In Reply: The preceding letters
raise 4 issues regarding the interpretation of AFCAPS/TexCAPS:
subgroups, the absence of conclusive mortality data,
cost-effectiveness, and noncardiovascular events.
Prespecified treatment by subgroup interactions were performed to
show consistency between the subgroups and the overall results, not to
establish efficacy within the subgroups. It is not statistically
appropriate to perform between-treatment comparisons within subgroups
(eg, women) when there is no interaction between the subgroup factor
and treatment, as was the case for sex and treatment in
AFCAPS/TexCAPS (ie, similar treatment effects for men and
women). However, if this test is performed, there is also inadequate
sample size to find a significant effect in women
(n=997, RR=0.54, 95% confidence
interval, 0.22-1.35). As AFCAPS/TexCAPS is the first primary
prevention study with a statin to include women, we considered it
important to report that treatment did not appear to work differently
or less effectively in women.