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FDA OKs Diabetes Drug for Type 2 Heart Failure Risk

heart monitor screen

Oct. 21, 2019—The FDA granted a new use for diabetes drug Farxiga (dapagliflozin): to reduce the risk of hospitalization for heart failure in adults who have type 2 diabetes and established heart disease or risk factors for it.

Farxiga is one of a group of drugs known as SGLT-2 inhibitors (sodium-glucose co-transporter 2). They lower blood sugar by causing the kidneys to remove sugar from the body via the urine.

"Generally speaking, I think medicines such as Farxiga definitely should be on the radar especially for our patients with heart failure," said Matthew Freeby, MD, director of the Gonda Diabetes Center at the UCLA David Geffen School of Medicine. In addition to reducing hospitalizations from heart failure, the drug also helps control of diabetes and reduces the risk of diabetes-related complications he said

According to AstraZeneca, Farxiga is the first such drug approved to reduce the risk of hospitalization for heart failure in people with type 2 diabetes. (Another SGLT-2, Invokana (canagliflozin), is approved to lower the risk of end-stage kidney disease, worsening kidney function, hospitalization for heart failure and cardiovascular death in adults with type 2 diabetes and diabetic kidney disease. A third in the group is Jardiance or empagliflozin, which is being studied as a heart failure treatment in people with chronic heart failure.)  

In a press release about the new Farxiga approval, AstraZenca's Ruud Dobber says, ''This is promising news for the 30 million people living with type 2 diabetes in the U.S., as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke."

Study of Farxiga & Hospitalization

The FDA granted the new use for Farxiga based on the results of a study called the DECLARE-TIMI 58 CV Outcomes trial. In that study, more than 17,000 patients with type 2 diabetes and heart disease or at risk for it were randomly assigned to get either the medication or placebo (an inactive pill). They were followed for more than 4 years.

People treated with the medication were 27% less likely to be hospitalized for heart failure than patients given placebo. There were no differences found in rates of heart attack, stroke or deaths from heart disease.

While Freeby says that benefit in reduced hospitalizations is modest, it is a benefit nonetheless. "I am using these medicines more and more because of the secondary benefit for cardiovascular disease."

Perspectives

"The whole issue of secondary benefit from this class of drugs evolved [over time, with more research],'' says Gerald Bernstein, MD, program coordinator of the Friedman Diabetes Institute, Lenox Hill Hospital, New York

"There is another drug out there that consumers should be aware of if they have cardiovascular problems and heart failure that appears to have benefit in reducing heart failure, and to the point it reduces the number of people going into the hospital. But, discuss it with your doctor."

Freeby says it's important to know the class of drugs has many benefits, but urges people to consider the risks and discuss those with their doctor. For Farxiga, those warnings include low blood pressure, kidney injury, very low blood sugar and other health problems, he says. Genital yeast infections and urinary tract infections (UTIs) are common side effects, which happen as Farxiga removes extra sugar into the urine.

The list price of Farxiga on the company's website is $492.41 for a 30-day supply. Health insurance, coupons, assistance programs and other factors may reduce those costs.  

WebMD Health News Reviewed by Brunilda Nazario, MD on October 22, 2019

Sources

Matthew Freeby, MD, director, Gonda Diabetes Center, David Geffen School of Medicine, UCLA.

Gerald Bernstein, MD, program coordinator, Friedman Diabetes Institute, Lenox Hill Hospital, New York.

AstraZeneca: Press release, Oct. 21, 2019.

The New England Journal of Medicine, Jan. 24, 2019.

Invokana web site.

AstraZeneca web site.

pharmaphorum.

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