Pharmacology Update

Sitagliptin and Simvastatin Tablets (Juvisync™)

By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD. Dr. Elliott is Chair, Formulary Committee, Northern California Kaiser Permanente; and Assistant Professor of Medicine, University of California, San Francisco. Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA. Drs. Elliott and Chan report no financial relationships relevant to this field of study.

The FDA has approved the first fixed-dose combination product for the treatment of type 2 diabetes and hypercholesterolemia. This tablet combines a dipeptidyl peptidase-4 inhibitor (sitagliptin) and a HMG-CoA reductase inhibitor (simvastatin). It is marketed by Merck & Co. as Juvisync™.

Indications

The fixed-dose combination of sitagliptin and simvastatin (SITA/SIMV) is indicated in patients for whom the treatment with both sitagliptin and simvastatin is appropriate.1

Dosage

The recommended starting dose is 100 mg/40 mg once daily taken in the evening. Patients currently on SIMV 10 mg, 20 mg, or 40 mg can initiate the same SIMV dose as a fixed-dose combination.

SITA/SIMV is available as 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg tablets.

Potential Advantages

SITA/SIMV provides a convenient single tablet fixed-dose combination for patients who have already been titrated to the optimal dose of sitagliptin and simvastatin.

Potential Disadvantages

As with any fixed-dose combination, there is lack of flexibility for dose titration of each component.

Comments

The approval of SITA/SIMV was based on clinical data of sitagliptin and simvastatin separately. The bioequivalence of the fixed-dose combination is the same as coadministration of each component as individual tablets. The action of sitagliptin, a DPP-4 inhibitor, results in reduction of fasting glucose and postprandial glucose excursion. As monotherapy in patients with type 2 diabetes, sitagliptin produced a placebo-adjusted decrease in HbA1c of 0.6% in 18 weeks and 0.8% at 24 weeks.1 Fasting plasma glucose showed a net decrease of 17 to 20 mg/dL and a decrease of 47 mg/dL postprandial plasma glucose. Simvastatin has been shown to reduce the risk of coronary heart disease mortality and cardiovascular events.1 Common adverse reactions include upper respiratory infections, headache, nasopharyngitis, abdominal pain, constipation, and nausea.

Clinical Implications

SITA/SIMV provides a fixed-dose combination of an effective drug for type 2 diabetes and hypercholesterolemia. This fixed-dose combination may be convenient for some patients. Cost compared to prescribing these separately would vary based on one’s drug benefit as simvastatin is available generically.

Reference

1. Juvisync Prescribing Information. Whitehouse Station, NJ: Merck & Co., Inc; October 2011.