 |
 |
|
Rapid Responses to:
|
|
Electronic letters published:
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif){kind=icon}
More on the Rosiglitazone story
|
|
|||
|
Francisco J Criado, MD Hospital Privado del Sur- ICU
Send rapid response to journal:
franciscocriado2002{at}hotmail.com Francisco J Criado
|
The paper published the last June 14 th in The New England Journal of Medicine “ Rosiglitazone rises the Cardiovascular risk and myocardial infarction” deserves at least a comment for the ingenuous readers of this weekly “ scientific” journal” with the highest impact factor.
The mentioned meta-analysis generates at least the following comments concerning the validity of it’s results..
1 The absence of CV events in some non considered papers for the meta-analysis is no motive to exclude them, by the contrary; it should be very interesting to know about them, even more if the results don’t agree with the present analysis. 2. - The number of the control groups of the small trials is 4.000 patients less than in the big randomized, double blinded control studies. (ADOPT y DREAM) 3. The authors mix in the evaluation papers with patients with less than 14 weeks of follow up vs. papers with more than 100 weeks of follow up. When we analyze those 6 papers, we couldn’t find statistical difference between the Rosiglitazone group and the other groups. Even more, those groups have less CV events and AMI than the interventional group. 4. The independent evaluation of the only 5 papers with more than 100 weeks shows that the interventional arm has fewer events than the control group!!!!! 5. Rosiglitazone is a European developed drug by Glaxo Smith Kline French Group and the Pioglitazone is developed by an American pharmaceutical group which is clearly benefited by this analysis without the same statistical (meta-analysis) trial. 6- The Peto method (statistical method used by the authors) is appropriate when trials have roughly equal number of participants in each group and treatment effects are small. Indeed, it was developed for use in mega-trials in cancer and heart disease where small effects are likely, yet very important. This method is also unsuitable if there are large imbalances in the size of groups within trials. Statistical bias. The Simpson Paradox: Is a statistical paradox that occurs when you mix results of different groups. (2) We consider that the NEJM has the academic seriously condition not to be responsible of the author’s opinions but to have an independent editor’s committee, or we are in a new Vioxx era with US$ 700.000 reprints sold to the industry. References: 1- Nissen , S E.; Wolski ,K: Effect of Rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes.N Engl. J Med 356,2457, june 14, 2007. 2- Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.5 [updated May 2005]. In: The Cochrane Library, Issue 3, 2005. Chichester, UK: John Wiley & Sons, Ltd. |
|||
