Vytorin Update: Preliminary Study Results Today
15 CommentsBy Ed Silverman // July 21st, 2008 // 8:09 am
Both Schering-Plough and Merck pushed back their second-quarter earnings announcements from this morning until after the stock market closes because Terje Pedersen, of Ulleval University Hospital in Oslo, Norway, will provide an update on the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study.
The drugmakers are hoping the study may provide some insight into clinical outcomes with Vytorin, at least among patients with aortic stenosis, which is a cardiac valve abnormality. There is, however, a debate about whehter SEAS will be truly meaningful, given the trial design, the endpoints being measured and that aortis stenosis is rather uncommon. Here is some background.
And so it will be very interesting to watch how the preliminary info is spun by Merck and Schering-Plough, which have suffered an enormous drop in Vytorin prescriptions and revenue thanks to their handling and subsequent interpretation of the controversial Enhance trial.
UPDATE: In an investor note this morning, Deutsche Bank analyst Barbara Ryan writes: “This suggests that a meaningful result has likely emerged from an analysis of SEAS. Recall that SEAS tested whether aggressive cholesterol lowering (comparing Vytorin 40/10 to placebo) in patients with moderate AS can slow progression of AS, reduce number of valve replacements and reduce the incidence of CVD outcomes.”
By the way, we would like to add that a recent study in the American Journal of Cardiology appears to suggest that Pfizer’s Lipitor failed to make a dent in patients with aortic stenosis. However, this was a very small study. Here is the abstract. (Thanks to a loyal reader for pointing this out).
Joining Pedersen will be Richard Peto, professor of medical statistics and epidemiology and co-director of the clinical trials service uUnit, University of Oxford; Rory Collins, professor of medicine and epidemiology at the University of Oxford and co-director of the clinical trials service unit; Ingar Holme, professor of biostatistics, University of Oslo and Ulleval University Hospital, Oslo, Norway, and the SEAS steering committee statistician.
The London panel will be joined by Eugene Braunwald, professor of medicine at Harvard Medical School, who will participate via web link, Robert Califf, professor of medicine and head of Duke Clinical Research at Duke University, via phone link.
Justice in MI
Will be interesting to hear. The TASS study cited (Lipitor and AS) seemed to me to have a very small N, but I don’t know the relevant statistics for a study like that.
As discussed on earlier thread on SEAS, other studies have shown some impact of statin use on progression of both aortic stenosis and sclerosis. What’s interesting is that this was independent of LDL lowering, suggesting some other property (anti-inflamm?) might be involved.
Condor
“SEAS — A Comical Farce, in Three Acts — Sponsored by those Odd Folks at Schering-Plough!”
To find out why it is likely a stunt, read this:
http://shearlingsplowed.blogspot.com/2008/07/seas-comical-farce-in-three-acts.html
Nutty. Just nutty, eh, Ed?
And to think tha I woke up extra-early, out here on the West Coast. . . for THIS?! Sheeh. Just give me the projections for the second half, Mr. Clark (he being CEO of Merck).
Dan
As a combination medication, Vytorin should be reserved for use by specific patients with lipid disorders, I believe, as well as those who do not respond to statin medications.
The statin component of Vytorin, as with other statin medications for abnormal lipid profiles, are well established regarding thier safety and efficacy. In fact, some have called them one of the few truly beneficial types of medication for a number of reasons. Some take statins for preventative reasons, as others who take aspirin for similiar reasons.
Condor
Schering has opened badly on the NYSE — off 5.6 percent in the first few minutes of trading — falling through $20.60 now.
Half a million shares in the first ten trades.
I’d say that the market has sniffed-out a pig, despite its lipstick.
SPRI
Even if by chance there is some effect of Vytorin on the progression of AS or CV M & M, it’s probably due to the simvastatin component in Vytorin. Simvastatin alone has been shown to have beneficial effects in several populations of patients. it may be working its magic again and can be had for pennies a day rather than dollars.
Condor
Exactly, SPRI (Nice handle by the way! Cheeky!) — This is old Rome — Bread and Circus stuff, for the unwashed masses. YMMV. Namaste.
Condor
Now falling through $19.65 (Down 8.68 percent). Heavy volumes. Gee — this looks to be a real swell idea, Mr. Hassan.
Jeffrey Clark, CEO of Beaker.com - The Online Community for Life Sciences Professionals
With so many positive earnings report last week (Abbott, J&J, Medtronic, St. Jude, etc.), it seems the tide is turning as the ‘pure play’ drug makers take their turn at the mike…
Paul Rosenblit MD
Great news for Vytorin’s first outcome study.
Especially after we discovered that ENHANCE had been criticized by influential MDs, who had not known that VYTORIN in ENHANCE performed as well as, or better, as Atorvastatin performed in the ASAP-extended, RADIANCE-1, and Cashmere studies, and better than Niacin-statin in ARBITER 2 study. We had so-called critics, who actually knew very little about FH patients and what was to be expected from CIMT. Clean (lacking lipid) arteries progress very slowly (fibrosis) as in ENHANCE. It has become an embarassment for the ACC, the Cleveland Clinic and Walter Reed Hospitals that carried on so poorly, harming so many patients, who were ultimately influenced to stop taking life saving lipid-lowering drugs.
Justice in MI
Dr. R. - Candidly, I don’t follow your point, although I read your intensity in making it.
What, precisely, are you saying is the “great news” we now have about Vytorin we didn’t have before.
Genuine question. My wife is taking it.
SP 2
Yup, great news! Vytorin lowers cholesterol and reduces CV events better than placebo! This stopped mattering 10 years ago!
BPW
Fred tries to spin his magic once more, but the wand isn’t working!
Pharmacritique
I don’t understand why SEAS is too small when it comes to adverse events like cancer, but large enough to prove a preventive effect in coronary outcomes.
Lisa Van S
ITS a DUD!!!
SEAS sick
SEAS is very disappointing. Not for the AS endpoint- this could be anticipated vs. other statin trials (although it does put a dent on the hypothesis of sterols and AS) and is clinically pretty meaningless.
The biggest trouble spot is that this trial design (placebo vs. a combination therapy of which one component is unproven) is a back door placebo-controlled secondary prevention trial with only a 22% RRR despite a 61% LDL reduction- this is underperformance if you (albeit cautiously) compare to other high risk populations studied with simva vs. placebo… 4S, HPS…. makes you wonder how much opportunity there is within IMPROVE IT to show that simva + ezetimibe is better than simva alone. So, the trial is strictly interpreted as negative by its primary endpoint, not surprising for the negative endpoint of AS, but hiddenly underperforming for the “positive” finding of the RRR vs. placebo. There is no reason to use combination simva + ezetimibe over simva alone based on this trial. Await further evidence.