BMJ study questions “whether ongoing use of rosiglitazone is justified in any circumstance”

A large observational study has found a significantly higher risk of heart failure and death associated with rosiglitazone compared to pioglitazone. David Juurlink and colleagues in Toronto, Canada state in their conclusion:

Given the accumulating evidence of harm with rosiglitazone treatment and the lack of a distinct clinical advantage for the drug over pioglitazone, questioning whether ongoing use of rosiglitazone is justified in any circumstance is reasonable.

The researchers performed a retrospective cohort study in nearly 40,000 patients in Ontario, Canada who were 66 years or older and who started either rosiglitazone or pioglitazone treatment between April 2002 and March 2008. The study was published online  in BMJ on Tuesday.

The rate of death or admission to hospital for either acute MI or CHF was 6.9% among patients receiving rosiglitazone and 5.3% among patients receiving pioglitazone. After multiple adjustments for confounding factors the researchers found that “pioglitazone was associated with a significantly lower risk of the primary outcome compared with rosiglitazone (adjusted hazard ratio 0.83, 95% confidence interval 0.76 to 0.90).” They estimated that one additional event would occur for every 93 patients treated with rosiglitazone instead of pioglitazone.

An accompanying editorial by Corinne de Vries and David Russell-Jones praises the study but notes the possibility that the pioglitazone patients may have been healthier at baseline. They write that “it may be tempting to move away from prescribing thiazolidinediones altogether.”

An article by Helen Branswell in The Canadian Press reported that GSK, the manufacturer or rosiglitazone, “disputed the findings, saying other studies have determined Avandia is an important treatment option for appropriate patients.” GSK pointed out that observational studies can never rule out the possibility that the patients in each group were different.

Sanjay Kaul sent the following comment to CardioBrief:

Although such nonrandomized, claims data-based studies can be informative if done rigorously (as was the case with this study), they still lack the rigor to change policy or guide clinical practice. Only randomized controlled comparisons will resolve the debate about the differential efficacy and safety of rosiglitazone vs. pioglitazone.


===========================================================

Don’t lose touch with CardioBrief. Click here to sign up for a daily email newsletter.

===========================================================

Click here to follow CardioBrief on Twitter and receive instant notification of new posts and links

===========================================================

Trackbacks

  1. […] BMJ study questions “whether ongoing use of rosiglitazone is justified in any circumstance” (August 18, 2009) […]

  2. […] BMJ study questions “whether ongoing use of rosiglitazone is justified in any circumstance” (August 18, 2009) […]

  3. […] BMJ study questions “whether ongoing use of rosiglitazone is justified in any circumstance” (August 18, 2009) […]

Speak Your Mind

*