New Combination Drug For Diabetes, Cholesterol Approved
October 8, 2011

New Combination Drug For Diabetes, Cholesterol Approved

Regulators from the U.S. Food and Drug Administration (FDA) have approved a new combination drug that will combine medicines used to treat diabetes and reduce cholesterol, various media outlets reported on Friday.

According to Alina Selyukh of Reuters, the new drug comes from Merck and is called Juvisync. It will combine the company's product Januvia, a medicine used to lower high blood sugar in type 2 diabetes patients, with simvastatin, a "commonly prescribed statin" which is used in combination with diet and exercise to lower cholesterol levels.

"The American Diabetes Association guidelines recommend statin therapy for anyone who has both diabetes and cardiovascular disease, regardless of cholesterol levels," Selyukh wrote. "They also recommend statins for anyone older than 40 with diabetes and with cardiovascular disease risk factors, such as high blood pressure."

However, according to the Associated Press (AP), scientists from the pharmaceutical manufacturer believe that as many as 4 million diabetes patients over the age of 40 are ignoring that suggestion.

"Perhaps one third of the nation's eligible patients with type 2 diabetes are not being treated with a statin, so here's a convenient tool for doctors to target glucose as well as cholesterol levels," Dr. Sethu Reddy, Merck's director of clinical affairs for diabetes, told the AP.

In a press release, FDA officials said that the fixed-dosed combination (FDC) was "based on substantial experience" with both of the component medications, as well as confidence in the single-tablet Juvisync's ability "to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately."

"This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet," Mary H. Parks, Director of the Division of Metabolism and Endocrinology Products in the FDA´s Center for Drug Evaluation and Research, said in a statement.

"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," she added.


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