If you have type 2 diabetes, your doctor has told you that you're at increased risk for cardiovascular disease. The statistics are scary and sobering. And it's not just a risk of having heart attacks and strokes—it's a very real risk of dying from cardiovascular disease. Death from cardiovascular disease is about 70% higher in those with diabetes than in those without, the Centers for Disease Control and Prevention says.1
But there's a recent bright spot: In December, the FDA extended the approval for empagliflozin (Jardiance), a diabetes drug approved in 2014. It is now approved also to reduce the risk of dying from cardiovascular disease in adults with both conditions.2
It is "a relief'" to have this double-duty drug that both treats diabetes and reduces the risk of cardiovascular death in those coping with both diabetes and cardiovascular problems, says Caroline Apovian, MD, FACP, FACN, professor of medicine and pediatrics at the Boston University School of Medicine and director of the Nutrition and Weight Management Center at Boston Medical Center. She is on the editorial board for DiabeticLifestyle and has no ties with the drug's makers.
Here, what else to know.
With the assortment of drugs available to treat type 2 diabetes, it isn't easy to keep them all sorted out. Jardiance belongs to a class known as SGLT-2 inhibitors (sodium glucose cotransporter-2). If you have type 2 diabetes, your kidneys may be holding onto too much glucose, raising the level of sugar in your blood.
Jardiance blocks the reabsorption of some excess sugar by the kidney, and that glucose leaves your body when you urinate. 3
The FDA OK'd Jardiance in 2014 for adults with type 2 diabetes. At that time, they required a post-market study to look at effects on cardiovascular health. 4
Besides Jardiance, two other SGLT-2 inhibitors are on the market—canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga). Currently, the others are not FDA-approved to reduce the risk of cardiovascular death in those with type 2 diabetes and cardiovascular disease. 5
The study on Jardiance looked at 7,000 adults, all with type 2 diabetes and cardiovascular diseases. The researchers assigned half of the people to take Jardiance (either 10 or 25 milligrams a day) or a placebo or sugar pill. No one knew which pill they were taking. For their heart-related issues, they also took other drugs, such as aspirin or statins to lower their cholesterol. 6
The primary question was: did Jardiance reduce that risk of dying from cardiovascular disease? The researchers found it did. "Overall, the risk reduction was 38%," says Thomas Seck, MD, an endocrinologist and vice president of clinical development and medical affairs for Boehringer Ingelheim Pharmaceuticals, which markets the drug with Eli Lilly and Company.
Those taking the active drug were 38% less likely to die of cardiovascular disease during the follow up period of about three years than those who got the sugar pill. 5
The researchers also looked at non-fatal heart attack and stroke and found no benefit to taking the drug for those results. The drug-treated group was less likely than the placebo group to be hospitalized for chest pains or angina.7
The approval of Jardiance for reducing the risk of death was based on a single study. It was a large study, but the fact that it was only one study posed an issue for some on the FDA's advisory panel voting whether to approve the new indications or not. The vote was 12 to 11 in favor of approval. The FDA is not bound to follow the recommendations of its advisory panels but typically does so.
However, Dr. Seck says that the results of the post-market study ''really reconfirms the safety we have seen before for Jardiance."
Like all drugs, Jardiance has potential side effects. These may include dehydration and low blood pressure, urinary tract or genital yeast infections and kidney injury. Blood sugar may drop too low if it's used in combination with insulin or some other drugs. 8
"If you have damaged kidney function, this [drug] is not indicated," Dr. Seck says.
The FDA approval of this new indication for Jardiance is already changing prescribing practices, says Dr. Apovian. The new approach, she says, is to try SGLT2 inhibitors and other drugs before resorting to insulins and the class of drugs known as sulfonylureas. That's because the SGLT2 drugs have been shown to help diabetes management and also help with weight loss, she says.
There is definitely a new paradigm of care for treating type 2 diabetes, agrees J. Michael Gonzalez-Campoy, MD, PhD, FACE, medical director and CEO of the Minnesota Center of Obesity, Metabolism and Endocrinology. He serves on the DiabeticLifestyle editorial board.
He was one of the researchers for the cardiovascular study of Jardiance. He has experience both as a researcher and a physician who adapted these SGLT-2 inhibitors early due to their benefits. The drugs make it possible, he says, to treat patients with an oral agent and see lowering of blood sugar, blood pressure and insulin and improvement in cholesterol levels. "Not surprisingly, these beneficial effects do translate into decreased cardiovascular risk," he says.