Abstract
BackgroundAn association between testosterone therapy (TT) and cardiovascular disease has been reported and TT use is increasing rapidly.MethodsWe conducted a cohort study of the risk of acute non-fatal myocardial infarction (MI) following an initial TT prescription (N = 55,593) in a large health-care database. We compared the incidence rate of MI in the 90 days following the initial prescription (post-prescription interval) with the rate in the one year prior to the initial prescription (pre-prescription interval) (post/pre). We also compared post/pre rates in a cohort of men prescribed phosphodiesterase type 5 inhibitors (PDE5I; sildenafil or tadalafil, N = 167,279), and compared TT prescription post/pre rates with the PDE5I post/pre rates, adjusting for potential confounders using doubly robust estimation.ResultsIn all subjects, the post/pre-prescription rate ratio (RR) for TT prescription was 1.36 (1.03, 1.81). In men aged 65 years and older, the RR was 2.19 (1.27, 3.77) for TT prescription and 1.15 (0.83, 1.59) for PDE5I, and the ratio of the rate ratios (RRR) for TT prescription relative to PDE5I was 1.90 (1.04, 3.49). The RR for TT prescription increased with age from 0.95 (0.54, 1.67) for men under age 55 years to 3.43 (1.54, 7.56) for those aged ≥75 years (ptrend = 0.03), while no trend was seen for PDE5I (ptrend = 0.18). In men under age 65 years, excess risk was confined to those with a prior history of heart disease, with RRs of 2.90 (1.49, 5.62) for TT prescription and 1.40 (0.91, 2.14) for PDE5I, and a RRR of 2.07 (1.05, 4.11).DiscussionIn older men, and in younger men with pre-existing diagnosed heart disease, the risk of MI following initiation of TT prescription is substantially increased.
Highlights
Testosterone therapy (TT) has been used in healthy older men to treat diminished extremity strength and physical function associated an age-related decline in serum testosterone. [1] Recently testosterone therapy (TT) has been increasing extraordinarily rapidly, including among younger men and among those without hormone measurement, suggesting that the indications for prescription have likely markedly expanded. [2,3] Three recent studies have raised some concerns about possible adverse cardiovascular outcomes associated with TT
We examined the rate ratio (RR) for phosphodiesterase type 5 inhibitors (PDE5I) and compared the RRs in the TT prescription and PDE5I cohorts
Statistical Methods We examined the effect of the medications by estimating the ratio of the myocardial infarction (MI) incidence rate in the post-prescription interval to the MI incidence rate in the pre-prescription interval
Summary
Testosterone therapy (TT) has been used in healthy older men to treat diminished extremity strength and physical function associated an age-related decline in serum testosterone. [1] Recently TT has been increasing extraordinarily rapidly, including among younger men and among those without hormone measurement, suggesting that the indications for prescription have likely markedly expanded. [2,3] Three recent studies have raised some concerns about possible adverse cardiovascular outcomes associated with TT. [4] This was followed by a meta-analysis of a number of a number of very small trials in predominantly older men which suggested excess cardiovascular risk. For other factors, the point estimates of risks were divergent among the studies, with hazard ratios ranging from less than 1.3 to greater than 5.0. All of these studies recognized the importance of evaluating risk among those men with and without preexisting heart disease, but did not have sufficient numbers of subjects to adequately assess this issue. An association between testosterone therapy (TT) and cardiovascular disease has been reported and TT use is increasing rapidly
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