Diabetes-Cholesterol Combo Drug Approved by FDA
The first medication to treat both type 2 diabetes and high cholesterol has received Food and Drug Administration approval.
The drug, Juvisync, is a combination of the diabetes medication Januvia (sitagliptin) and the cholesterol-lowering statin Zocor (simvastatin). The convenience of a single pill isn't Juvisync's only selling point: The combination pill will sell for the same price as Januvia.
According to the manufacturer, Merck, plans are in the works for the drug's release "in the near future." The medication was approved in three dosage strengths—100 mg of Januvia and either 10, 20, or 40 mg of Zocor—though the company, at the FDA's urging, will also develop doses with the same amount of Zocor and only 50 mg of Januvia.
The FDA said that while statins like Zocor have the potential to raise blood glucose levels in people with type 2 diabetes, the drugs' ability to reduce the likelihood of heart disease outweighed the small risk. Other possible side effects of Juvisync include headache, sore throat, stomach pain, and upper respiratory infections, such as a cold or sinus infection.
The significance of the FDA's October 7 approval of Juvisync is potentially huge: More than 20 million people in the United States have type 2 diabetes, and they're two to four times as likely to die from heart disease as adults without the disease. High LDL ("bad") cholesterol is a cause of heart disease.
"Although clinical guidelines put people with type 2 diabetes who need glycemic and lipid therapy at the same risk level as those with coronary heart disease," said Barry J. Goldstein, MD, PhD, vice president of diabetes and endocrinology at Merck, in a statement, "nearly 40 percent of eligible patients do not receive statin treatment."