Crouse Health Online: Wellness is just a click away.
Share Share
  |  Connect with Us: 
large
med
small
Text Size
 

Health News



FDA Approves First Combo Drug for Diabetes, Cholesterol

FDA Approves First Combo Drug for Diabetes, Cholesterol

10/07/11

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 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.

Copyright © 2011 HealthDay. All rights reserved.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

OF INTEREST:
 

Latest News

Crouse Hospital First in Region to Use New da Vinci Xi Surgical System
more >

MedEx Bedside Prescription Delivery Service

Free service offers convenience, patient education at discharge.
more >

CrouseSports Express After-Hours Ortho Care

Immediate care of orthopedic injuries in kids and adults.
more >

Weight Loss Surgery

Is it right for you? Attend a free information seminar held twice monthly.
more >

Quality at Crouse

See how Crouse Hospital strives to provide the best in patient care.
more >

Cheer Up That Special Someone

Say get well or welcome a new arrival with a gift purchased right at Crouse.

more >

Make an Online Donation Now

Your donation of any amount helps support Crouse services & programs in a meaningful way.
more >

Shop Online Now

Say get well, thinking of you or welcome new baby with a unique gift from the Crouse Gift Shop.

more >