Diabetes study shows nothing new, says journal editor

BMJ 2007; 335 doi: (Published 02 August 2007) Cite this as: BMJ 2007;335:223
  1. Janice Hopkins Tanne
  1. New York

    Vivian Fonseca, the editor of Diabetes Care, told the BMJ that he was surprised by the media's interest in a study that says that rosiglitazone (Avandia) and pioglitazone (Actos) doubled the risk of heart failure in patients with type 2 diabetes (Diabetes Care 2007;30:2148-53 doi: 10.2337/dc07-0141).

    The authors said that although drugs in the thiazolidinedione class were known to increase the risk of heart failure in patients with type 2 diabetes, the magnitude of the risk had not been evaluated. They used teleoanalysis to look at results from many different types of trials, involving 78 000 patients, and concluded that one in every 50 patients with type 2 diabetes taking one of these drugs would develop heart failure in a period of 26 months and need admission to hospital (see BMJ 2003;327:616-8 doi: 10.1136/bmj.327.7415.616 for an explanation of teleoanalysis).

    Heart failure occurred at low and high doses of the drugs and among people younger than 60 years as well as among older people.

    “These drugs are currently used by more than three million diabetic patients in the US alone, suggesting that several thousand could be harmed,” said the lead author Sonal Singh, an assistant professor of internal medicine at Wake Forest University School of Medicine, in North Carolina. His coauthor Yoon Loke, from the UK University of East Anglia, said that although the risk was small the drugs were used by half a million people in the United Kingdom.

    GlaxoSmithKline said that the paper “provides no new information on the risk of heart failure associated with the thiazolidinedione class.”

    “The risk of heart failure in diabetes patients and with use of these medicines is well recognised and is clearly identified in prescribing information to doctors in the UK . . . Type 2 diabetes can have devastating consequences . . . Rosiglitazone, therefore, has an important role to play as one of the medicines doctors can use to treat the two million patients currently diagnosed with type 2 diabetes in the UK,” said Alastair Benbow, European medical director at GlaxoSmithKline.

    Dr Fonseca said that the paper was about heart failure, “which has been well known to be associated with TZD [thiazolidinedione] use and has been a subject of a joint ADA/AHA [American Diabetes Association/American Heart Association] consensus paper, which was published in Diabetes Care” (Diabetes Care 2004;27:256-63 doi: 10.2337/diacare.27.1.256).

    Rosiglitazone and pioglitazone, a related drug, are known to increase the risk of congestive heart failure by increasing fluid retention and weight gain, he said. “This [latest] paper was a meta-analysis of congestive heart failure and thus represented an interesting but relatively incremental increase in knowledge on the subject.”


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