Monday, September 01, 2008

MORE ARB CONFUSION

Over the last weekend, while we were celebrating our Merdeka, cardiologist across the world were attending the European Congress of Cardiology ( ESC ) at Munich. So far, nothing earth shuttering has emerged from this meeting. I see from the world wide web that the Servier study on Ivabradine ( a new type of heart rate slowing drug, for heart failure), proved negative. The sstudy had the acronym "BEAUTIFUL". Actually, last year when they brought me to Bangkok for a meeting to discuss this drug and "BEAUTIFUL", I told them that it was a waste of time and money. Thank God, I was right.
Well, this ESC also saw the presentation of TRANSCEND. This is a clinical study to test the cardioprotective effect of Telmisartan. It tested the effect of Telmisartan against placebo, in 6,000 patients who were intolerant to ACE-I, with established cardiovascular disease or diabetes mellitus, and on 56months of followup. The reduction of MACE was the primary endpoint. Well, would you believe it. Telmisartan was no better than placebo. I am a little surprise, as it generated more questions than it answered.
We know for certain that ACE-I was obviously cardioprotective. We have a whole line of clinical trials to prove that, whether we wish to quote EUROPA ( perindopril) or HOPE ( Ramipril ) and many others. Yet some ACE-I / ARB studies showed that they are equivalent, like VALIANT, CHARM-ALTERNATIVE, etc. The ONTARGET shows that telmisartan was not inferior to Ramipril. And now, TRANSCEND tells me that Telmisartan is no better than placebo.
Guess how confuse I am now? How do I reconcile all that I read? Is it Telmisartan, or all ARBs? Is it statistics? Is it that ACE-I acts differently from ARBs? Or is it the study population? I don't know.
What I know is that, I may not be able to assume that all ARBs are the same. ACE-I is obviously good. All ARBs may not be the same as ACE-I. And the most upsetting, we now have two Boerhingher Ingellheim study and one Servier study that did not bring the desired results. We have spend alot of money.
Well, I suppose that is also why we do clinical trials. That is also why, medications are so costly. Just so that we know.

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