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23 November 2018

Lessons about Testosterone Therapy from the Testosterone Trials

Lessons about Testosterone Therapy from the Testosterone Trials

The Testosterone Trials show that testosterone therapy confers significant and clinically meaningful health benefits in older men with low testosterone levels. Even though the Testosterone Trials aimed to recruit men with hypogonadism due to no apparent reason other than age, in fact the majority of enrolled men were obese and more than one third had type 2 diabetes. Obesity, metabolic syndrome and/or type 2 diabetes are stronger risk factors for hypogonadism than aging per se. Consequently, the Testosterone Trials provide compelling evidence that testosterone therapy confers significant benefits in the growing population of men with obesity and/or type 2 diabetes. Furthermore, the Testosterone Trials confirm the safety in this patient population; the placebo group experienced more adverse events than the testosterone group.

An additional notable aspect of the Testosterone Trials is that they refute FDA’s position that testosterone therapy should only be given to men with classical hypogonadism (caused by pituitary injury/tumor, testicular damage or Klinefelter’s syndrome).

15 December 2017

Low Testosterone is Associated with Elevated Cardiovascular Disease Biomarkers

Low Testosterone is Associated with Elevated Cardiovascular Disease Biomarkers

Pastuszak AW, Kohn TP, Estis J, Lipshultz LI. Low Plasma Testosterone Is Associated With Elevated Cardiovascular Disease Biomarkers. The journal of sexual medicine. 2017;14(9):1095-1103.

The fear of increased risk of heart attack and stroke with testosterone therapy was mainly caused by two high profile but flawed studies. Even though many new studies have refuted these alleged cardiovascular risks and even demonstrated that testosterone therapy is associated with a reduced cardiovascular risk, concern still remains.

Other lines of research have also countered the alleged cardiovascular risks. For example it has been shown that declining testosterone levels in men can be a signal of deteriorating health, and men with testosterone deficiency hypogonadism) who remain untreated have an increased risk of heart attack and stroke. This is contrary to what the few flawed studies concluded. Furthermore, testosterone deficiency discovered during hospitalization (regardless of cause) is associated with in-hospital and long-term mortality in elderly male patients. Specifically, testosterone deficiency in hospitalized men has been significantly associated with a 3.3-fold increased risk of all-cause mortality and a 2.1-fold increased risk of cardiovascular mortality.

To get a better understanding of the relation between testosterone and cardiovascular health and disease, it is useful to look at studies that have investigated mechanisms underlying heart attack and stroke. Here we summarize the results of a study published in the Journal of Sexual Medicine. It examined the relation between testosterone levels and cardiovascular risk using a large panel of 10 objective biomarkers that have been linked to cardiovascular health.

Key Points

  • Cardiovascular biomarkers can be used as surrogate endpoints to evaluate treatment more efficiently and quickly than to wait for clinical events (hard endpoints) such as heart attacks and strokes to happen.
  • Low testosterone levels are associated with harmful elevations in 9 of 10 cardiovascular biomarkers: cardiac troponin I (cTnI), endothelin-1 (ET-1), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), N-terminal proB-type natriuretic peptide (NTproBNP), high-density lipoprotein (HDL) cholesterol, high-sensitivity C-reactive protein (hs-CRP), hemoglobin A1c (HbA1c), and leptin.
  • Previous studies have shown that testosterone treatment improves several cardiovascular biomarkers; CRP, interleukin-1beta, TNF-α, interleukin-1beta, and leptin.
  • The ability of testosterone treatment to improve leptin sensitivity is especially notable considering that leptin resistance may play a causative role in the metabolic decline seen with aging.

15 October 2017

UK policy statements on testosterone deficiency

UK policy statements on testosterone deficiency

Hackett G, Kirby M, Edwards D, Jones TH, Rees J, Muneer A. UK policy statements on testosterone deficiency. Int J Clin Pract. 2017;71(3-4).

Testosterone deficiency (also known as hypogonadism) and its treatment is a medical issue that has long been neglected, despite causing significant physiological and psychological health complications among affected men. Longstanding dogmatic fears about prostate cancer and more recent misleading studies alluding to heart attack and stroke risk, has made testosterone treatment a controversial topic.

Here we summarize the newly published UK policy statements on testosterone deficiency, which are based on an International expert consensus conference on testosterone deficiency and its treatment. These statements, developed by the British Society for Sexual Medicine, address widespread media and scientific concerns over the appropriate treatment of testosterone deficiency with testosterone therapy.

Key Points

British Society for Sexual Medicine (BSSM) policy statements on testosterone deficiency:
  1. Testosterone deficiency is a well-established, significant medical condition.
  2. Testosterone deficiency has well-established symptoms.
  3. Testosterone therapy for men with testosterone deficiency is effective, rational and evidence based.
  4. There is no scientific basis for withholding testosterone therapy from men on the basis of age.
  5. Testosterone deficiency is associated with increased cardiovascular and all-cause mortality.
  6. The evidence does not support an increased cardiovascular risk associated with testosterone therapy.
  7. There is no evidence that supports any increase in the risk of prostate cancer with testosterone replacement therapy.
  8. A major research initiative to explore the benefits of testosterone therapy in cardiometabolic disease is overdue.

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 February 2016

Effects of testosterone treatment in older men

Effects of testosterone treatment in older men

Medical research can be of varying quality. The double-blind randomized controlled trial (RCT) is accepted by medicine as the gold standard objective scientific methodology, and provides the highest strength of evidence for the effectiveness of a treatment. Growing research evidence shows that treating testosterone deficient men with testosterone therapy provides a number of wide-ranging benefits beyond mere relief of symptoms, including improvements in muscle mass, insulin sensitivity, fat mass (both total body fat and visceral fat), endothelial function, blood pressure, lipid profile and bone mineral density.

Recent clinical practice guidelines state that testosterone therapy is safe if treatment and monitoring are appropriately executed, and most of the available evidence does not support alleged concerns regarding risk of cardiovascular disease and prostate cancer. Despite this, opponents state that the clinical benefits and potential long-term risks of testosterone therapy have not been adequately assessed in large RCTs, and that therefore a general policy of testosterone replacement in all older men with age-related decline in testosterone levels is not justified.

To address the lack of large RCTs on testosterone therapy, the US National Institute of Health has funded The Testosterone Trials, which is a coordinated set of 7 large double-blind RCTs. Here we report the first results from The Testosterone Trials.

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.


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