-- Scott Roberts
FRIDAY, Oct. 7 (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
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
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
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.
American Diabetes Association has more about
people with diabetes and high cholesterol.
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