ENHANCE RESULTS- UNCOVERED

The results of the ENHANCE trial were released today- a year later than planned, and only a month after the media outcry for the results. The data was amazingly bad. A negative primary endpoint, negative secondary endpoints- and lots of trends pointing in the wrong direction. The addition of ezetimibe to simvastatin resulted in slightly more plaque in the carotids, slightly more heart attacks, slightly more death, slightly more need for coronary stents, and slightly more elevation of liver function tests.

This is really bad- worse than almost anyone would have imagined. Steven Nissen- probably the most influential cardiologist around- was quoted as saying “"The data show no benefit for ezetimibe on top of simvastatin. In fact, the data on both the rate of progression of atherosclerosis and cardiovascular events are trending in the wrong direction. This is a pretty clear failure. Physicians should now stop using ezetimibe or Vytorin except as a last resort."

I like to think that as a cardiologist, I am pretty good a predicting the results of this trials- and reading the tea leaves. Still, It feels particularly good to have predicted this one so right. https://www.bestcashcow.com/stocks_-_options_-_mutual_funds/article/pharmaking/zetia-and-vytorin-wheres-the-beef.

One month ago, I predicted this trial would fail. My only mistake- and a big one- was to think that the data wouldn’t be released until the ACC- So I didn’t have the big short positions I was planning.

How can you- and I- play this now. I believe the trade remains the same. Short SGP and MRK. SGP was down 8% today and MRK was down less than 2%. The market doesn’t fully appreciate the significance of these results. SGP relies heavily on Vytorin and Zetia. Merck is more diverisified- but this is still a big revenue source for them (and the plan for Zetia/atorvastatin(Lipitor) looked like another potential blockbuster for these two. Many analysts- including the guy at Goldman are saying that this data will not affect scripts. The best indication I can find is to look at the poll going on at theheart.org- a website for cardiologist. So far, 55 cardiologists have answered the question “Will you be less likely to prescribe Ezetimibe?” At present the “yes” answer is winning 2 to 1. Personally, I don’t use much Zetia- and will be stopping it in all of my patients.