New type 2 diabetes/cholesterol drug approved
October 7th, 2011
02:31 PM ET

New type 2 diabetes/cholesterol drug approved

A new combination drug to treat both type 2 diabetes and high cholesterol was approved by the Food and Drug Administration Friday.  Juvisync  combines the blood sugar lowering drug  sitagliptin or Januvia with the cholesterol lowering drug  simvastatin sold under the brand name Zocor.

"This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet," said Dr. Mary H. Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. "However, to ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients. Dose selection should factor in what other drugs the patient is taking."

The three dosage strengths approved for sitagliptin/simvastatin were 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg.  The manufacturer, Merck & Co., will also develop additional fixed-dose combinations with a 50 mg dose of sitagliptin, the diabetes medication.  There are currently no plans to increase or decrease the simvastatin dose.

The FDA has looked at the possibility that statins could raise blood sugar levels in type 2 diabetics, but it says the risk is small and doesn't outweight the benefits statins provide in reducing heart disease in patients with diabetes. 

Approximately 20 million Americans have type 2 diabetes and many of those also have high cholesterol, according to the FDA.  Both are conditions that increase the risk of heart disease, kidney disease and stroke.  Diabetics face a 2 to 4 times greater risk of stroke and death due to heart disease than people without diabetes, according to the American Diabetes Association.

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