IMPROVE-IT November official.

Results of the eagerly-awaited and highly controversial IMPROVE-IT trial are finally going to be revealed. The American Heart Association has announced that the trial will be presented by Chris Cannon on November 17 at 11:51 AM (central time) in Chicago at the group’s annual scientific sessions

 

...followed shortly thereafter by layoffs. The company line on the failure of IMPROVE-IT will be " pay no attention to that man behind the curtain."

 

Let's face it. We all knew it was a failure with the very first delay.

Let the lawsuits ensue.

 

Wasn't there a bulletin that just came out giving background info on ENHANCE? What could that mean?

 

There's still time to change the study endpoint! Ohhh, Fred-yyyyyyyy?

 

Secondary end points at play too

 

How does this usually work? Will info be leaked before that day or do we have to wait for formal presentation?

 

No official leaks before the presentation. However the only real question is how bad the data actually is.

 

May surprise many nay Sayers with some positive data.

 

Sure... Some positive pts....worth the cost of the trial and the failure to ....

 

Oh, I'm sure they'll find a way to bend the truth. If they don't, then I'll be surprised.

Zetia is a worthless pice of sh!t. We all know that.

 

If there is even a shred of positive news, then we know it will be nothing but more Merck lies. The FDA will know it, too. I just hope it doesn't show that Zetia kills people, too. Merck has a tendency to kill people with its products.

 

Patent expires 1st quarter 17 is all that matters/

 

For all intent and purposes, the patent expires the moment IMPROVE-IT demonstrates how utterly worthless that drug is.

 

improve it will demonstrate very little either way. the medical community is not treating patients with low LDLs with high dose statin or combinations.
the only question it will answer among thousands of potential questions is combination better than maxed out single drug in patients who are already at goal.
this design is not even relevent in the real world.
not sure why oxford designed a study that answers a question that no one was asking.

 

Can't even go to 80 mg dose of simva anymore

 

This trial will leave us with more questions like:
1. Why was the study designed this way?
2. Why did it take so long to find out what we already knew?
3. How does this convince a doctor not to max the dose of atorvastatin or soon to be generic Crestor?
4. Is a pill without a CV benefit worth the extra money?
5. Should this product stay on the market?
6. How long before layoffs?

 

Answers:
1. Hmmm…
2. Hmmm…
3. Hmmm…
4. Hmmm…
5. Yes! we need the money, doctor!
6. 3 months

 

Correct me if I am wrong here, but wouldn't they have halted the study if there was an apparent risk of death, or increased harm with Zetia vs. other arms? Furthermore, wouldn't the study have been stopped early if there was clearly a very significant reduction in events/mortality rates in the Zetia arm? Therefore, it seems to reason there is going to be either no benefit or slight benefit in outcomes data. All of which could be partly related to the study design.

 

They would have stopped the study if there was an increase in mortality. Doubtful Zetia has this problem. Futility and other issues regarding lack of effectiveness is exactly why there is this strategy to delay. Zetia is still on the market and presenting no good news wrapped in an explanation of poor study design will be damaging to sales. The closer Merck can get to patent expiration before imploding the better.