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Rosiglitazone safety dilemma unclarified by new data

By News team

Uncertainty around the cardiovascular safety of rosiglitazone for patients with type 2 diabetes continues with the recent publication of new data on the matter.

In an updated meta-analysis, published online in the Archives of Internal Medicine on 28 June 2010, researchers examined 56 trials, which included 35,531 patients who had received either rosiglitazone or control therapy.

Rosiglitazone therapy was found to increase patients’ risk of myocardial infarction (MI) but not cardiovascular death, compared with controls (P=0.04 and P=0.86, respectively).

On the same day JAMA published online a retrospective cohort study looking at the cardiovascular outcome of type 2 diabetes patients receiving rosiglitazone versus those taking pioglitazone.

In the analysis of 227,571 patients rosiglitazone, compared with pioglitazone, was associated with an increased risk of stroke (adjusted hazard ratio 1.27, 95% confidence interval 1.12–1.45), heart failure (1.25, CI 1.16–1.34), death from all causes (1.14, CI 1.05–1.24) and a composite endpoint of acute MI, stroke, heart failure or death (1.18, CI 1.12–1.23).

“Since 2007 there has been doubt raised about the safety of rosiglitazone with regard to MI and cardiovascular death,” said Sally James, diabetes and divisional pharmacist for medicine, Royal Liverpool and Broadgreen University Hospitals NHS Trust.

“Several large studies have been published thereafter that back up some of these findings in relation to myocardial ischaemic events — although some other studies have tried to disprove this, especially with regard to mortality.”

At the American Diabetes Association’s 70th Scientific Sessions (held in Orlando, Florida, 25–29 June 2010), a post-hoc analysis of the “Bypass angioplasty revascularization investigation 2 diabetes” (BARI 2D) study was presented.

According to the abstract authors, although use of rosiglitazone among patients with type 2 diabetes and coronary artery disease was associated with more fractures, compared with no thiazolidinedione treatment, no increase in major cardiovascular events or death was observed.

Natasha Jacques, principal pharmacist for diabetes at Heart of England NHS Foundation Trust, told Clinical Pharmacist: “The JAMA analysis is a very large cohort study and really seems to confirm the results of previous studies — that there appears to be an increased risk of adverse cardiovascular events, including heart failure and death, with rosiglitazone versus pioglitazone.

“Nevertheless, these results are in conflict with the post-hoc analysis of the BARI 2D findings, which shows no increased risk of MI or cardiovascular death with rosiglitazone.”

Ms Jacques added: “Despite the confusion surrounding the use of rosiglitazone, my experience is that in practice rosiglitazone has in many cases been replaced by pioglitazone due to the ongoing safety concerns.

“It will be interesting to see what the Food and Drug Administration decides about the future of rosiglitazone on the US market, since this [imminent] decision is likely to influence what happens in the UK.”

Citation: Clinical Pharmacist URI: 11016968

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