The first single tablet for both diabetes type 2 and high cholesterol, Juvisync (sitagliptin and simvastatin), has been approved by the FDA (Food and Drug Administration). Sitagliptin and simvastatin are previously approved medications to separately treat elevated sugar and high cholesterol respectively. The new tablet, Juvisync, is an FDC (fixed-dose combination) of the two medications.

Approximately 20 million individuals in America have diabetes type 2. A high proportion of them also suffer from high cholesterol levels. High cholesterol can lead to kidney disease, blindness, heart disease, and stroke, especially if the condition is poorly controlled.

Sitagliptin is already approved, in combination with exercise and diet to improve glycemic control in diabetes type 2 adults. It is a dipeptidyl peptidase 4 (DPP-4) inhibitor, it improves the patient’s body’s ability to lower high blood sugar levels.

Simvastatin is a cholesterol-lowering drug, a statin. It specifically lowers LDL-C, known as low-density lipoprotein cholesterol, also known as “bad cholesterol. Simvastatin is an HMG-CoA reductase inhibitor.

Mary H. Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said:

“This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet. 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 FDA informs that this fixed-dose combination is based on considerable experience with both simvastatin and sitagliptin, and the ability of the single tablet to deliver similar drug doses into the bloodstream as when the separate active ingredients are taken separately.

The Agency stressed on its website that Juvisync should only be prescribed to patients who are suitable for both medications simultaneously.

The FDA has approved Juvisync tablets in the following sitagliptin/simvastatin dosages – 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. The FDA added “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 dose is quite low.”

Simvastatin is currently available in 5, 10, 20, 40 and 80 mg dosage strengths. There will be no fixed-dose combinations with 80mg simvastatin because of muscle toxicity risk, the FDA informs. There is no plan for a 5 mg simvastatin content in the combination tablet either.

There is a potential for statins to raise blood glucose levels in people with diabetes type 2. However, the FDA says it is a small risk, which is outweighed by the benefits in reducing heart disease among patients with diabetes.

Doctors will be informed of the small risk associated with Juvisync in the prescribing information. The company (MSD International) will have to carry out a post-marketing clinical trial comparing sitagliptin’s glucose lowering ability on its own and when combined with simvastatin.

Juvisync’s most common side effects include runny nose, stuffy nose, sore throat, headache, constipation, nausea, stomach pain, and upper respiratory infection.

Juvisync is manufactured by MSD International GmbH Clonmel, Co. in Tipperary, Ireland.

Written by Christian Nordqvist