(RxWiki News) The US Food and Drug Administration (FDA) has expanded the approval of a drug to treat adults who have heart failure.
Jardiance (empagliflozin) received approval as a glucose control medication in adults with type 2 diabetes back in 2014. The FDA also approved it to prevent death in patients who had both type 2 diabetes and heart disease.
Now, the FDA has approved Jardiance to prevent cardiovascular death and hospitalization for heart failure in all adults — not just those with type 2 diabetes.
“Today’s approval will provide a treatment option for a wider range of patients with heart failure,” said Dr. Norman Stockbridge, director of the FDA's Division of Cardiology and Nephrology, in a press release. “While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure."
Heart failure occurs when your heart is unable to keep up with the cardiovascular needs of your body. According to the FDA, this condition affects more than 650,000 American adults each year.
Now, those adults may have one more viable treatment option.
The FDA assessed Jardiance's safety and effectiveness as a treatment for heart failure in a study of nearly 6,000 adults with heart failure. Roughly half received Jardiance, and the other half received a placebo.
Among the patients who received Jardiance for roughly two years, 14 percent died from cardiovascular causes. In the placebo group, that figure was 17 percent. The FDA noted that the decrease in deaths tied to Jardiance appeared to be due to a reduced number of hospitalizations tied to the drug.
Side effects of Jardiance included urinary tract infections and female fungal infections. The FDA noted that this drug cannot be used in patients who have had a serious allergic reaction to it in the past or those who are on dialysis.
Talk to your doctor about the best available treatments for your heart condition.
The FDA approved Jardiance for Boehringer Ingelheim.