To the Editor: Because the study by Arruda-Olson
and colleagues1 could only "assess the effects
of sildenafil on the extent and severity of ischemia," the overall risk of
sildenafil among men with stable CAD remains uncertain. For instance, summary
measures used to address questions of efficacy for groups may be inadequate
when safety issues for individuals are addressed.2
Means and SDs, particularly when large numbers of patients are studied, tend
to obscure the response of outliers, ie, patients who indeed are affected
by interventions. Although in this study the mean responses between groups
were not different, it is possible that some patients could have been negatively
affected by sildenafil without exhibiting clinical signs and that such episodes
were missed by the manner in which the data were reported. Indeed, 1 patient
receiving the drug experienced fainting, a well-known hemodynamic effect associated
with sildenafil.3 In contrast, no subject
fainted when receiving placebo.
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