Monday, November 17, 2014

Merck Meets Primary Endpoint In IMPROVE-IT -- Full Results At Noon

No way to know the magnitude of the effect, yet. UPDATED: Only a small effect, but positive -- barely statistically significant, or more. . . robust?

Press releases embargoed until 11:45 EST. More then. UPDATE: Larry Husten, over at Forbes, is on it!

. . . .The benefit wasn’t very big or impressive but it will be enough to put to rest concerns that ezetimibe might have been an expensive placebo. . . .

The investigators calculated that 50 patients would need to be treated for seven years to prevent one event. There was no difference between the groups in overall deaths, coronary deaths, or cardiovascular deaths, but there were significant reductions in MI (13%, p =0.002), stroke (14%, p=0.052), and ischemic stroke (21%, p=0.008). . . .

UPDATED: So I think the question becomes. . . is the added cost of higher priced combo pills worth the above effect? That's a debate for the ages.

As reported by Larry, Dr. Steve Nissen (long skeptical of Vytorin's cost to benefit ratio) said that while the trial result was trustworthy, and that the trial was well conducted -- the modest effect left him wondering “when have you ever seen a risk reduction as small as 6%?” He noted that the trial was powered to detect a 9% difference but got only a 6% reduction. Said another way, you'd need to treat 350 patients for a year to see one avoided MI event. Smallish, indeed.

Stay warm and healthy, one and all. Noon: Merck common stock is rising, but only a fraction of a per cent, on moderately light volume on the NYSE -- which confirms the above -- not a world beater.

No comments: