Wednesday, August 15, 2007


The US FDA is getting very active, reviewing clinical trial data, especially safety data, on completed trials and also on-going clinical trials. I am certain that this great vigilance must have something to do with the aftermath of the problem with Vioxx, and also Avandia.

Now comes the early warning on the group of drugs called "Proton pump inhibitors". Surprisingly it has nothing to do with defects in the Malaysian national car (as if we needed more bad news there). The two most important members of PPI are Omeprazole and Esomeprazole. These drugs are very useful in the treatment of gastric, hyperacidity disorders, including peptic ulcer disease, and bleeding peptic ulcers. In fact it is so useful that gastric surgery rates have been affected by them. There is now much less need to do gastrectomies for bleeding and severe gastric pains.

There is no doubt that the PPI has in some ways, revolutionalised gastric treatment. Well, that's the good news about PPI. Now for the not so good news. There is some early data, from two clinical trials, which seem to suggest that Omeprazole and Esomeprazole use seems to be associated with a slightly increase incidence of heart attacks, heart failures and heart related sudden cardiac death. However, the data is weak, as these two studies, did not well define what are heart attacks and heart failures, and sudden cardiac death. There are also other trials which showed no association between PPIs and heart attacks. However, in view of these early evidence, we cannot completely ignore it.

I have had to use PPIs because many of my patients are on aspirin and plavix, following stent implantation (bare metal stents or drug-eluting stents). They sometimes have gastric pains and sometimes even gastric bleed. So, many of them are given PPIs, sometimes even prophylactically. In view of this new evidence, I may have to be more careful. I wonder whether some of the late stent thrombosis problems that we are now wrestling with could have PPI as a contributing factor. So we have to be more vigilant.

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