It’s over for rosiglitazone.
Sold in the U.S. as Avandia, rosiglitazone is a drug used to control type 2 diabetes either alone or in combination with insulin, metformin, or a sulfonylurea. It has only one competitor in its class: pioglitazone (sold as Actos).
Both drugs in the thiazolidinedione class (aka TZDs or glitazones) increase the risk of heart failure. Prior studies had suggested that rosiglitazone increases the risk of heart attack, heart failure, and death. Research suggested that pioglitazone actually reduces the risk of heart attack, stroke, and death.
A study just published in the Journal of the American Medical Association directly compared clinical use of rosiglitazone and pioglitazone. Investigators looked at Medicare data involving over 227,000 patients, average age 74, average follow-up of 105 days.
Rosiglitazone comes out the loser: users had significantly higher risk of stroke, heart failure, and death. Risk of heart attack trended a bit higher in the rosi users but did not reach statistical significance.
The researchers also calculated the composite risk of suffering either a heart attack, stroke, heart failure, or death: rosiglitazone risk was about 18% higher compared to pioglitazone.
What do these numbers mean from a practical viewpoint? The researchers calculated a “number needed to harm.” Treat 60 patients with rosi and 60 with pio for one year; the rosi group will have one extra event—heart attack, stroke, heart failure, or death—compared with the pio users.
Why put up with that risk? There’s no good reason. Especially when pioglitazone is available.
Implications
If you take rosiglitazone, ask your doctor to find an alternative or switch you to pioglitazone. Soon.
Clearly, we don’t know all of the adverse effects of many of the drugs doctors prescribe, whether for diabetes or other illnesses. We balance the good with the bad, and that equation changes over time.
Rosiglitazone’s manufacturer may pull the drug off the market voluntarily. If not, the FDA will do it. Cardiovascular disease—e.g., heart attacks, strokes, heart failure—kills 68% of diabetics. The last thing we need is a drug that increases that risk.
Within a month, you’ll see ads on U.S. television from trial lawyers asking if you or a loved one has been hurt by rosiglitazone. “If so, call this toll-free number now…”
Reference: Graham, D., Ouellet-Hellstrom, R., MaCurdy, T., Ali, F., Sholley, C., Worrall, C., & Kelman, J. (2010). Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone JAMA: The Journal of the American Medical Association DOI: 10.1001/jama.2010.920
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