FDA approves sitagliptin and simvastatin combination therapy

October 7, 2011

FDA has approved sitagliptin and simvastatin (Juvisync, MSD International GmbH Clonmel), a fixed-dose combination prescription medication that contains 2 previously approved medications in 1 tablet for use by adults who need both sitagliptin and simvastatin.

FDA has approved sitagliptin and simvastatin (Juvisync, MSD International GmbH Clonmel), a fixed-dose combination (FDC) prescription medication that contains 2 previously approved medications in 1 tablet for use by adults who need both sitagliptin and simvastatin.

About 20 million people in the United States have type 2 diabetes, and they often have high cholesterol levels as well. These conditions can lead to increased risk of heart disease, stroke, kidney disease, and blindness, among other chronic conditions, particularly if left untreated or poorly treated.

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 glycemic control in adults with type 2 diabetes. Simvastatin is an HMG-CoA reductase inhibitor, or statin, approved for use with diet and exercise to reduce the amount of "bad cholesterol" (low-density lipoprotein cholesterol or LDL-C) in the blood.

"This is the first product to combine a type 2 diabetes drug with a cholesterol-lowering drug in 1 tablet," said Mary H. Parks, MD, director of the Division of Metabolism and Endocrinology Products in 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."

This FDC is based on substantial experience with both sitagliptin and simvastatin, as well as with the capacity of the single tablet to deliver similar amounts of the drugs to the bloodstream, as when sitagliptin and simvastatin are taken separately. Juvisync is a convenience combination and should be prescribed only when it is appropriate for a patient to be placed on both of these drugs.

Juvisync was approved in dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg. The company has committed to developing FDC tablets with the sitagliptin 50-mg dose, as Juvisync 50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg. Pending availability of the FDC tablets containing 50 mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet. There is no plan to develop FDCs with the sitagliptin 25-mg dose, as use of this dosage is quite limited.

Simvastatin is currently marketed in dosage 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 an FDC using this dose. There is also no plan to develop FDCs with the simvastatin 5-mg dose, as use of this dosage is quite limited, as well.

FDA recently became aware of the potential for statins 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. However, the prescribing information for the sitagliptin/simvastatin combination will inform doctors of this possible side effect. The company will also be required to conduct a post-marketing clinical trial comparing the glucose-lowering capacity of sitagliptin alone to sitagliptin given with simvastatin.

The sitagliptin/simvastatin combination is approved with a Medication Guide that provides important information to patients. The most common side effects of the sitagliptin/simvastatin combination include upper respiratory infection, stuffy or runny nose and sore throat, headache, muscle and stomach pain, constipation, and nausea.