November is widely known as American Diabetes Month – a month that ironically emerges amidst the piles of leftover Halloween candy and remnants of apple cider doughnuts. This time serves as a gentle reminder of the millions of people affected by diabetes every day, and the number is growing. In fact, according to the CDC’s 2014 Diabetes Report Card, about 1.7 million new cases of diabetes are diagnosed each year. Therefore, when a large, well-conducted trial shows a promising benefit with a new diabetes drug, the medical community takes note.
Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes was published in the New England Journal of Medicine and shows a lower rate of cardiovascular death in patients taking a drug called empagliflozin (Jardiance), as compared to placebo. The study focused on patients with Type 2 diabetes who were at high risk for cardiovascular events.
Three primary outcomes were measured – rates of heart attack, stroke, and cardiovascular death. While the drug did not appear to significantly lower heart attack or stroke, patients were less likely to die from any cause while on empagliflozin therapy. These results were shown very early on in the trial. The study also showed lower hospitalization rates for heart failure, possibly due to the way the drug works. This particular finding is of importance, since other diabetes medications have been associated with actually increasing rates of hospitalization due to heart failure. Since cardiovascular disease is a major cause of death in diabetic patients, the results of this study appear monumental. Lowering death rates is indeed the ultimate outcome for both the patient and physician.
What is empagliflozin?
The name itself is likely to cause stuttering, but empagliflozin – marketed under the brand name Jardiance – was approved in 2014 to improve blood sugar control in patients with Type 2 diabetes. The drug works somewhat differently than other conventional diabetes medications by targeting the kidneys and allowing glucose to be excreted in the urine. Older medications, like metformin and glipizide, work primarily on the liver and pancreas. The drug induces diuresis which may be why the trial proved advantageous in heart failure patients – it essentially eases the pressure off the heart.
Empagliflozin is available in two dosage strengths and is usually taken once a day in the morning. Because it targets the kidneys, people with kidney disease and elderly people over 75 are advised to be very cautious with this medication. Your doctor may decide if it is appropriate to use based on blood work to test the kidney function. Empagliflozin can also cause dehydration. It is very important to tell your doctor if you are on blood pressure lowering medications or a diuretic (“water pill”), as this could worsen your risk for dehydration. People over 65 years old are also at risk. Other more common side effects include urinary tract infections and yeast infections, most likely due to excess sugar passing in urine and attracting bacteria.
Synjardy, a combination of empagliflozin and metformin, was recently approved in August 2015. Approval came when another trial showed greater blood glucose control when empagliflozin was added to metformin. These two medications have complementary mechanisms of action, thus providing a greater benefit.
What does this mean?
Aside from its high cost, adding empagliflozin as an adjunct therapy for patients with Type 2 diabetes may become a new standard of care. Future analysis will need to determine how the price tag of the medication will affect this. Diabetes tends to be a disease state that requires multiple medications that work differently. Empagliflozin may not singly replace anything, but appears to be a superb add-on therapy, especially to metformin. Based on the side effects, the most appropriate patients would be middle-aged and otherwise healthy with no history of kidney disease. It is also important to note that while no study showed any major side effects, empagliflozin is still a new drug. If you are currently taking this medication, any side effect not mentioned in the package insert should be reported to the FDA.
- Centers for Disease Control and Prevention: www.cdc.gov
- Jardiance package insert
- Zinman B, Wanner C, Lachin J, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. The New England Journal of Medicine. September 17, 2015.
- Haring H, Merker L, Seewaldt-Becker e, et al. Empagliflozin as Add-On to Metformin in Patients With Type 2 Diabetes: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Trial. Diabetes Care. June 2014 vol. 37no. 6 1650-1659