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15 April 2017

Is there a protective role of testosterone against high-grade prostate cancer?

Is there a protective role of testosterone against high-grade prostate cancer?

Historically, testosterone has almost been a synonym for prostate cancer, and therefore many men have been - and still are - denied testosterone therapy, despite having testosterone deficiency.

A rapidly growing number of studies have challenged the long-standing belief about a putative detrimental association between testosterone and prostate cancer development and/or progression. Here we present the results of a study published in The Aging Male, which investigated the incidence and severity of prostate cancer in testosterone treated versus non-testosterone treated patients who underwent prostate biopsy.

Key Points

  • Testosterone deficient men who receive testosterone therapy have a lower incidence of prostate cancer.
  • Testosterone therapy may protect against high-grade prostate cancer.
  • Both the development and progression of prostate cancer is lower in men who receive testosterone therapy, compared to untreated men.

15 December 2016

Testosterone treatment is not associated with risk of adverse cardiovascular events – RHYME study

Testosterone treatment is not associated with risk of adverse cardiovascular events – RHYME study

Testosterone treatment is not associated with increased risk of adverse cardiovascular events: results from the Registry of Hypogonadism in Men (RHYME). Maggi M, Wu FC, Jones TH, et al. Int J Clin Pract. 2016;70(10):843-852.

It is well-documented that testosterone therapy effectively restores testosterone levels in hypogonadal men and improves many health outcomes, such as quality of life, libido, metabolic parameters and body composition.

However, a few conflicting studies raised concerns about the cardiovascular safety of testosterone therapy which in 2015 prompted the FDA to issue warnings to physicians and patients about potential cardiovascular risks of testosterone therapy. In contrast, the European Medicines Agency (EMA) acknowledged the flaws of the conflicting studies and concluded that there is no consistent evidence of harm associated with testosterone therapy, regardless of mode of delivery.

Here we present the cardiovascular results of the notable RHYME (The Registry of Hypogonadism in Men) study, which contrary to prior clinical trials, enrolled patients with a wide range of comorbid illnesses and cardiovascular risk factors. The aim was to evaluate the safety of testosterone therapy in a sufficiently diverse population to reflect real-world, clinical experience.

Key Points

  • In comparison to both untreated men and to age-matched population data, no increase in mortality or cardiovascular risk was observed with testosterone therapy, regardless of:
    • The type of testosterone administered (injectable vs. topical preparations).
    • Presence of other comorbidities.
    • Age of patients (no increased risk was seen in both younger and older hypogonadal men).
    • The type of hypogonadism being treated (primary vs. secondary).
  • These results strongly support the overall cardiovascular safety of testosterone therapy.
  • The RHYME study refutes FDA’s labelling caution for potential risks of deep vein thrombosis with testosterone therapy.

15 December 2015

Testosterone Replacement Therapy and Mortality in Older Men

Testosterone Replacement Therapy and Mortality in Older Men

Hackett GI. Testosterone Replacement Therapy and Mortality in Older Men.
Drug Saf. 2016;39(2):117-130.

Despite a large prevalence of hypogonadism and increased testosterone prescribing over the past decade, large studies report that only 10-12% of hypogonadal patients (comprising 40-45% of studied populations) are receiving treatment.

One important reason for the under-treatment of men with testosterone deficiency is the widespread misperception about testosterone therapy on risk of cardiovascular disease. In this editorial we summarize a review paper published in the medical journal Drug Safety, which addresses the effects of testosterone therapy on cardiovascular risk factors, as well as mortality.

15 November 2015

Effects of Testosterone Administration for 3 Years on Subclinical Atherosclerosis Progression in Older Men

Effects of Testosterone Administration for 3 Years on Subclinical Atherosclerosis Progression in Older Men

Effects of Testosterone Administration for 3 Years on Subclinical Atherosclerosis Progression in Older Men With Low or Low-Normal Testosterone Levels: A Randomized Clinical Trial.
Basaria S, Harman SM, Travison TG, et al. JAMA. 2015;314(6):570-581.

Currently there are only a few high quality studies investigating the effects of testosterone therapy for a duration of 3 years and medical societies have long been urging for more long-term studies evaluating the safety and efficacy of testosterone therapy.

On August 11th 2015 a notable 3-year long RCT was published in JAMA (Journal of the American Medical Association), which attracted a lot of Attention. While interpreted by many as showing that testosterone therapy does not confer any benefits on atherosclerosis, sexual function and quality of life, a closer look at the data actually does show two important findings…

1 June 2015

Testosterone Therapy and Cardiovascular Risk - Advances and Controversies

Testosterone Therapy and Cardiovascular Risk  - Advances and Controversies

Morgentaler A, Miner MM, Caliber M, Guay AT, Khera M, Traish AM.
Testosterone therapy and cardiovascular risk: advances and controversies.
Mayo Clin. Proc. 2015;90(2):224-251.

One of the most debated issues related to testosterone therapy is its effects on cardiovascular risk, such as heart attack and stroke. This editorial summarizes key conclusions from a special review article written by the Androgen Study Group and published in Mayo Clinic Proceedings.



Key Points

  • Low levels of total, bioavailable, and free testosterone are associated with increased risk of development of cardiovascular risk factors, atherosclerosis and mortality.
  • Testosterone therapy has beneficial effects on a wide range of risk factors and risk biomarkers related to these clinical conditions.

1 February 2015

Adherence to testosterone therapy

Adherence to testosterone therapy

Long-term treatment patterns of testosterone replacement medications.
Donatucci C, Cui Z, Fang Y, Muram D. The journal of sexual medicine. Aug 2014;11(8):2092-2099.

Medication adherence and treatment patterns for hypogonadal patients treated with topical testosterone therapy: a retrospective medical claims analysis.
Schoenfeld MJ, Shortridge E, Cui Z, Muram D. The journal of sexual medicine. May 2013;10(5):1401-1409.

Testosterone therapy confers a wide range of health benefits for hypogonadal men, including improvements in body composition (reduction in body fat, increase in muscle mass, weight loss), lipid profile, cardiovascular function, insulin sensitivity/glucose metabolism, bone mineral density, inflammatory parameters, quality of life and potentially longevity.

Despite this, there is a high discontinuation rate with testosterone therapy. This editorial presents findings from two studies which have investigated adherence to testosterone therapy and treatment patterns.

1 January 2015

Testosterone-boosting Medications and Cardiovascular Risk

Testosterone-boosting Medications and Cardiovascular Risk

- a systematic review and meta-analysis

Cardiovascular risk associated with testosterone-boosting medications: a systematic review and meta-analysis. Corona G, Maseroli E, Rastrelli G, et al. Expert opinion on drug safety. Oct 2014;13(10):1327-1351.

Accumulating evidence shows beneficial effects of testosterone therapy on a wide range of health outcomes, including inflammation, insulin sensitivity, muscle mass, body fat mass, lipid profiles, endothelial (blood vessel) function, bone mineral density, energy and vitality, mood, sexual function and overall quality of life. Despite this, concerns have been raised that testosterone therapy could have detrimental effects on cardiovascular disease.

This editorial summarizes results from a comprehensive systematic review and meta-analysis, the largest to date, of all placebo-controlled randomized clinical trials (RCTs) on the effect of testosterone therapy on cardiovascular-related problems.


Last updated: 2019
G.MKT.GM.MH.02.2018.0506