Abstract and Introduction
Recent data suggest an increased risk of cardiovascular events and mortality in men on testosterone therapy (TT). To date, there are no long-term, prospective studies to determine safety. In such cases, retrospective observational studies can be helpful. We examined our patient database to determine whether TT altered the risk of all-cause mortality in men. We queried our hormone database for all men with a serum testosterone level and then examined charts to determine testosterone status. In all, 509 men had charts available for review. We linked our patient records to the National Death Index to determine mortality. Of the 509 men who met inclusion criteria, 284 were on TT and 225 did not use testosterone. Age (mean 54 years) and follow-up time (mean 10 years) were similar for both groups. In all, 19 men died—10 (4.4%) men not on TT and 9 (3.2%) men on TT. After adjusting for age and year of evaluation, there was no significant difference in the risk of death based on TT (hazard ratio 0.92, 95% confidence interval 0.36–2.35, P=1.0). There appears to be no change in mortality risk overall for men utilizing long-term testosterone therapy.
Low testosterone can negatively impact quality and quantity of life in men. Treatment of hypogonadism with testosterone therapy (TT) has been shown to improve muscle mass and strength, sexual function and desire, mood, bone mineral density and mortality. However, there remains concern about possible negative health effects of TT.
A recent randomized controlled trial of older men with hypogonadism and limited mobility demonstrated an increased risk of cardiovascular events when on testosterone compared with placebo. For this reason, the trial was stopped after ~9 months. However, a separate trial conducted using a similar patient population failed to demonstrate an impact on mortality after 6 months. Furthermore, a retrospective analysis of veterans affairs data identified a survival advantage for men on TT with up to 4 years of follow-up. In contrast, another retrospective study of veterans demonstrated a higher risk of mortality, myocardial infarctions and ischemic strokes while on TT. Recently, a retrospective study utilizing US claims data identified a higher risk of nonfatal myocardial infarction for men after initiating TT.
Given the heterogeneity in the literature and the uncertain applicability of previous findings to middle-aged men on TT, we sought to determine the impact on mortality of TT in men aged ≥40 years. By linking men treated with TT over the past 20 years with the National Death Index (NDI), we examined the association between mortality and TT.