease is about 70 % higher in those with diabetes than those without, the Centers for Disease Control and Prevention estimates.

"It is a relief to have a drug for diabetes that has been shown to reduce the risk of cardiovascular death in those with type 2 diabetes mellitus and cardiovascular disease," says Caroline Apovian, MD, FACP, FACN, professor of medicine and pediatrics, Boston University School of Medicine and director, Nutrition and Weight Management Center at Boston Medical Center. She is a member of the EndocrineWeb editorial board. She has no ties to the makers of the drug.

About Jardiance

Jardiance is a type of drug known as a sodium glucose cotransporter-2 inhibitor (SGLT). The FDA first OK'd it as a diabetes drug when used in combination with diet and exercise to improve blood sugar control in adults with type 2 diabetes in 2014. 2 It works by blocking the reabsorption of excess glucose by the kidney, leading to more glucose being excreted in the urine. 4

Two other SGLT-2 inhibitors are approved to treat type 2 diabetes—canagliflozin (Invokana) and dapagliflozin (Farxiga).

When the FDA approved Jardiance, it required the company to do the post-market study to evaluate the drug's effect on cardiovascular safety. 2

More on the Study

In the study of 7,000 patients, their A1C was between 7 and 10%. The researchers randomly assigned the patients either to a dose of the drug (10 milligrams or 25 mg) or a placebo pill daily for a median of three years (half longer, half less). The patients also took a variety of medicines for their cardiovascular disease, such aspirin, cholesterol-lowering statins and blood pressure drugs.

The main focus of the researchers was to find out if the drug reduced the risk of death from cardiovascular causes and if it also reduced the risk of having a non-fatal heart attack or non-fatal stroke. 3

Study Results

Jardiance did better than placebo at reducing the risk of cardiovascular death, says Thomas Seck, MD, an endocrinologist and vice president of clinical development and medical affairs for Boehringer Ingelheim Pharmaceuticals, which markets the drug together with Eli Lilly and Company.

"Overall, the risk reduction was 38%," Dr. Seck told EndocrineWeb. He terms that an ''almost dramatic reduction in cardiovascular death'' when compared to other interventions. Those in the drug-treated group were 38% less likely to die from cardiovascular problems than those in the placebo group.

Compared with placebo, Jardiance also reduced the risk of death from any cause by 32% during the study follow up. It reduced the risk of hospitalizations for heart failure, too. Between the two groups, however, there were no significant differences in non-fatal heart attacks or strokes.3

Jardiance Pros and Cons

In 2016, an advisory panel of the FDA considered the new indication for reducing cardiovascular death. The experts narrowly endorsed the approval by a vote of 12 to 11. Some who voted no cited reservations in granting approval for the new indication based on a single study. 

Like all drugs, Jardiance has potential side effects. It can cause dehydration and low blood pressure and lead to urinary tract infections, kidney injury and problems with kidney function, as well as vaginal yeast infections and blood cholesterol problems.

Those with type 1 diabetes cannot use it, nor can those with serious kidney problems.

Experts can explain for sure how it works to reduce deaths. The study of 7,000, published in the New England Journal of Medicine, was designed to study if the drug helped reduce those deaths, but not how. However, researchers familiar with the drug speculate that it may help prevent cardiovascular death in a number of ways, such as reducing the stiffness of blood vessels and improving heart functioning.3

More Perspective on Jardiance's Double Duty

Many doctors are approaching the treatment of patients with diabetes, as well as those with diabetes and cardiovascular disease, differently now, Dr. Apovian says. That's partly due to the new indication for Jardiance, but also to information showing that the SGLTs have been shown not only to improve diabetes management but also to promote weight loss, she says.

For those reasons, Jardiance, as well as other SGLTs, are often prescribed first, along with other blood sugar lowering drugs, before resorting to insulin or other drugs, she says.

"The new paradigm of care for type 2 diabetes is to use treatments that not only improve the blood sugars, but also have beneficial effects on the weight," agrees J. Michael Gonzalez-Campoy, MD, PhD, FACE, medical director and CEO of the Minnesota Center for Obesity, Metabolism and Endocrinology. He is a member of the editorial board of EndocrineWeb.

Dr. Gonzalez-Campoy was one of the investigators on the Jardiance trial of cardiovascular benefits and has long prescribed the SGLT-2 medications. The drugs accomplish many benefits, he says, including lowering blood sugar and blood pressure and improving cholesterol levels. "Not surprisingly," he says, ''these beneficial effects do translate into decreased cardiovascular risk."



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Diabetes Drug Jardiance Reduces Heart Disease Death