medicalCPA

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I've been meaning to ask this for quite a while, and since my drug knowledge is scanty, bear with me. You know those "building story" Crestor (rosuvastatin...I actually remembered the name! lol) commercials on TV? They say plaque is dangerous, and Crestor helps slow the buildup of plaques. However, the commercial also features the message, "Crestor has not been shown to reduce heart disease or heart attacks." So WTH does the drug do? If it claims to reduce plaques, but DOES NOT reduce heart disease - the more relevant outcome, I think - why in the world would people take a drug that has no apparent benefit? Or am I missing something?
 
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MountainPharmD

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Asking questions like that will lead you down the path to enlightment! Read this article: http://www.nytimes.com/2008/09/02/b...widely used drug, question&st=cse&oref=slogin

The FDA requires a drug manufacturer to prove a drug is safe and effective before it can be sold. Effective meaning it does what the manufacturer says, safe in that it doesn't immediatly kill you.

What SHOULD the FDA ask in addition to these questions? How about does the drug effect outcomes in actual patients? The Enhance trial is a perfect example of this.

As WVU pointed out the recently relesed Jupiter trial does show beneifts to taking Crestor for patients with LDL-cholesterol levels <130 mg/dL and elevated CRP levels. Good information but not a big stretch for the drug company. They are just trying to increase the number of people taking the drug. If the study failed no big deal this group wasn't routinly prescribed a statin anyway.
 
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bacillus1

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Crestor is a statin drug, so it inhibits an enzyme involved in cholesterol synthesis. That means that it slows down atherosclerosis buildup.

When you form blood clots and whatnot, you don't have heart disease yet. What they mean is that the drug does not treat existing heart disease. It just prevents the formation of heart disease due to blood clots.
 

acetyl

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Wilford Brimley! I've always believed there are mroe side effects with Crestor in the rhabdo category... I steer my relatives, and folks I like, clear of that drug in favor of atorvastatin.
You've found my identity! And remember to call Liberty Medical to get your testing supplies. Check that blood sugar. And check it often!

In the JUPITER study, there was only 1 in 8901 people on Crestor who had rhabdo; 0 in the placebo group....and 10 vs. 9 in the myopathy category (drug vs. control) so really not that prevalent.

But I must digress. How shady is it that the LEAD author of the study, a study designed to change guidelines and treatment, holds patents related to testing of high sensitivity c-reactive protein-which is licensed to Astra Zeneca!
 

medicalCPA

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First, an excerpt from crestor.com (see bolded)...

"In adults, CRESTOR is prescribed along with diet for lowering high cholesterol. CRESTOR is also prescribed along with diet to slow the progression of atherosclerosis (the buildup of plaque in arteries) as part of a treatment plan to lower cholesterol to goal. CRESTOR has not been determined to prevent heart disease, heart attacks, or strokes."

Basically, all the drug does is lower cholesterol, but taking the drug does not mean that it will prevent one from getting heart disease in the future. So why take it? I guess I don't see the point.

The symptom, not the disease, is what's being treated. That's a valid principle, and it works in diseases like cholera (Andromeda Strain, anyone?). With cholera, a patient loses copious amounts of fluid and dies of dehydration. Hydrate the patient, and he will live because with time the immune system will fight off the bacterium. But treating the disease symptom only gives the body time for the immune system to fight off the disease agent, and in heart disease there is no disease agent for the immune system to fight.

So why even take the drug? The JUPITER trial (which I must admit I haven't read. Priapism if you're reading this, please tell me where I can find a copy) says rosuvastatin cuts heart disease in half. Doesn't that still mean that even with the drug there's still a 50/50 chance of dying from heart disease? Like I said, I'm probably missing something or interpreting something wrongly, which is why I created the thread in the first place.
 

WVUPharm2007

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lol...I haven't actually read the entire thing until now...I just went off what the news wires said. After reading it...this study was lame as hell...lol. I suppose now they will be wanting to put it in the water like that meddling psycho from the dept of cardiology up at The Clinic in C-Town says.
 

