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Fluids & Electrolytes
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 cholesterol.
The FDA noted that recent studies have suggested that statins 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 Juvisync's manufacturer, the Irish drugmaker MSD International, 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, congestion, 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.
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