Asian Heritage: Reason Not To Take Cholesterol-lowering Drug

[peter991]

This struck me as a bit strange. I have been on a statin drug (Lipitor 80mg) but my Cardiologist is still not happy with my fasting-cholesterol level.

He has switched me onto a relatively new drug called Crestor. The dosage is 20mg, once per day.

Crestor (Rosuvastatin calcium). I looked it up on the Internet and found, according to the Victorian (Australian) Government's website, that Crestor is unsuitable for people of ASIAN HERITAGE.

Why is this so?

Peter

[kat]

Interesting question. Could it have anything to do with enzymes?

[FBN]

Interesting question. Could it have anything to do with enzymes?

From the FDA Health Advisory:

"In order to minimize risks of myopathy and rhabdomyolysis (the most severe form of statin muscle injury), the revised label now explicitly states that the 5 mg dose is available as a start dose for those individuals who do not require aggressive cholesterol reductions or who have predisposing factors for myopathy. This includes patients taking cyclosporine, Asian patients, and patients with severe renal insufficiency."

Does not seem to have anything to do with enzymes, just a higher risk of myopathy...

News to me...

[Tammi]

Interesting question. Could it have anything to do with enzymes?

From the FDA Health Advisory:

"In order to minimize risks of myopathy and rhabdomyolysis (the most severe form of statin muscle injury), the revised label now explicitly states that the 5 mg dose is available as a start dose for those individuals who do not require aggressive cholesterol reductions or who have predisposing factors for myopathy. This includes patients taking cyclosporine, Asian patients, and patients with severe renal insufficiency."

Does not seem to have anything to do with enzymes, just a higher risk of myopathy...

News to me...

And there I was athinking that statins are perfectly safe when it has even been suggested that they should be added to our drinking water.

[Prakanong]

Interesting question. Could it have anything to do with enzymes?

From the FDA Health Advisory:

"In order to minimize risks of myopathy and rhabdomyolysis (the most severe form of statin muscle injury), the revised label now explicitly states that the 5 mg dose is available as a start dose for those individuals who do not require aggressive cholesterol reductions or who have predisposing factors for myopathy. This includes patients taking cyclosporine, Asian patients, and patients with severe renal insufficiency."

Does not seem to have anything to do with enzymes, just a higher risk of myopathy...

News to me...

And there I was athinking that statins are perfectly safe when it has even been suggested that they should be added to our drinking water.

As it was quoted at the Pharmaceuticals Asia Conference 2008 in Singapore last week, "All drugs are just poisons in moderation" - every drug has a AE (Adverse Reaction) for somebody - could be mild or it could mean death or be life threatening - first trial I ever worked on 4 people died and the trial stopped - drug was for IBS

Read JP Garniers (Outgoing CEO of GSK) lead article in this months Harvard Business Review - he is talking about progressive blockbusters - this is partly because you can test the drugs on one specific group of patients then releast the drug just for them - then move onto another group.

This is in reaction to a much tougher regulatory environment after Vioxx and the like. While phase 3 clinical trials are large scale they can not catch every adverse effect a drug may have esp long term. That is why we need better PMS (Post Marketing survelience) studies and indeed many countries such as Korea and Philippines demand them as part of their ongoing regulatory process.

As for different drugs actng on different races differently etc that is well known and part of the reason some countries regulatory bodiies demand trials have been conducted in their countries.