Monday, October 10, 2011

You Got Your Januvia in My Zocor! (Introducing Juvisync)


written by Michael O’Leary


Precursor to Juvisync?
If you have type 2 diabetes and take several medications each day, FDA approval of a the first combination drug that both lowers blood sugar and cholesterol is good news.

Juvisync combines the active ingredients of Januvia (sitagliptin) and Zocor (simvastatin).

“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, (Link to published site)
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.” 

According to the FDA, Juvisync is initially approved in a single dose containing 100 mg of sitagliptin and three doses of simvastatin in 10 mg, 20 mg, and 40 mg. Consequently only certain type 2 diabetes patients will be able to get a prescription for the drug. The FDA said in a press release that pending availability of the tablets containing 50 mg of sitagliptin, those needing a 50 mg dose of sitagliptin should continue to use the single ingredient drugs.

Juvisync is made by Merck subsidiary MSD International GmbH Clonmel of Tipperary, Ireland, which has committed to developing Juvisync in a 50 mg dose of sitagliptin and a variety of dosing levels for simvastatin that will be right for a wide variety of patients with type 2 diabetes and high cholesterol.
Simvastatin is currently marketed in dose strengths of 5, 10, 20, 40, and 80 mg. Due to recent restrictions placed on the use of the 80 mg dose because of a higher risk of muscle toxicity, there will not be a combination drug using the 80 mg dose. There is also no plan to develop a combination drug with the simvastatin 5 mg dose as few people are prescribed this dose.

Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body’s own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Simvastatin blocks an enzyme involved in the production of cholesterol and is approved for use with diet and exercise to reduce the amount of LDL cholesterol or “bad cholesterol” in the blood.

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. The FDA has recently become aware of the potential for statins to increase blood sugar levels in patients with type 2 diabetes. However, they say the risk appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes. The prescribing information for Juvisync will inform doctors of this possible side effect. The company will also be required to conduct an after-marketing clinical trial comparing the glucose lowering ability of sitagliptin alone compared to sitagliptin given with simvastatin.

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