Friday, April 20, 2012


The early results for the TIPS2 trial was presented at the omngoing World Congress of Cardiology in Dubai. Dr Alben Sigamani of St John's Research Institute, Bangalore, India, presented their findings, amidst much discussion.
Just to recap that in TIPS1 by the same investigators, they tested a half dose combination against standard dose over 3 months and found that the polypill was well tolerated, but the short term clinical response was rather limited. The polypill actually contained aspirin, ramipril, atenolol, thaizide and simvastatin.
In TIPS 2, they wanted to see if the short term clinical response is better and if the side effects are more. What the investigators found after 3 months of double dose polypill versus single dose polypill, that the full dose, in one pill was well tolerated and that there ws no increase in side effects. The clinical effects were double that on half dose. The BP reduction and LDL-C reduction was better.
As a treatment strategy, it looks feasible. Now we have to go prove that it does work in a large population, and that it will bring about clinical outcome benefits and not just short term benefits. What is equally important, if not most important, is the cost. So far, many big pharmas are not keen to support the project as they are not sure of the return on their investment. The big names running the trials are having problems, convincing big pharmas to come in and make the pill, and support the clinical trial. Pharmas know that should the polypill work, they are unlikely to be able to market it to individual doctors, and will have to depend on government preventive programs, and the government will squeeze them for their profit margin. Basically there is at the moment little money to be made in preventive cardiology.
Of course, the other question that also needs to be answered, is compliance with life style modification. Will patients on the polypill take the short-cut of abandoning their life-style measures, on the pretext that the polypill is protecting them. Thereby negating whatever good that the polypill may do.
So, although the concept sounds wonderful, lowering coronary risk factors, with minimal pills and hopefully, better compliance, in actual fact, we do not yet know if it will work. There are still many more hills to climb. Of course there are also many more large scale clinical trials on the way, some with sponsors already and some having difficulty finding sponsors.
Well, medicine has now become a business and pharmas are the big boys with the purse.
So polypill, what a good idea. But there remains more questions than answers.

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