For The Faint Of Heart: Lipitor
2 CommentsBy Ed Silverman // March 7th, 2007 // 10:58 am
Pfizer is doing its darndest to squeeze as much out of Lipitor as it can. This morning, the drugmaker released a laundry list of new indications for the blockbuster cholesterol pill, which loses US market exclusivity in 2011.
The indications: to reduce the risk of nonfatal heart attacks, fatal and non-fatal strokes, certain types of heart surgery, hospitalization for heart failure, and chest pain in patients with heart disease.
The approval, Pfizer says, is based on a five-year study involving 10,000 patients with both heart disease and elevated LDL levels. Patients given the 80 mg dose had a 22 percent reduction in the risk of major cardiovascular events compared with 10 mg. There was also a 26 percent reduction in the risk of hospitalization for heart failure.
There were more serious adverse events and discontinuations with 80 mg compared with 10 mg, Pfizer says, there was no difference in the overall frequency of the adverse events. The 10mg dose is, of course, more popular, but specific numbers would be helpful. Why weren’t these disclosed?
[tags]Lipitor, Pfizer[/tags]
M. Lewis
In reading your comment, you seem to imply that Pfizer is somehow hiding the adverse events data. While these data are not in the press release, it is worth noting that the data were previously published when the two studies were completed a year or two ago. Here’s a quote: “The reduction in cardiovascular risk associated with the 80-mg dose of atorvastatin was accomplished with an increase in the incidence of persistent elevations in liver-enzyme levels (1.2 percent, as compared with 0.2 percent in the group given 10 mg of atorvastatin; P
ed
Hi Morris,
To a degree, I am. Not that I assume anything untoward. But in my experience, companies are sometimes quick to tout preferential data while giving short shrift to such things as adverse events.
This is the sort of info that should be disclosed as a matter of course, simply to avoid the sort of discussion you and I are having (not that I mind chatting with you). It’s simply not practical, at the very least, to assume anyone can find data that was published in the past, simply because it was published. It’s best to just provide the info in the press release and be done with it.
In any event, thanks for passing this along.
Cheers
ed