Testosterone and Aging Clinical Research Directions (2004) / Chapter Skim
Currently Skimming:
4 Concluding Remarks
4 Concluding Remarks
Pages 159-164
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From page 159... ...
Collecting such evidence can take many years, with knowledge gained through iterative and incremental steps. Experience with the use of postmenopausal hormone therapy in women and the growing body of scientific evidence about its risks and potential benefits provides an apt and timely example of the need for sustained, systematic analysis of short- and long-term effects of new treatments and the caution that must be exercised in widely prescribing drugs as preventive measures.
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From page 160... ...
In the case of postmenopausal hormone therapy, a substantial body of observational data existed on indicated potential benefits, such as reduced risk of cardiovascular outcomes, and there was a rapid rise in the use of hormone products from the 1970s through the 1990s (OTA, 1992~. Only recently have the results from clinical trials (such as WHI)
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From page 161... ...
CLINICAL STUDIES IN MIDDLE-AGED MEN As a final point, although the focus of this report is on testosterone therapy in older men, the committee realized that the large and growing population of middle-aged men using testosterone products also raises important public health concerns about the benefits and risks in this age group. The motivation for younger men in using testosterone therapy appears to have relatively little to do with increased bone mineral density and decreased fracture risk, but it is mainly sought to improve strength, body image, sexual function, and vitality.
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From page 162... ...
In particular, information about the age-specific rate of initiation and duration of use of testosterone therapy, as well as how this changes with calendar time, would provide a valuable basis for assessing the possible health impacts of long-term testosterone administration. Other options could include incorporating questions about testosterone use into existing largescale studies of middle-aged men or adding measures of testosterone levels as one of the secondary outcome measures to future research efforts, thereby gaining useful data with relatively minimal expense, particularly as compared to a large-scale clinical trial.
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From page 163... ...
Journal of the American Medical Association 289~20~:2663-2672. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J
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From page 164... ...
Efficacy trials of testosterone therapy must be fielded to assess potential benefits, particularly in the older male population, which is more likely to exhibit low testosterone levels and experience symptoms that could benefit from treatment. These smaller more focused trials may additionally provide important information regarding dose regimen and delivery methods as well as inform decisions regarding study power for potential long-term studies.
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