The FDA today announced approval of a fixed-dose
combination therapy containing sitagliptin and simvastatin for the treatment of
adults with type 2 diabetes and high cholesterol.
“This is the first product to combine a type 2
diabetes drug with a cholesterol-lowering drug in one tablet,” Mary H.
Park, MD, director of the division of metabolism and endocrinology products
in the FDA Center for Drug Evaluation and Research, said in a
press release. “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 combination tablet (Juvisync; Merck) was approved in
sitagliptin/simvastatin dosage strengths of 100 mg/10 mg, 100 mg/20 mg and 100
mg/40 mg. According to the FDA, treatment should only be prescribed when
patients require treatment with both sitagliptin (Januvia, Merck) and
simvastatin (Zocor, Merck).