FDA Approves First Combo Drug for Diabetes, Cholesterol10/07/11
FRIDAY, Oct. 7 (HealthDay News) -- A first-of-a-kind pill that
treats both type 2 diabetes and high cholesterol was approved by
the U.S. Food and Drug Administration on Friday.
Juvisync is a prescription medication that contains two
previously approved medicines, sitagliptin (Januvia) and
simvastatin (Zocor). Sitagliptin helps lower blood sugar levels,
and simvastatin reduces the amount of "bad" low-density lipoprotein
in the blood.
Many of the estimated 20 million people in the United States
with type 2 diabetes also have high cholesterol, the FDA
researchers noted. The two conditions are associated with increased
risk of chronic conditions, such as heart disease, stroke, kidney
disease and blindness.
"This is the first product to combine a type 2 diabetes drug with a cholesterol-lowering drug in one tablet," Dr. Mary H. Parks, director of the division of metabolism and endocrinology products in the FDA's Center for Drug Evaluation and Research, said in the news release.
One expert said the two-in-one pill might be of help to some
"Certainly, as 20 million people are suffering with diabetes in this country, aggressive proactive prevention is critical," noted Dr. Suzanne Steinbaum, a preventive cardiologist at Lenox Hill Hospital in New York City. "Perhaps this is the first medication which can help successfully address these significant and pervasive risk factors."
The Juvisync dosage strengths approved by the FDA are 100
milligrams (mg) of sitagliptin with 10 mg, 20 mg or 40 mg of
simvastatin. The drug maker -- MSD International GmbH Clonmel, Co.
of Ireland -- has promised to develop Juvisync doses with 50 mg/10
mg, 50 mg/20 mg, and 50 mg/40 mg of sitagliptin/simvastatin,
according to an FDA news release.
Patients who require a 50-mg dose of sitagliptin should continue
to use single-ingredient sitagliptin tablets with that dose until
Juvisync with 50 mg of sitagliptin is available, the FDA said.
"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," Parks added.
The most common side effects of Juvisync include: upper
respiratory infection; stuffy or runny nose and sore throat;
headache, muscle and stomach pain; constipation; and nausea.
The U.S. Agency for Healthcare Research and Quality has more
medicines for type 2 diabetes.
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