Known as Juvisync (Merck), the new medication combines sitagliptin (Januvia, Merck), a dipeptidyl peptidase-4 (DPP-4) inhibitor used for glycemia control, with the cholesterol-lowering simvastatin.…
Currently, the combination tablet is approved in three doses: sitagliptin/simvastatin 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg. Merck has told the FDA that it is planning on developing the fixed-dose combination tablet using sitagliptin 50 mg, making the sitagliptin/simvastatin combination available in 50-mg/10-mg, 50-mg/20-mg and 50-mg/40-mg doses.
Due to restrictions on using simvastatin 80 mg in patients because of concerns about muscle toxicity, the combination will not be available with high-dose simvastatin.
In a statement issued by the FDA, the new fixed-dose combination is approved given evidence that shows the drugs are effective when taken together as single tablets. “Juvisync is a convenience combination and should only be prescribed when it is appropriate for a patient to be placed on both of these drugs,” states the agency.
The FDA noted that statins can sometimes cause hyperglycemia in some patients with type 2 diabetes, although the risk is small and is outweighed by the cardiovascular disease risk reduction with the drugs. The prescribing information will contain a warning about this possibility. Common side effects with the combination include upper respiratory infections, rhinitis, sore throat, headache, muscle and stomach pain, constipation, and nausea, according to the FDA.
Merck, the maker of Juvisync, is required by the FDA to conduct a postmarketing study comparing the glucose-lowering ability of the sitagliptin/simvastatin combination with sitagliptin alone. Sitagliptin was approved in 2006 as adjunct to diet and exercise in patients with diabetes, while simvastatin is currently off patent in the US.
FDA Press Release, Oct, 7, 2011