Navigation Links
Avandia May Slow Atherosclerosis After Bypass Surgery
Date:4/1/2008

But this new study of diabetes drug doesn't prove it's safe, critics say

TUESDAY, April 1 (HealthDay News) -- The controversial diabetes drug Avandia appears to slow the progression of atherosclerosis in diabetic patients who have undergone cardiac bypass surgery, thus protecting them from new cardiac problems, according to the results of a small study.

Avandia (rosiglitazone) has been associated with increased risk of heart attack and heart failure among patients receiving the drug. In November, the U.S. Food and Drug Administration, while calling the evidence for heart attack inconclusive, agreed to keep the drug on the market, but with a black box warning about the heart attack risk.

In the new study, which included almost 100 patients taking Avandia, the study authors said they found the drug was safe and had no more cardiovascular risks than a placebo.

The VICTORY (Vein Coronary Atherosclerosis and Rosiglitazone After Bypass Surgery) study included 193 patients with type 2 diabetes who had undergone cardiac bypass surgery. They were randomly assigned to receive Avandia or a placebo. The trial was paid for by GlaxoSmithKline, the maker of Avandia.

The researchers found that after one year, patients taking Avandia had better blood sugar control, compared with those on a placebo. In addition, patients taking Avandia showed improved cholesterol levels, fewer signs of inflammation of blood vessels, and lower blood pressure than those patients taking a dummy pill.

Also, there was no significant difference in cardiovascular events between the two groups, the researchers noted.

"The enrollment of high-risk cardiovascular patients with type 2 diabetes in a placebo-controlled trial with rosiglitazone was found to have an acceptable safety profile," the researchers concluded.

The findings were presented Tuesday at the American College of Cardiology annual meeting, in Chicago. The presenter was Dr. Olivier F. Bertrand, assistant professor at Laval University in Quebec City, Canada.

Despite the study findings, one heart expert said the results were insignificant and didn't really show that Avandia was safe.

"How exactly can they establish the safety of rosiglitazone in a short-term study with less than 100 patients receiving the drug?" asked Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation, who was the first to report the risk of heart attack associated with Avandia. "This was an intravascular ultrasound study, not a morbidity-mortality study."

Dr. Gregg C. Fonarow, a professor of cardiology at the University of California, Los Angeles, agreed with Nissen that the study was too small to make any valid claims about the safety of Avandia.

"This study with only 193 patients is too small to draw any conclusions regarding the potential benefits and risk of rosiglitazone in this patient population," he said.

Dr. Paul Aftring, senior director of metabolic research at GlaxoSmithKline, said, "We recognize the limitation of the size of this study, but the safety data were very reassuring. They are consistent with other data in high-risk populations."

The safety data of any trial is never defined by a population of less than 100 patients, Aftring said. "But the longer-term data in longer-term studies in high-risk populations is actually quite reassuring," he added.

Aftring noted that the current labeling of Avandia says that the drug should be used with caution in high-risk populations. "Victory adds to the knowledge base that in well-managed populations, careful use of rosiglitazone is appropriate, and there are no safety issues," he said.

More information

For more on diabetes drugs, visit the U.S. Food and Drug Administration .



SOURCES: Steven Nissen, M.D., chairman, department of cardiovascular medicine, Cleveland Clinic Foundation, Ohio; Gregg C. Fonarow, M.D., professor, cardiology, University of California, Los Angeles; April 2008, presentation, American College of Cardiologys 57th annual meeting, Chicago; April 1, 2008, prepared statement, GlaxoSmithKline


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Diabetes Drug Avandia Boosts Heart Risks: Study
2. GSK Revises US Labeling for Avandia(R)
3. Avandia Label to Get Heart-Attack Warning
4. Diabetes Drug Avandia Could Weaken Bones
5. Safety Concerns Prompt Prime to Remove Avandia(R) from Formulary
6. Older Diabetics Using Avandia Face Increased Death Risk
7. CRESTOR(R) Now Indicated to Slow the Progression of Atherosclerosis in Patients With Elevated Cholesterol
8. Atherosclerosis solution is likely many years away
9. New potential drug target for the treatment of atherosclerosis
10. Study in Circulation Research details how diabetes drives atherosclerosis
11. Genes that protect against atherosclerosis identified
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... Today, the ... , announced that the much-anticipated feature with author Jahnavi Foster, specialist in healthy vegetarian ... TV Network. , Each week, on his weekly Whole-Food Warrior TV show, Frank Davis ...
(Date:2/5/2016)... ... February 05, 2016 , ... Francisco Canales, MD ... in their Napa Valley office. The technique utilizes the body’s own healing abilities ... and Dr. Furnas, are part of only a select few cosmetic surgeons bringing ...
(Date:2/5/2016)... ... February 05, 2016 , ... The Lymphoma ... innovative lymphoma research and serving the lymphoma community through a comprehensive series of ... host, Swirl, A Wine Tasting Event at the La Gorce Country Club in ...
(Date:2/5/2016)... ... 2016 , ... Regular gym users know the routine: each January, they see ... the treadmills. It’s a predictable trend. After the excesses of November and December, people ... by joining gyms, starting new walking or running routines, or signing up for Zumba. ...
(Date:2/5/2016)... ... February 05, 2016 , ... At its annual meeting held ... as Chairman of the National Board of Directors. Mr. McDermott succeeds former APDA Chairman, ... stated Leslie A. Chambers , APDA President and CEO. “Pat has tirelessly served ...
Breaking Medicine News(10 mins):
(Date:2/5/2016)... 5, 2016 Amgen (NASDAQ: AMGN ) will ... Healthcare Conference at 9:15 a.m. ET on Wednesday, Feb. 10, ... David W. Meline , executive vice president and chief financial ... of the presentation can be accessed from the Events Calendar ... of the webcast will also be available on Amgen,s website ...
(Date:2/5/2016)... Feb. 5, 2016  ivWatch, a medical devices company, is ... Award granted by Governor Terry McAuliffe,s office. ivWatch ... February 25th at an event to be held at the ... award honors professionals and business that have made significant contributions ... Logo - http://photos.prnewswire.com/prnh/20160205/330117LOGO ...
(Date:2/5/2016)... , Feb. 5, 2016  Aralez Pharmaceuticals Inc. ("Aralez") ... POZEN Inc. ("POZEN") and Tribute Pharmaceuticals Canada Inc. ("Tribute") following ... shareholders of Tribute. The combined company will operate under ... with operations in Canada , ... States . Under the terms of the Agreement ...
Breaking Medicine Technology: