Navigation Links
Avandia May Slow Atherosclerosis After Bypass Surgery

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:
(Date:11/27/2015)... ... , ... A simply groundbreaking television series, "Voices in America", which is hosted ... array of issues that are presently affecting Americans. Dedicated to providing the world with ... changing the subjects consumers focus on, one episode at a time. , In ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... successful and prominent nonprofit healthcare organizations in the country. They have overseen financial ... organizations, and helped advance the healthcare industry as a whole through their advocacy ...
(Date:11/26/2015)... ... November 26, 2015 , ... Patients at Serenity Point ... come together on Thanksgiving Day to share the things that they are most ... Serenity Point YouTube channel, patients displayed what they wrote on index cards, describing ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... to discuss bioavailability and the need to integrate dose form selection in early ... with OBN, the membership organization supporting and bringing together the UK’s emerging life ...
(Date:11/26/2015)... ... November 26, 2015 , ... Pixel ... self-animating trailer titles with ProTrailer: Vintage. This newly styled ProTrailer pack comes with ... work with any font, giving users limitless opportunities to stylize and create designs ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 26, 2015 Research and Markets ( ) ... Pacemaker Market Outlook to 2019 - Rise in Cardiac Disorders ... report to their offering. Boston ... Boston scientific and others. --> ... Biotronik, Boston scientific and others. ...
(Date:11/26/2015)... 26, 2015 ... "2016 Future Horizons and Growth Strategies ... Market: Supplier Shares, Country Segment Forecasts, Competitive ... offering. --> ) has ... Future Horizons and Growth Strategies in the ...
(Date:11/26/2015)... 2015 ) has ... of High Viscosity Drugs" report to their ... the addition of the "Self Administration of ... --> Research and Markets ( ... "Self Administration of High Viscosity Drugs" report ...
Breaking Medicine Technology: