Skip to content
My WebMD Sign In, Sign Up

Diabetes Health Center

Font Size
A
A
A

Avandia Study Spurs New Heart Risk Debate

Diabetes Drug Doesn't Raise Risk of Death From Heart Disease, Shows Study; Critics Find Flaws
By
WebMD Health News
Reviewed by Louise Chang, MD

avandia_redux.jpg

June 5, 2009 -- A company-sponsored clinical trial shows that the diabetes drug Avandia causes no more heart deaths than standard treatment, but critics say the study is flawed.

Avandia, made by GlaxoSmithKline, is an oral drug that makes the body more sensitive to insulin.

But concerns that Avandia causes heart problems has led the American Diabetes Association's treatment guidelines committee to advise against prescribing Avandia in favor of Actos, another drug in the same class with fewer heart-safety concerns -- although both drugs increase a patient's risk of heart failure.

GlaxoSmithKline's RECORD study was supposed to answer these concerns. And according to study leader Philip D. Home, DPhil, of the U.K.'s Newcastle University, it did. Home presented the study findings at this week's meeting of the American Diabetes Association in New Orleans.

"The findings are essentially that in overall cardiovascular terms the drug is safe," Home said at a news conference. "There is no increased or decreased risk of death from heart disease, and that includes the heart failure data."

David Nathan, MD, chairman of the American Diabetes Association guideline committee, said the group would reconsider its recommendations in light of the study findings.

However, the study was unable to determine whether Avandia increases a patient's risk of heart attack. That concern was raised by several experts, including Steven Nissen, MD, chairman of cardiovascular medicine at the Cleveland Clinic.

Nissen remains unconvinced by the final report from Home and colleagues.

"The RECORD trial is seriously flawed," Nissen tells WebMD. "The authors don't reveal the number of patients who were still taking Avandia by the end of the study, but I would estimate this number to approach 50%. Obviously, it is impossible to assess the safety of a drug when patients are not actually taking it."

Home says patients assigned to Avandia treatment took the drug for 88% of the study time. But Nissen says Home's own previously published interim findings do not support this calculation.

Indeed, Home agrees that the study does not answer the question of whether patients taking Avandia have an increased risk of heart attack.

"But what we do know is that this is not associated with cardiovascular death," he said. "There were actually fewer deaths in the [Avandia] group."

In the study, all patients received standard treatment with metformin and/or a sulfonylurea. Half added Avandia to this treatment. The study was not blinded, meaning that study investigators and patients knew which treatment they were getting.

Nissen doubts that this unblinded study will convince experts to change their minds about Avandia. That, he says, will happen only if a new study -- the just-started TIDE study -- shows Avandia is truly safe. The TIDE study is a double-blind trial. And even though it is sponsored by GlaxoSmithKline, there will be a direct comparison of Avandia to Actos, made by Takeda Pharmaceuticals.

Is This Normal? Get the Facts Fast!

Check Your Blood Sugar Level Now
What type of diabetes do you have?
Your gender:

Get the latest Diabetes newsletter delivered to your inbox!


or
Answer:
Low
0-69
Normal
70-130
High
131+

Your level is currently

If the level is below 70 and you are experiencing symptoms such as shaking, sweating or difficulty thinking, you will need to raise the number immediately. A quick solution is to eat a few pieces of hard candy or 1 tablespoon of sugar or honey. Recheck your numbers again in 15 minutes to see if the number has gone up. If not, repeat the steps above or call your doctor.

People who experience hypoglycemia several times in a week should call their health care provider. It's important to monitor your levels each day so you can make sure your numbers are within the range. If you are pregnant always consult with your health care provider.

Congratulations on taking steps to manage your health.

However, it's important to continue to track your numbers so that you can make lifestyle changes if needed. If you are pregnant always consult with your physician.

Your level is high if this reading was taken before eating. Aim for 70-130 before meals and less than 180 two hours after meals.

Even if your number is high, it's not too late for you to take control of your health and lower your blood sugar.

One of the first steps is to monitor your levels each day. If you are pregnant always consult with your physician.

Did You Know Your Lifestyle Choices
Affect Your Blood Sugar?

Use the Blood Glucose Tracker to monitor
how well you manage your blood sugar over time.

Get Started

This tool is not intended for women who are pregnant.

Start Over

Step:  of 

Today on WebMD

Woman holding cake
Slideshow
feet
Slideshow
 
man organizing pills
Slideshow
Close up of eye
Slideshow
 

Woman serving fast food from window
Video
Can Vinegar Treat Diabetes
Video
 
Middle aged person
Tool
are battery operated toothbrushes really better
Video
 

Prediabetes How to Prevent Type 2 Diabetes
Article
type 2 diabetes
Slideshow
 
food fitness planner
Tool
Are You at Risk for Dupuytrens Contracture
Article
 

WebMD Special Sections