Abstract
tio [HR], 1.26; 95% CI, 1.18-1.35), hospitalization (HR, 1.16; 95% CI, 1.13-1.19), and death (HR, 1.34; 95% CI, 1.15-1.56) compared with testosterone gel or patch formulations. The outcomes of the analysis support the hypothesis that intermittent pharmacologic levels of testosterone, which are inevitable with an injectable depo-testosterone administration every 2 to 3 weeks, result in an association with an increase in the combined outcome of cardiovascular and cerebrovascular morbidity and death. The absolute risk between testosterone therapy groups was small in this epidemiologic analysis, but the risk does raise concern considering the marked increase in testosterone prescriptions both in the United States and internationally 5 and prior associations in large data sets of increased risks in men receiving vs those not receiving treatment. 3,4 In addition, Layton and colleagues 1 did not include a comparison group of men not receiving testosterone, so overall risks and benefits of the therapy cannot be compared between the groups. Layton et al 1 acknowledge the limitations of the study, including lack of information concerning the indication for treatment and only partial data concerning testosterone levels before initiating or during therapy. However, their findings are consistent with those of other large epidemiologic studies 3,4 and the recent alarming US Food and Drug Administration report that more than 25% of testosterone prescriptions in the United States are written without determination of a level and that more than 30% of patients receiving testosterone therapy do not have follow-up laboratory testing. 5 Taken together, these
Published Version
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