Monday, April 26, 2010

IS ROSIGLITAZONE SAFE? LOOKS LIKE THE END FOR THE "GLITAZONES ".

Since February, I have been reading all kinds of reports from the US senate, US FDA and many of my cardiology colleagues in USA on the dangers and lack of evidence of dangers of Rosiglitazones. Looks like the "noise" from ACCORD and RECORD just wont go away. The US senate is still investifating and the US FDA is not sure.
The question in point now has to do with the TIDE ( Thiazolidinedione Intervention with Vitamin D evaluation ), an ongoing trial comparing rosiglitazone against pioglitazone, to see which is better and safer, with Vitamin D in both arms by a factorial 2x2 design. Well, this trail had undergone enrollment, approved by FDA in 2009 and also by 227 safety monitoring committee in the many centers participating in the trials. Glaxo Smith Kline and Takeda had poured millions into the study. The question is, should it continue? Should the consent be re-obtained, in the light of concerns by Senate and FDA? or should it be allowed to continue, as it has a follow-up of 5.5yrs and in the Vit D arm, 10 yrs.
Indirectly, it also brings up the issue of whether the FDA and Senate, really think there is a concern. Some of us are not so convince, on the evidence that we have. It is a good drug. I do not use a ot of rosiglitazone, but I have not seen any increase incidence of angina or AMI in the few that I have used. My issue now is whether I should stop all my patients on Rosiglitazone and change them to something else. Fortunately, I do not have any patients on rosiglitazones and insulin ( the said troublesome combination ).
Whatever said and done, I think the days of the "glitazones" are number, not so much because it is a dangerous drug, but also because the unwanted publicity ( rightly or wrongly) have already make it a difficult drug to justify using. Should anything untoward happen ( even nothing related ), one would have great trouble trying to defend oneself, and in this difficult medical practice environment, these are stress that we do not need.
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