Juvisync Approved for Type 2 Diabetics With High Cholesterol
Previously approved meds combined in one tablet
FRIDAY, Oct. 7, 2011 (HealthDay News) -- Juvisync (sitagliptin and simvastatin) has been approved by the U.S. Food and Drug Administration for people with type 2 diabetes who also have high cholesterol.
The single pill combines two previously approved drugs, Januvia and Zocor. Some 20 million people in the United States have type 2 diabetes, and many also have high cholesterol. The conditions, especially if left untreated, can increase a person's risk of heart disease, stroke, kidney disease and blindness, the agency said in a news release.
The FDA noted that recent studies have suggested that statins, of which simvastatin is one, may prompt a rise in blood sugar levels among people with type 2 diabetes. But "this risk appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes," the agency said, noting it would require Juvisync's label to alert doctors to this possibility.
The FDA said it also would require Merck & Co. to conduct post-approval studies that compare sitagliptin alone with the combination drug in lowering blood glucose levels.
The most common side effects of Juvisync are upper respiratory infection, stuffy nose, sore throat, headache, muscle and stomach pain, constipation and nausea, the agency said.
The American Diabetes Association has more about people with diabetes and high cholesterol.