Re: Do drugs {including statins} and procedures benefit women and men equally?

bigvince <Vince.Miraglia@xxxxxxxxx> wrote in part:

Heres the bottom line in the 4s study more women died in the treated
than placebo arm that fact just will not change and in the Heart
protection study no significant effect on mortality in women was
demonstrated. I believe the article referred to in Dr. Kendricks piece
was this one

BMJ 2003;327:933 (18 October), doi:10.1136/bmj.327.7420.933-b
excerptsImagine my delight when I heard of the large heart protection
study showing clear benefits in the use of statins for women.3 On
reading this study I was therefore disappointed to find the total
mortality data for women missing. I now understand that the total
mortality benefit for women did not reach significance and therefore
was not published (Louise Bowman, personal communication, 2002).

It was published in 2005, if not earlier. What you need to focus on is the
sex heterogeneity p-value of 0.8!

I do not understand why the censors of this paper do not realise two
things.

Firstly, any meta analyses based on this study are likely to be
skewed.

Secondly, in such long term studies total mortality, not improvement
in the condition, should be the gold standard for evaluation
(euthanasia, for example, provides 100% cure of headache but should be
ruled out on the mortality data). '

All-cause mortality is often the right measure. And the biggest controlled
trial (HPS) found a significant all-cause mortality benefit and a sex
heterogeneity p-value of 0.8.

There were not as many women as men in the study, and their risk levels for
dying were lower.

As it took over ten years for the HPS authors to even publish
mortality data by gender this study makes the case for open access to
data and this letter was written in the context of negative findings
also being beneficial.

Most of these folks work for their paychecks, Vince. I've published data
years after collecting it because it took that long to get funded to do the
analysis. But the results AREN'T NEGATIVE! p<0.8!!!

Thanks Vince

You're welcome.
--
Jim Chinnis Warrenton, Virginia, USA
.

Relevant Pages

  • Re: TNT study -- patients 65 and over
    ... It's pretty tough to show an all-cause mortality benefit ... reduction in all-cause mortality, ... There was a claim that TNT was underpowered to show a mortality benefit, ... There was also no trend toward mortality ...
    (sci.med.cardiology)
  • Re: TNT study -- patients 65 and over
    ... It's pretty tough to show an all-cause mortality benefit ... reduction in all-cause mortality, ... Jim is misremembering. ... There was a claim that TNT was underpowered to show a mortality benefit, ...
    (sci.med.cardiology)