Comments on: Ladies & Gentlemen: The Enhance Study & Slides

By: steve

steve — Wed, 02 Apr 2008 04:11:16 +0000

This study was looking to add one more indication to the drug Vytorin. I read the NEJM article and Vytorin still lowers LDL, triglycerides, and C-reactive protein more than a statin alone, which was the primary goal of this drug when it came out. I wonder if they tried Crestor or Lipitor with this type of indication if the test would have yielded the same results.

(I’m not employed by the drug industry, but a systems analyst by trade)

By: Pharma News 3_29 « Impactiviti blog

Pharma News 3_29 « Impactiviti blog — Mon, 31 Mar 2008 10:14:15 +0000

[...] comment. Good summary with more links from Ed Silverman (Pharmlot blog - one of the best btw!) here. Prasugrel gets a boost - The investigational antiplatelet drug prasugrel plus aspirin produced a [...]

By: BPMD

BPMD — Mon, 31 Mar 2008 05:04:17 +0000

How appropriate! A circus tent at the top of the story. This whole ENHANCE fiasco has been a 3-ring circus over the past 10 weeks. The same theories keep circling. The real truth is that the trial faile. The real disaster was created by top management, particularly at Schering-Plough, who profited greatly along the way while making bad decision after bad decision about what to do. These executives have failed the company.

By: B. Martin, MD

B. Martin, MD — Sun, 30 Mar 2008 22:12:37 +0000

The authors wrote in the NEJM, “The exclusion from the statistical analyses of patients with missing data or biologically implausible measures of the carotid-artery intima–media thickness (defined as a difference of >0.1 mm between visits) did not change the primary or secondary outcome results (data not shown).”

However, the numbers of patients in either group are not provided. If these numbers are considerable (and the S-P timeline suggested that they were), they could completely undermine the statistical power and/or validity of the ENHANCE study and any subgroup analysis. I’m surprised there’s no substantive discussion of this very important caveat. That’s the big elephant in the parlor, imo.

By: Ed Silverman

Ed Silverman — Sun, 30 Mar 2008 19:57:42 +0000

Hi Jeff,

Done. Thanks for reminding me. Sometimes, I work too fast for my own good.

Regards
ed

By: Jeff

Jeff — Sun, 30 Mar 2008 19:28:33 +0000

Ed, you should note in your article that both editorialists are Merck consultants. Great move by the NEJM.

By: Paul

Paul — Sun, 30 Mar 2008 17:59:54 +0000

I find all these cardiology experts so hypocritical. These are the same guys (yes all are guys) who praised the value of Lipitor when it came out and it had absolutely no proof of clinical benefit.

Lipitor went on to be used far more than Zocor and Pravachol which had lots of hard clinical evidence of reducing endpoints. All these people: Topol, Nissen, Ridker, etc. etc. were on the lecture circuit paid by Pfizer and touted that “lower must be better” even if there was no proof.

Now they are all trying to come across as saints on the side of good judgement. Give me a break!