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Long-Term Testosterone Shows Cardiovascular Safety in Men With Testosterone Deficiency in Electronic Health Records.

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Long-term testosterone therapy (TTh) in men with testosterone deficiency (TD) showed no increased cardiovascular risk in real-world practice. This study found TTh did not elevate major adverse cardiovascular events (MACE) and improved hyperlipidemia markers.

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Area of Science:

  • Endocrinology
  • Cardiology
  • Real-world evidence

Background:

  • Testosterone deficiency (TD) affects numerous men, with testosterone therapy (TTh) being a common treatment.
  • Concerns exist regarding the cardiovascular (CV) safety of long-term TTh.
  • Real-world data is crucial to understand the CV implications of TTh in diverse patient populations.

Purpose of the Study:

  • To evaluate the association between long-term TTh and CV safety in men diagnosed with TD.
  • To assess the risk of major adverse cardiovascular events (MACE) in men receiving TTh compared to those not receiving it.
  • To investigate the impact of TTh on the development and progression of diabetes and hyperlipidemia.

Main Methods:

  • Retrospective analysis of electronic health records from 2683 adult men with TD across three healthcare systems (2012-2023).
  • Propensity score matching created a 1:1 ratio of TTh (928 patients) and non-TTh (928 patients) groups, balanced for age, race, Charlson Comorbidity Index, and baseline testosterone levels.
  • Intent-to-treat analysis using Kaplan-Meier curves and Cox regressions assessed MACE, diabetes, and hyperlipidemia outcomes over a median 3-year follow-up.

Main Results:

  • The cumulative incidence of MACE was comparable between TTh and non-TTh groups (P > .05).
  • No statistically significant association was found between TTh use and increased CV risk (univariate HR: 1.01 [0.75-1.36]; adjusted HRs: 0.98 [0.72-1.32] and 0.93 [0.68-1.26]).
  • TTh was not associated with incident diabetes but showed significant improvements in low-density lipoprotein and total cholesterol levels in patients with hyperlipidemia.

Conclusions:

  • Real-world clinical practice indicates that TTh in men with TD is not linked to an elevated risk of cardiovascular events.
  • Testosterone therapy demonstrates a neutral effect on major adverse cardiovascular events.
  • TTh may offer benefits for lipid profiles in men with hyperlipidemia and TD.