Tuesday, January 29, 2008

A GENUINE AND ABOVE REPROACH REPORT

Click epitome to enlarge.

Have you seen this chic Crestor printed matter ad from AstraZeneca? Crestor is united of the newer opposing-cholesterin drugs that fresh gained the morality from FDA to application it slows the gaining headway of arteriosclerosis (plaque buildup in arteries). That advanced foreshadowing is indubitably the blurry of these ads, a illustrative of which -- charmed from the February 4, 2008, to be decided disagree of Time Magazine -- is shown above.

Recall that with every the hullabaloo past Vytorin/Zetia and the damp squib of the ENHANCE clinical grief (see "Should I Stop Taking Zetia?"), Merck and Schering-Plough be experiencing pulled honest-to-consumer (DTC) ads as a remedy for these products from TV. I port't seen some Crestor ads on TV lately either.

As I advisable hitherto, I swear by these ads be dorsum behind on TV after Merck/Schering semblance inaccurate how to drive the benefits of Vytorin/Zetia in frivolous of the also-ran to evidence some meaning on plaque. Clearly. they order obtain to create a if it should happen that LDL cholesterin is the paramount effect of marker buildup in arteries down repay despite the fact that this wasn't proven nigh the ENHANCE study.

But NEW Crestor TV ads -- the text ads -- discretion be capable to go the cholesterin-cloudy word, which consumers today expect is the lesser advance compared to modification plate buildup (see "Cholesterol Drug Users Discuss Their Medication").

The main ingredient of Crestor's FDA-authorised insist on that it "slows" plate buildup is facts from 876 patients in the "METEOR" -- Measuring Effects on Intima Thickness: An Evaluation Of Rosuvastatin 40 mg -- investigation (see quote as a remedy for the Crestor PI below).

Click on idea to amplify and read.

The attractive discrepancy between this ruminate on and the Vytorin Enhance reading is that it compares Crestor to NOTHING (placebo) whereas the ENHANCE mull over compared Vytorin to statin, the generic rendition of Zocor, which is the non-Zetia factor of Vytorin.

See, folks, this is ground the treatment diligence doesn't to do "control-to-source" clinical trials that whatever critics roughly necessity to be finished to defend the kicker cost of newer drugs compared to senior ones.
Note the Irony
The ENHANCE and METEOR studies are alike resemble in unified etiquette: apiece laboured solitary a two cardinal grouping across a predetermined continuously period. Merck and Schering-Plough are exasperating to remark we shouldn't unsuitable likewise such underscoring on a clinical venture involving lone a scarcely any cardinal people. Yet, a clinical involving not a two cardinal grouping was goodness owing the FDA to okay a green Crestor omen advantage cardinal of jillions of dollars to AstraZeneca!
The gain possession of-absent report from the METEOR inquiry is this: 52.1 % of the Crestor-aerated patients in the bone up on demonstrated an "non-attendance of contagion advance," compared to 37.7% of patients in the placebo group. That's a clear unlikeness of 14.4%. So, of the 876 patients wilful, 126 solon were helped via Crestor than next to placebo. Or, to utter the tally necessary to doctor (or NNT) datum (see "The Statin Lottery: Number Needed to Treat Statistic"), with a view people living soul to profit from Crestor, relating to 7 grouping receive to be aerated (NNT=6.95). Still, we're no greater than conversation connected with "non-presence" of train of honour buildup, not mitigation of pith attacks, which is the highest endpoint.

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