NEJM: Avandia increases MI risk 43%

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..increases risk of heart death by 64%.

And GSK investors go into meltdown...

I wonder if Actos is similar.

Yeah, I saw that in the paper today. I'm glad I have today and tomorrow off, so I don't have to answer all the constant questions over the phone. I don't have access to the UF library anymore. Can someone find the actual study and send it to me? I'd like to read it.
 
Yeah, I saw that in the paper today. I'm glad I have today and tomorrow off, so I don't have to answer all the constant questions over the phone. I don't have access to the UF library anymore. Can someone find the actual study and send it to me? I'd like to read it.

As of this morning, you can still view the entire article for free at www.nejm.org.
 
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After actually reading it, it looks like the 64% cardiac death thing isn't statistically significant. The 46% MI thing was barely (but still) significant.

I guess it's because Avandia has been shown to increase LDL in some patients. Actos doesn't do this. I'm guessing the FDA looks into this hardcore and the folks at Eli Lilly are licking their chops and prepping the "Avandia is evil, buy Actos" ads.
 
We're looking at 0.32& vs 0.27% for MI and 0.14% vs 0.08% cardiac mortality in 27,000 patients on a retrospective analysis.

Looks like GSK is getting hammered by the stock market.

To recommend the patients get off Avandia may not be the best at this time...there are other risk factors besides cardiovascular in diabetes.

I haven't formed an opinion yet... but sensational journalism is at it again.
 
I cant stand it when the media uses % increase and decrease to describe things. It just over sensationalizes minute differences. I much rather use absolute %'s, it makes things alot easier to comprehend. It was the same thing with ortho evra's 200% increase in clots, when it was like 0.1% to 0.2%. At work last night a guy called me scared to death to take his avandia becasue it did not want a heart attack. The NEJM recommeddations also sound rather harsh based on one meta-analysis (an inherently flawed retrospective study design)
 
Yeah, I saw that in the paper today. I'm glad I have today and tomorrow off, so I don't have to answer all the constant questions over the phone. I don't have access to the UF library anymore. Can someone find the actual study and send it to me? I'd like to read it.

One month and they took it away already? Heartless.
 
Check out platorian.studentdoctor.net for the link to the actual article.
 
Kinda funny, because today at the pharmacy I tech at we had some sales people from GSK come in to introduce a new drug and when my pharmacist started to question them about Avandia they got a little tounge tied to say the least. GSK told them to say "As of now the studies that indicate increased risks associated with Avandia may contain misleading data". Whatever that actually means...
 
The # are high . But how significant are they. I guess media hype!
Anyways this Avandia act at molecular level and have advantages in the long run. Doesn't it? (when compared to other oral agents)😕
 
I also hate when the media gets involved.:scared: The trouble is the study is flawed. Just because it is flawed does not mean it is wrong.

The effect appears to be independent of LDL levels. If it just raised the LDL, you could ameliorate the effect by adding a statin.

The trouble is Glaxo submitted similar data to the FDA quite a while ago. I can't understand why the FDA did not immediately communicate this to prescribers and order Glaxo to do a study to confirm or refute these findings.

One of the hardest things to do is counsel your patient's when the data is troubling but not conclusive. Would you recommend your patient's:

  • Switch to Actos
  • Stop the Avandia
I wish the FDA would be more consumer oriented and less drug company oriented.