Tuesday, March 31, 2009


It has been many a cardiologist dream to have a "polypill " containing an anti-platelet, a statin, and some anti-hypertensive drugs, in the hope that this will primarily or secondarily prevent CAD. Well, the first step has been taken by Dr Salim Yusuf and co-workers, mainly from India. I am sure that Dr Yusuf was there to lend his name and his considerable contacts in the drug trial world, to be the PI and also show the Indians how to do large scale clinical trials. Well, in India, without the FDA, Dr Yusuf can concort drug regimes that he will otherwise be unable to do in Canada / USA.
Be that as it may, Dr Yusuf and co-workers, undertook the TIPS trial, the results were presented at the ACC yesterday. TIPS was the accronym for The Indian Polycap study. They studied 2,000 over patients between the ages of 40-80 years. These subjects had no know cardiovascular disease. They were given the polycap pill, or aspirin alone, or zocor alone, or each anti-hypertensive ( tenormin, ramipril, HCT ) either alone or in various combination for 3 months and followed up. Obviously it was not a test of clinical events, but only to see if the concept is possible and that there be no important ill-effects. They were just measuring BP lowering and LDL-C lowering. These were essentially surrogate end-points. Nothing hard. The Polycap pill contain asprin 100mg, Ramipril 5 mg, Zocor 20 mg, HCT 12.5 mg, Tenormin 50mg. Well, to cut a long "Indian " story short, they found that, the Polycap pill was safe and relatively free of side effects. There was an 18% default rate, Some of the Indian centers were not so geared towards clinical trials and so the BP level reduction and also the LDL-C level reduction was less than when they were taking the drugs alone.
All in all, this study did not seem to be well done. I suspect that it got to ACC because it was of public health interest and also the lobbying power of Dr Yusuf.
Anyway, we can take heart that a first step has been taken to invent a polypill, and that it can be safe combined and administered. Much work still needs to be done.

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