Monday, August 14, 2006

Pfizer - Lipitor: 80mg a secondary stroke preventer?

Hold the presses. The media has been full of it.

The New England Journal of Medicine has published a study examining the effect of Lipitor on strokes and transient ischaemic attacks (TIAs).

The study recruited approximately 4,700 patients who had experienced a stroke between 1 and 6 months prior to randomisation to receive either atorvastatin 80mg or placebo. Follow up was for 5 years and data were collected on fatal and non-fatal stroke, TIAs, cardiovascular events and deaths.

Statistically, there were fewer strokes in the Lipitor arm of the study with a reported absolute risk reduction of 2.2%.

So, treat 45 such people for five years and one stroke is prevented.

But there was no difference in overall mortality between the groups.

There was also an increased risk of haemorrhagic stroke in the Lipitor arm.

Journal Watch has appraised the study and noted that the study just achieved statistical significance.

Since this is the first study to directly examine the effects of statins on strokes they concluded that it is unclear “whether an 80-mg dose of atorvastatin is necessary to achieve secondary prevention of stroke”.

Hat tip: Prescribing Advice for GPs

1 comment:

Anonymous said...

It seems likely, to me, that this study was conducted with an eye toward generic competition in the form of simvastatin. Pfizer knew Merck was their largest competitor in the statin market, and conducted this study in the hopes of finding this correlation at around this time.


In the last month, I've seen Express Scripts (one of the largest pharmacy PBMs) move toward making Lipitor available only with a Prior Authorization where before it was the preferred statin of choice. Several other PBMs have done the same thing.

The only exception in the case of Express? 80mg Lipitor. I think that's why Pfizer is emphasizing the "80mg" part as much as the "Lipitor" part: the strength is just as significant (for them) as the drug itself.

My experience is anecdotal in this case -- and should be taken as such -- but there it is nonetheless.