FDA OKs Pill for Diabetes and High Cholesterol

Oct. 7, 2011 -- The FDA has approved the first combination pill for treating both type 2 diabetes and high cholesterol.

Juvisync, made by Merck, combines the drugmaker's diabetes pill Januvia (sitagliptin) with its popular cholesterol drug Zocor (simvastatin).

About 20 million people in the U.S. have type 2 diabetes. Many of those patients also have high cholesterol.

These conditions increase the risk of heart disease, stroke, kidney disease, and blindness.

Combination Drug

Januvia enhances the body's ability to lower high blood sugar and is approved to fight type 2 diabetes in combination with diet and exercise.

Zocor is approved to reduce LDL "bad" cholesterol levels in combination with diet and exercise.

"This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet," says the FDA's Mary H. Parks, MD, in a news release. "However, to ensure safe and effective use of this product, tablets containing different doses of [Januvia] and [Zocor] 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."

Juvisync will be available in several different dosage strengths to accommodate the needs of patients with varying levels of cholesterol and blood sugar.

Side Effects

The FDA says it recently has become aware of the potential for statins to increase blood sugar levels in patients with type 2 diabetes. However, this risk is outweighed by the benefits of the combo pill in reducing heart disease, according to FDA. Prescribing information for Juvisync will educate doctors about this possible side effect.

The most common side effects of Juvisync include upper respiratory infection, stuffy or runny nose, sore throat, headache, muscle and stomach pain, constipation, and nausea.