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May 8, 2002

Sildenafil and Physical Exertion in Men With Coronary Artery Disease

JAMA. 2002;287(18):2359-2360. doi:10.1001/jama.287.18.2359

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.