WVUPharm2007

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So why even take the drug? The JUPITER trial (which I must admit I haven't read. Priapism if you're reading this, please tell me where I can find a copy)
Here ya go, stretch.

Doesn't that still mean that even with the drug there's still a 50/50 chance of dying from heart disease?
No...it doesn't. That would only be the case if 100% of the population died from heart disease.
 
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If you're going to link info like that, then you need to also add a comment about the commentary and why you like it.
Well, for one, I like how it goes against a lot of the hype of the trial by pointing out a lot of flaws with how the results are being presented and things that could be improved. Like, for one, the NNT for events being higher than reported for the actual length of the trial (1.9 years) versus predicted lengths in the trial by the authors (2 years and 4 years).

He makes good points about how the trial didn't compare treatment vs. placebo in patients with low-risk CRP levels and no hyperlipidemia, about how hs-CRP isn't specific for just atherosclerosis (can be affected by cancer, autoimmune disease, and heck, just being female), about how we don't know the long-term effects of intensive statin therapy and lowering LDL to the amounts it was lowered to in the trial.

One thing he failed to mention when he talks about how Crestor is more expensive than the generic statins are, at least in the real world, cash prices that I've seen of Crestor vs Lipitor is that Crestor is slightly less expensive per day than Lipitor...right now. However, Lipitor is slated to lose its patent in March 2010, and so, I feel if there is a "mad rush" to convert people to Crestor from Lipitor, the life of that would only be as long as the remaining life of the patent. Plus, the study was funded by AstraZeneca, and Dr. Ridker is affiliated with them and has the patent to the hs-CRP assay...

Did you notice that 15.6% of those in the study were smokers and 41.4% had metabolic syndrome? Both are causes for increase in CRP, and those populations have an increased risk of CVD anyway. Unfortunately the trial doesn't specify to which groups those subjects belonged or if they were split evenly between groups (probably not because of the randomization technique). These were all supposed to have been "apprently healthy" subjects."

Like many others, I don't think this trial warrants a change in guidelines or practice. Further research? Sure. But, as far as statins lowering CRP, that's been proven before with PRINCE, PROVE IT/TIMI 22, etc.
 
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ItsOverZyvox

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Well, for one, I like how it goes against a lot of the hype of the trial by pointing out a lot of flaws with how the results are being presented and things that could be improved. Like, for one, the NNT for events being higher than reported for the actual length of the trial (1.9 years) versus predicted lengths in the trial by the authors (2 years and 4 years).

He makes good points about how the trial didn't compare treatment vs. placebo in patients with low-risk CRP levels and no hyperlipidemia, about how hs-CRP isn't specific for just atherosclerosis (can be affected by cancer, autoimmune disease, and heck, just being female), about how we don't know the long-term effects of intensive statin therapy and lowering LDL to the amounts it was lowered to in the trial.

One thing he failed to mention when he talks about how Crestor is more expensive than the generic statins are, at least in the real world, cash prices that I've seen of Crestor vs Lipitor is that Crestor is slightly less expensive per day than Lipitor...right now. However, Lipitor is slated to lose its patent in March 2010, and so, I feel if there is a "mad rush" to convert people to Crestor from Lipitor, the life of that would only be as long as the remaining life of the patent. Plus, the study was funded by AstraZeneca, and Dr. Ridker is affiliated with them and has the patent to the hs-CRP assay...

Did you notice that 15.6% of those in the study were smokers and 41.4% had metabolic syndrome? Both are causes for increase in CRP, and those populations have an increased risk of CVD anyway. Unfortunately the trial doesn't specify to which groups those subjects belonged or if they were split evenly between groups (probably not because of the randomization technique). These were all supposed to have been "apprently healthy" subjects."

Like many others, I don't think this trial warrants a change in guidelines or practice. Further research? Sure. But, as far as statins lowering CRP, that's been proven before with PRINCE, PROVE IT/TIMI 22, etc.
I have no clue what you just typed here.. are you drunk or something?
 
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