FDA OKays combo pill for diabetes, cholesterol

The FDA has approved a fixed-dose combination tablet that combines the diabetes drug sitagliptin with simvastatin, under the brand name Juvisync. It's the first product with drugs for diabetes and high cholesterol in a single pill, the agency noted. Sitagliptin is a DPP-4 inhibitor sold as Januvia, first approved in 2006 as an adjunct to diet and exercise. Simvastatin (Zocor) is one of the most popular statin drugs for reducing total and LDL cholesterol. In the short term, the combination product will come in three strengths, all with 100 mg of sitagliptin and 10, 20, or 40 mg of simvstatin. The FDA advised physicians to consider other drugs that patients may be taking when deciding which strength to prescribe. The product's manufacturer, the Merck subsidiary MSD International GmbH Clonmel, of Tipperary, Ireland, has committed to develop additional strengths with 50 mg of sitagliptin and 10, 20, and 40 mg of simvastatin, according to the agency. "Pending availability of the fixed-dose combination tablets containing 50 mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet," the FDA said. Sitagliptin is also sold in a 25-mg dose, but it is seldom prescribed and there are no plans to develop Juvisync tablets with that dose, the agency added. The FDA noted that statins can exacerbate hyperglycemia 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," the agency said. "However, the prescribing information for Juvisync 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 ability of sitagliptin alone compared to sitagliptin given with simvastatin." Common side effects associated with the combination include upper respiratory infections, rhinitis, sore throat, headache, muscle and stomach pain, constipation, and nausea. (You may wish to consult your own medical expert about this)