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Sitagliptin/Simvastatin Combo Tablet for T2DM and Hypercholesterolemia

Sitagliptin/Simvastatin (Juvisync) might be a good option for diabetic patients who want to improve glycemic control and lower cholesterol levels…

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Juvisync, a combination tablet of sitagliptin and simvastatin, was approved by the US Food and Drug Administration (FDA) in October 2011, and is now manufactured by MSD International GmbH for Merck and Co. This medication provides HbA1C lowering effects and cardiovascular benefits, which are necessary for patients with diabetes and hypercholesterolemia. This study’s goal was to review the medication profile for each drug separately and in combination.

PubMed was searched during the year from 2001 to 2014 for all primary and review articles, meta-analysis, and case reports involving the safety and efficacy outcomes for each of the drugs individually and the combination. Guidelines for diabetes and hypercholesterolemia as well as manufacturing data and product labeling were also used. There was no clinical trial that compares Juvisync with each individual ingredient sitagliptin and simvastatin. Search limits included English language trials and only human subjects.

Sitagliptin was shown to decrease HbA1C level from baseline in diabetic patients who were not controlled on glimepiride alone or in combination with metformin. However, it had a slightly higher risk of hypoglycemia and weight gain. In another study, sitagliptin was noninferior to combination of glipizide and metformin, and had lower rates of hypoglycemia and weight gain. In addition, when comparing with insulin glargine in patients not controlled on metformin, sitagliptin was less effective in reducing HbA1C level; however, it was associated with less hypoglycemic events. Simvastatin was also shown to have positive cardiovascular effects in patients with diabetes regardless of baseline lipid levels or existing cardiac disease. Side effect profiles for both medications were acceptable. However, Juvisync is contraindicated for coadministration with gemfibrozil, cyclosporine, danazol, or any strong cytochrome P450 3A4 inhibitor due to the risk of myopathy and rhabdomyolysis as they can increase simvastatin levels. Safety and efficacy profiles for Juvisync have not been established in patients less than 18 years of age. Geriatric population, pregnancy/lactation population, and patients with renal/hepatic impairment are either not recommended or contraindicated.

Juvisync is indicated for patients who require the use of both agents, sitagliptin and simvastatin. Since sitagliptin was noninferior to combination of glipizide and metformin, and had lower rates of hypoglycemia and weight gain. Low rates of hypoglycemia were also confirmed in a study with insulin glargine. Thus, sitagliptin is a good option for diabetic patients to lower blood glucose level while having lower risk of hypoglycemia and weight gain. Efficacy and side effect profile were acceptable, however, caution must be taken in combination with certain medications to avoid the risks of myopathy and rhabdomyolysis.

Practice Pearls:

  • Juvisync comes in 100mg/10mg, 100mg/20mg, and 100mg/40mg (starting dose) once daily in the evening. It should not be split, crushed, or chewed before swallowing.
  • If Juvisync is used as an adjunct to insulin secretagogue or insulin, the dose of the latter should be reduced due to the risk of hypoglycemia.
  • The cost of Juvisync will be the same as the price of Januvia (sitagliptin) alone, or $216/month. No generic will be available until April 2017.

Wijdan H Ramadan, Wissam K Kabbara. "Sitagliptin/Simvastatin: a first combination tablet to treat type 2 diabetes and hypercholesterolemia – a review of its characteristics." Vascular Health and Risk Management February 2015:11.