October 10, 2007. 11:26 p.m.
 Don't Start Crowing Yet Over WOSCOPS Follow-up Study.
 
Researchers of the West of Scotland Coronary Prevention Study (WOSCOPS)  
published a 15 year followup study of their patients who were  
originally randomized to the statin pravastatin versus placebo for five years.  
They reported a 25% reduction in coronary events and a statistically  
significant reduction in mortality. The original  
study was designed as a primary prevention study, although the authors  
stacked the deck in favor of positive results by including only men with  
high LDL cholesterol (>174) and with multiple risk factors, not the average  
guy who walks into the doctor's office. The original study reported a 2.2%  
reduction in heart attacks, which although statistically significant is  
not overwhelming. All cause mortality was 135 on placebo and 106 with pravastatin,  
which they reported as statistically non-significant in the  
original paper (correct me if I'm wrong) but in the current paper  
is re-reported as p value of 0.04 (what gives, guys?). They gave no  
report of CCK elevation, indicative of muscle damage, in which a three  
fold increase in dangerous elevations were seen in the original study  
with pravastatin. What is more concerning, there was a statistically  
significant increase in prostate cancer which went up as the years progressed;  
since most clinical trials last five years there is always the concern about  
long-term outcomes like cancer that can take years to progress.  
Prostate cancer developed in 89 on pravastatin versus 59 on placebo, a 51% increase,  
which is much greater than the 25% decrease in heart attacks.  
The authors stated that the increase was "probably due to  
chance and not causally related". A similar ruse was given for  
the finding from PROSPER of a 25% increase in cancer, where the  
authors said that it was due to "the play of chance". However, since  
a recent meta-analysis looking at all trials combined showed that high  
dose statins cause a statistically significant increases in cancer, I  
think it is time for these researchers to start playing by the  
rules of statistics, i.e. don't use statistics only when  
it goes in your favor.  
 

Doug Bremner, MD, is a physician
and researcher in Atlanta GA
and author of Before You Take That Pill:
Why the Drug Industry May be
Bad for Your Health

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