Monday, September 14, 2009


Last year, in the European Congress of Cardiology 2008, with some pomp, Dr Roberto Ferrari ( how can you forget a name like that ) , presented the results of the BEAUTIFUL trial. BEAUTIFUL stands for " Morbidity-Mortality Evaluation of the If Inhibitor Ivabradine in Patients With Coronary Artery Disease and Left Ventricular Dysfunction (BEAUTIFUL) " trial. The acronym is less easy to remember. Essentially, this is a trial in the use of Ivabradine ( a new If channel blocker), for the reduction of major CV events in patients with LV dysfunction, in patients with HR >70/min. As we know from ESC 2008, the study failed to show that and Ivabradine is struggling to find a place in our heart failure treatment armentarium.

Well, at the just completed ESC 2009 at Barcelona, Dr Ferrari ( the present president of ESC ), again presented a post-hoc analysis of a subset of patients with stable CAD, significant angina and HR>70/min, and found that ( listen to this ), Ivabradine was shown ( post-hoc subset analysis ) to reduce major CV events espcially in those with LV dysfunction, with a HR of >70/min.

If this is not dredging a study for some positive result, I dont know what is. And for a reputable company like Servier to do this, with the president of ESC to do this, is surely disappointing and PITIFUL. He and servier must know that such findings, from a post-hoc analysis, is at best, hypothesis generating and cannot have any clinical relevance now, until more studies are done. We are promise that SIGNIFY is on the way, and will shed us more like, so let us all wait for SIGNIFY.

I suppose, I should give ervier credit for not using " ghost writers" and "guest authors" ( but then the study was basically useless, so why waste the money ). Well, although essentially useless, servier still completed the study and published it. That deserves some credit too. Maybe, to re-cycle a post-hoc analysis is to dredge and get whatever mileage out from the study that is possible, as money has already been spend.

Perhaps it may be better for big pharmas with negative studies, to let sleeping dogs lie and do another, properly conducted trial that will show whatever benefit the drug is proported to have so that we can study the data and see how to use the drug to benefit our patients. That of course assumes that the drug does have a role, and the research ( backroom boys ) have not made a mistake and wasted the company's time and money.

Yes, we know about BEAUTIFUL, and it is so PITIFUL the way Servier is going about it, and we all await SIGNIFY to tell us better. For the moment, nothing has changed. The good old drugs are still good.

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