Safety of Testosterone Therapy in Older Men

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Nelson Vergel

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Safety of T Therapy in Older Men

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The use of T therapies in older men has been limited by concerns over adverse cardiovascular and prostatic effects. Several meta-analyses suggest T has been well-tolerated in the majority of studies in healthy older men. [SUP][141],[142],[143][/SUP] The most frequent adverse effect seen is increased hematocrit, which may lead to clinically significant erthrocytosis. [SUP][141],[142],[143][/SUP] T has also been shown to be well-tolerated in frailer older men, with only mild effects on hematocrit, prostate specific antigen (PSA) and blood lipids. [SUP][114][/SUP] In contrast to these findings, the TOM trial of T therapy in men with limited mobility was discontinued following an imbalance in cardiovascular events in T treated men compared to placebo. [SUP][127][/SUP]This discrepancy may be explained by the relatively high dose used in a comparatively high risk population: the strongest risk factor for cardiovascular events in this trial was the increase in free T. [SUP][144][/SUP] This is consistent with previous findings of greater frequencies of adverse events associated with higher T doses in healthy older men. [SUP][8][/SUP] Men included in the trial had a high mean BMI, as well as a very high frequency of hypertension, diabetes and hyperlipidemia. [SUP][127][/SUP] This experience sounds a salutary note of caution regarding the safety of treating frail elderly men with relatively high doses of T, highlighting the importance of careful patient or trial subject selection.

The effects of T on serious prostate events are currently unclear due to the relatively small size of the studies and short duration of exposure. A 2005 meta-analysis suggested that men treated with T experienced approximately double the rate of all prostate events including biopsies, cancers, increased symptoms, increments in PSA and urinary retention. [SUP][141][/SUP]However, this may be explained by monitoring bias. [SUP][141][/SUP] The effects of T on prostate and cardiovascular events will only be clearly established by larger scale, longer duration, appropriately powered clinical trials.

http://www.ajandrology.com/preprintarticle.asp?id=122581
 
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