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Prescribing Advice for GPs

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New RECORD but same tune

The Lancet has published the results of a long term study that aimed to assess the cardiovascular safety of rosiglitazone (Avandia®).

The study recruited 4,447 patients with type 2 diabetes on metformin or sulfonylurea monotherapy. The study was open label and last for a mean of 5.5 years. The primary outcome was cardiovascular death or hospital admission.

Participants in the study were randomly assigned to treatment with dual therapy of metformin and sulphonylurea or initial monotherapy (metformin or sulphonylurea) and rosiglitazone.

The primary outcome occurred in 321 patients taking a rosiglitazone combination and 323 patients in the active control. The difference was not significant and therefore rosiglitazone treatment was found to be non-inferior.

The study did find an increased risk of heart failure requiring hospital admission (Hazard Ratio 2.10, 95% confidence interval [CI] 1.35—3.27, p=0.001) and of fracture (risk ratio 1.57, 95% CI 1.26–1.97, p<0.0001).

It is also interesting to note that a greater proportion of participants treated with rosiglitazone were also treated with cardiovascular drugs by the end of the study. In particular, 9.2% more patients were using a statin (55.2% versus 46.0%) and 4.9% more were using loop diuretics (13.0% versus 8.1%).

The authors conclude that, "rosiglitazone does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs" with a caveat that, "the data are inconclusive about any possible effect on myocardial infarction.

The results of this study are consistent with what is currently known. Glitazones increase the risk of heart failure and fractures. Rosiglitazone has also been suspected of increasing the risk of heart attacks and while this study indicates no increased risk of cardiovascular death an increase in heart attacks cannot be discounted.

Action: Clinicians should continue to implement the existing guidelines. Glitazones (and gliptins) are considered as alternatives to metformin or sulphonylureas when these agents are contraindicated or poorly tolerated. Pioglitazone currently has fewer prescribing restrictions and may be a better choice where a glitazone is indicated.

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2 Comments to “New RECORD but same tune”

  1. "In particular, 9.2% more patients were using a statin (55.2% versus 46.0%) and 4.9% more were using loop diuretics (13.0% versus 8.1%)."
    Isn't it a good thing that more patients were using a statin-I don't think that this can be seen as a bad thing or related to Rosiglitazone use.

    Comment by Paul — June 22, 2009 #

    1. Paul,

      It certainly is a good thing being on a statin if you are at risk of cardiovascular events. The point here is that there were differences between the two arms of the study in the use of statin medication; that difference may have had consequences in the differences observed between the patients or corrected for some differences such that certain events appeared to happen at the same rate.

      So, essentially we have a concern that rosiglitazone may cause heart attacks. Statins stop heart attacks. The rate was similar between the two arms so was the higher use of stains in patients taking rosiglitazone balancing the increased risk from taking rosiglitazone? The answer is we really don't know and this study therefore doesn't really change anything although it may be used to suggest that rosiglitazone has no additional heart attack risk based on the raw data.

      Comment by Matthew Robinson — June 26, 2009 #

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