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[Testosterone replacement therapy and cardiovascular risk].

Giovanni Corona1, Mauro Dicuio2, Giulia Rastrelli3

  • 1Unità di Endocrinologia, Ospedale Maggiore, Dipartimento Medico, Azienda USL di Bologna, Bologna.

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|November 7, 2017
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Summary
This summary is machine-generated.

Testosterone therapy (TTh) safely treats late onset hypogonadism (LOH) symptoms in men with low testosterone. Evidence shows TTh improves sexual function, and controlled trials do not support increased cardiovascular risk.

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Area of Science:

  • Endocrinology
  • Men's Health
  • Aging Research

Background:

  • Late onset hypogonadism (LOH) is characterized by age-dependent testosterone reduction.
  • Sexual dysfunction is a primary symptom driving medical consultation for LOH.

Purpose of the Study:

  • To review conflicting data on the clinical significance and cardiovascular risks of testosterone therapy (TTh) in LOH.
  • To analyze evidence supporting differing FDA and EMA positions on TTh safety.

Main Methods:

  • Analysis of population-based studies and randomized controlled trials (RCTs) on LOH and TTh.
  • Review of regulatory statements from the US Food and Drug Administration (FDA) and European Medicines Association (EMA).

Main Results:

  • TTh improves all aspects of sexual function compared to placebo.
  • Controlled trials do not substantiate increased cardiovascular risk with TTh, particularly concerning major adverse events.

Conclusions:

  • Symptomatic men with confirmed low testosterone can be safely treated with TTh.
  • Conflicting regulatory stances on TTh cardiovascular risk warrant careful consideration of trial data.