In a nutshell
This study investigated the safety of empagliflozin (Jardiance) in patients with type 2 diabetes (T2D). It was determined that empagliflozin is a safe drug, but may increase the risk of genital infections.
Some background
Empagliflozin is an SGLT2 inhibitor. SGLT2 is a protein in the kidneys that is important in controlling blood glucose levels. It allows glucose to re-enter the blood from the kidneys. SGLT2 inhibitors are a type of treatment that prevents this. The safety of empagliflozin is still under investigation.
Methods & findings
The results of 15 studies investigating the safety of empagliflozin were examined in this study. Overall, 12,620 adults with T2D participated in these studies. These participants were randomly divided into 3 groups. One group received a placebo (drug with no active effect). Another group received empagliflozin at a dose of 10 mg. The other group received empagliflozin at a dose of 25 mg. The participants were treated for an average of 2.6 years. Side effects were reported to investigators in each of the studies.
Hypoglycemia (dangerously low blood glucose) occurred at a similar rate in patients in all groups, except for patients who were treated with empagliflozin and a sulfonylurea. These patients were more likely to experience hypoglycemia than the placebo group. Sulfonylureas are drugs that decrease blood glucose by increasing the amount of insulin released from the pancreas. Urinary tract infections (such as bladder or urethra infections) occurred at a similar rate in all groups. Genital infections were reported more frequently in patients treated with empagliflozin than in the placebo group. In 99% of cases these infections were mild or moderate.
Low blood pressure occurred at a similar rate in all three groups for most participants. Participants who were 75 years or older, or who were also taking a loop diuretic (drug that lowers blood pressure) were more likely to report low blood pressure if they were taking empagliflozin than if they were taking a placebo.
Cancer, kidney disease, liver disease, bone fractures, diabetic ketoacidosis (life-threatening complication of diabetes), damage to the pancreas, and amputations involving the lower limb occurred at a similar rate in all groups.
The bottom line
The study concluded that empagliflozin is safe, but may increase the risk of genital infections, compared to placebo.
The fine print
This study was funded by the manufacturers of empagliflozin. Differences between the studies (such as duration of treatment) make comparisons between them difficult.
What’s next?
Discuss the safety of empagliflozin with your physician.
Published By :
Advances in therapy
Date :
Jun 19, 2017
