FDA Approves First Combo Drug for ... - Health Nutrition and Fitness

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
patients.

?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.

More information

The U.S. Agency for Healthcare Research and Quality has more about medicines for type 2 diabetes.

Article source: http://news.yahoo.com/fda-approves-first-combo-drug-diabetes-cholesterol-182011071.html

Source: http://health-nutrition-fitness.net/medical-and-health-news/fda-approves-first-combo-drug-for-diabetes-cholesterol/

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