In a nutshell
This study examined the safety and effectiveness of empagliflozin (Jardiance) in patients with type 2 diabetes and hypertension (high blood pressure).
Some background
Type 2 diabetes is associated with a 67–78% lifetime risk of cardiovascular disease. Hypertension (high blood pressure) affects roughly two thirds of patients with type 2 diabetes, and increases the risk of developing cardiovascular disease. Lowering blood pressure can decrease that risk. Most treatments for type 2 diabetes focus on lowering blood glucose (sugar) levels, as high levels can also increase the risk of complications, including cardiovascular disease.
Empagliflozin is a drug that has recently been approved for treating type 2 diabetes in adults. It decreases blood glucose levels by increasing the amount of glucose that is removed from the body through urine. Empagliflozin has also been shown to decrease blood pressure and increase weight loss.
Methods & findings
The current study examined the safety and effectiveness of empagliflozin in patients with type 2 diabetes and hypertension. 823 patients were randomly assigned to one of three groups: 276 received 10 mg of empagliflozin, 276 received 25 mg of empagliflozin, and 271 received a placebo (a substance that has no effect on the body used as a comparison). Changes in blood glucose, blood pressure, and weight were measured after 12 weeks of treatment. The number of adverse events were also recorded.
Both doses of empagliflozin led to significant reductions in blood pressure compared to placebo. Patients with average blood pressures greater than 130/80 mmHg at the beginning of the study saw a larger decrease after treatment with 25 mg of empagliflozin (decrease of 6.33/2.56 mmHg) than patients with average blood pressures lower than 130/80 mmHg (decrease of 0.22/0.22 mmHg).
HbA1c levels (average blood glucose over 3 months) decreased significantly with both doses of empagliflozin compared to placebo, as did body weight. In the 25 mg group, the average HbA1c decreased by 0.62%, and the average body weight decreased by 2.16 lbs.
Of the patients who experienced an adverse event, 97% were reported as mild to moderate. The most frequently seen adverse events included pollakiuria (frequent urination), hypoglycemia (dangerously low blood glucose levels), polyuria (increased amount of urine) and thirst.
The bottom line
This study concluded that empagliflozin was a safe and effective treatment for patients with type 2 diabetes and hypertension.
The fine print
This study was funded by Boehringer Ingelheim and Eli Lilly, the manufacturers of empagliflozin.
Published By :
Diabetes Care
Date :
Sep 30, 2014
