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:5/26/2016)... ... 2016 , ... OncLive® , a leading digital provider ... University of Virginia (UVA) Cancer Center to its quickly expanding Strategic ... will publicize and promote public awareness of UVA Cancer Center’s latest advances in ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... ... organization to provide strategic sales leadership and to further develop their rapidly expanding ... B.S. in Business Administration with a concentration in Marketing and an M.B.A. with ...
(Date:5/26/2016)... ... ... Dr. LeRoy Perry’s recently authored whitepaper, “Tech Neck and ROI (return on ... users, hundreds of millions of whom are coming into the workplace with pain in ... action of looking down at hand-held technology devices (tablets, smartphones) for extended periods of ...
(Date:5/26/2016)... ... , ... In 1980, Bill Howe opened AM/PM Sewer and Drains as a ... to grow the company was built on a simple mission of providing qualified San ... and customer service. Over 35 years later, Bill Howe remains one of the largest ...
(Date:5/26/2016)... ... May 26, 2016 , ... TopConsumerReviews.com ... Blood Pressure products . , High blood pressure affects millions of people worldwide, ... blood pressure can lead to heart disease, stroke, kidney disease, and hardening of ...
Breaking Medicine News(10 mins):
(Date:5/26/2016)... According to a new market report ... U.S. Industry Analysis, Size, Share, Growth, Trends, and Forecast 2015 ... was valued at US$ 5.89 Bn in 2014 and is ... to 2023 to reach US$ 7.99 Bn in 2023. ... needle free drug delivery devices and the market is estimated ...
(Date:5/26/2016)... A key trend that will ... of new treatments. Cardax, a development stage life sciences ... therapy is expected to fulfil large unmet medical needs ... studies to develop new treatments for osteoarthritis. One such ... in osteoarthritis are being investigated, and early trials of ...
(Date:5/26/2016)... 2016 TARE (Transarterial Radio-embolization) ... Savings and Overall Decreased Use of Hospital ... international specialist healthcare company, has today announced the ... Meeting of ISPOR (International Society for Pharmacoeconomics and ... (HCC) using yttrium-90 glass microspheres is associated with ...
Breaking Medicine Technology: