(RxWiki News) The FDA has approved Juvisync, a prescription medication that contains two previously approved medicines in one tablet: Januvia (sitagliptin) for diabetes and Zocor (simvastatin) for high cholesterol.
About 20 million people in the U.S. have type 2 diabetes and often have high cholesterol levels as well. These conditions can increase one's risk of heart disease, stroke, kidney disease and blindness, among other chronic conditions.
"Patients can now treat diabetes and high cholesterol with one pill."
Januvia enhances the body's own ability to lower high levels of blood sugar and is used with diet and exercise by patients with type 2 diabetes to improve their control over their blood sugar. Like Januvia, Zocor is used with diet and exercise to reduce the amount of "bad cholesterol" (low-density lipoprotein cholesterol or LDL-C) in the blood.
Because each patient has different needs when it comes to controlling his or her diabetes and high cholesterol, different doses of the newly approved drug have been developed in fixed-dose combinations "to ensure safe and effective use of this product," explains Mary H. Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research.
The FDA's approval is based on substantial experience with both Zocor and Januvia and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when they are taken separately.
Juvisync was approved in dosage strengths for Januvia/Zocor of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. MSD International, which manufactures the medication, has committed to developing tablets of 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg.
The FDA has recently become aware of the potential for statins such as Zocor to increase blood sugar levels in patients with type 2 diabetes. This risk appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes patients. However, the prescribing information for Juvisync informs doctors and patients of this possible side effect.
The most common side effects of Juvisync include upper respiratory infection, stuffy or runny nose and sore throat, headache, muscle and stomach pain, constipation and nausea.