Monday, September 27, 2010

ROSIGLITAZONE, THIS IS THE END.

The DG of Health released a statement over the weekend ( carried in this morning's new daily ), cautioning medical practitioners on the potential dangers of Rosiglitazone ( tradename: Avandia ). This warning is appropriate.
Glaxo Smith Kline, the manufacturers of Rosiglitazone has been battling the action for the last 3 years. Rosiglitazone is a drug for the
diabetes that acts by enhancing the peripheral utilisation of sugar by the the body cells. It is what we call an " insulin sensitiser ), as opposed to glibenclamide ( popularly called Daonil ), that acts by stimulating the pancreas to produce more insulin ( the secretogogues ). By a large, in adult diabetics ( especially those who are obesed ), there is adequate insulin in the blood stream, in response to a glucose load, but the peripheral tissues ( like muscles ) are resistant to the insulin ( insulin resistance ), so that the glucose cannot enter the cells for metabolism. In these cases, insulin sensitisers like rosiglitazone, helps to move the glucose into the peripheral cells, thereby enhancing cellular metabolism and in so lowering blood sugar. Sad to say, there are only two groups of drug at the moment who are commercially available, to fulfill this function, namely the biguanides like metformin, and the " glitazones " like rosisglitazone. The only other member being pioglitazone.
Back three years ago, the FDA had advised the company to put in a blackbox labelling, warning patients that there are risk with the use of rosiglitazone. They did not wish to ban its use. Recently, the FDA had again asked the company ( GSK ), to put an additional box labelling. They still did not wish to ban it. The UK Medicines and healthcare products Regulatory Agency ( MHRA ), has called for the drug to be removed, citing that it is a danger to health. Looks like the DG of Health Malaysia, has come to the same conclusion. However, he did not ban the use.
I can understand why? Afterall , we have only two group of drugs to help diabetics who have insulin resistance. Banning one of them ( " glitazones " ) will only leave us with Metformin. And as we all know, some patients cannot tolerate metformin, or should they have renal failure, they can't take metformin. Then what do we do? If we do not have the " glitazones "?
Anyway, what is the problem with rosiglitazone?
4 years ago, data came out from clinical research, that when they followup patients taking rosiglitazone, there was an increase incidence of water retention and swelling, almost like heart failure ( earlier posting ), and later it also became apparent, that there were more heart attacks amongst the diabetics taking rosiglitazone. Because of this increase incidence of water retention ( fear of heart failure ) and also increase incidence of heart attacks, the first warning came out. What made it worse was when the news first broke of these adverse effects of rosiglitazone, the manufacturers denied it. In fact, there were reports alleging that they were trying to hide the facts. That made us all very angry. It is now obvious, that there is some merit to the dangers reported. Now, the day of reckoning has come. Looks like more and more government will caution against the use of rosiglitazone, citing that the dangers of rosiglitazone far outweighs the benefit.
What I would like to know is if I have an obese patient with insulin resisitance, who cannot tolerate metformin, what shall I do?

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