On May 21, 2007, a study published by Dr. Steve Nissen in the New England Journal of Medicine alleged there is an increased risk of cardiovascular disease associated with the diabetes drug Avandia. The following are some questions and answers relating to the new study:

1. Who is Dr. Steve Nissen?

Steve Nissen is a cardiologist and chairman of cardiovascular medicine for the Cleveland Clinic, one of the most prestigious heart clinics in the United States. In 2001, he co-authored an analysis of Vioxx that found an increased risk of heart attack or stroke in patients. Merck recalled the drug in September 2004 after its own study confirmed the risk. Dr. Nissen also published an article in 2005 speaking about concerns he had with Pargluva, a diabetes drug that a Food and Drug Administration (FDA) panel supported. The FDA ultimately declined to approve the drug.

After his Pargluva study, Dr. Nissen received an email from a diabetes expert who suggested that Avandia undergo analysis as well. He began studying Avandia in 2006, initiating congressional investigations and researching previous studies published by GlaxoSmithKline. While researching, he found a study similar to the one he was conducting performed by GlaxoSmithKline. The study also showed slightly elevated risks of heart attacks, but the company wrote that these risks were manageable and no conclusion could be drawn from their study.

Dr. Nissen found, after conducting a meta-analysis of 42 previous studies, that Avandia shows a higher heart-attack risk, and a 64 percent elevated risk of death from cardiovascular causes like a heart attack or stroke.

2. GlaxoSmithKline performed a previous study of Avandia and said results were inconclusive. Do they agree with this new study?

GlaxoSmithKline has said it “strongly disagrees” with Dr. Nissen’s conclusions and assures its patients that it has full confidence in the safety of Avandia when used appropriately.

3. What is a meta analysis?

A meta analysis is a study that combines results from a group of previous studies that examine the same question. The purpose is to summarize all possible evidence relating to a specific issue or drug.

4. Should I stop taking Avandia?

A patient should never stop taking medication without first discussing it with a doctor. The FDA has advised patients taking Avandia to discuss cardiovascular risks with their doctors and to consider alternative therapies. In a joint statement with the FDA, the American Heart Association, American College of Cardiology, and American Diabetes Association said the overall risk associated with Avandia “appears to be small.”

5. I’m a diabetic. Should I be concerned about Dr. Nissen’s results?

If a diabetes patient is already taking a heart medication, the risk for a cardiovascular problem may be especially high. Cardiovascular disease is the leading cause of death in patients with diabetes and affects people with diabetes more than twice as often as other patients.

Patients taking Avandia are advised to speak with their doctors about the new drug information and about available treatment options.

6. When should I see my doctor?

Avandia may cause your body to hold extra fluid, which can lead to swelling and weight gain. The extra body fluid may cause some heart problems to worsen or may lead to heart failure. If you have any of the following symptoms, you should call your doctor immediately:

• Swelling or fluid retention
• Shortness of breath or trouble breathing
• An unusually rapid increase in weight
• Unusual tiredness
• Unexplained tiredness
• Stomach problems
• Dark urine
• Yellowing of skin
• Vision changes (rare)

7. Where can I find more information about Avandia?

For more information, consumers can visit GlaxoSmithKline’s Avandia website, or call GlaxoSmithKline’s Customer Response Center at 1-888-825-5249 between 8 a.m. and 8 p.m. Monday through Friday.

Sources: Anna Wilde Matthews, “Sequel for Vioxx critic: Attack on diabetes pill,” Wall Street Journal, May 22, 2007; Sarah Rubenstein, “What diabetes patients need to know,” Wall Street Journal, May 22, 2007; Food and Drug Administration Release P07-88, May 21, 2007; American Diabetes Association joint statement, May 21, 2007; GlaxoSmithKline, “Questions and Answers to Current Events about Avandia,” May 21, 2007.