Efficacy and safety of injectable testosterone undecanoate (Aveed or Nebido) for the treatment of hypogonadism

Since its approval in 2004, many clinical studies have been conducted with testosterone undecanoate, the first long-acting injectable form of testosterone.
 
Testosterone undecanoate has been proven to have an excellent safety profile and need only be administered four times annually to produce stable testosterone levels.[1]
 
Long-term studies have validated the clinical efficacy of testosterone undecanoate in maintaining stable therapeutic levels of testosterone and safely conferring the desired benefits of androgen replacement.[1]
 
Here I summarize the results from a comprehensive meta-analysis of all uncontrolled and placebo-controlled randomized clinical trials (RCTs) demonstrating the effect of injectable testosterone undecanoate on multiple clinical outcomes.[2]
 
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Testosterone Boosting Medications and Cardiovascular Risk - a systematic review and meta-analysis

Accumulating evidence shows beneficial effect of testosterone therapy on a wide range of health outcomes, including inflammation, insulin sensitivity, muscle mass, body fat mass, lipid profiles,  endothelial, bone mineral density, energy and vitality, mood, sexual function and overall quality of life. [1-9]
 
Despite this, concerns have been raised that testosterone therapy could have detrimental effects on cardiovascular disease.
 
In this article I summarize 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 outcomes.[10] 
 
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How well informed are general practitioners and cardiologists about testosterone deficiency and its consequences?

A rapidly growing body of medical research is showing that testosterone deficiency (aka hypogonadism and low-T) is strongly associated with a wide range of detrimental health outcomes [1, 2], and that testosterone replacement therapy improves those health parameters that are negatively affected by testosterone deficiency.[2, 3]
 
Therefore, leading testosterone scientists now view testosterone deficiency as a cardiovascular risk factor that contributes to the development of cardiovascular disease.[4-7]
 
As general practitioners and cardiologists primarily care for these patients with cardiovascular disease, a survey study was conducted to assess their knowledge, beliefs and clinical practice with respect to testosterone deficiency and cardiovascular health.[8]
 
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Testosterone Therapy and Cardiovascular Risk - Advances and Controversies

One of the most debated issues related to testosterone therapy is its effects on cardiovascular risk and clinical events, like for example heart attack.
 
January 27th, 2015 a comprehensive medical review paper was published, addressing the controversial topic of testosterone therapy and cardiovascular risk.[65] It was written by the Androgen Study Group academicians and published in Mayo Clinic Proceedings.
 
Here I summarizes key conclusions from this milestone medical review.
 
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Long-term testosterone treatment with different testosterone preparations - provocative results on diagnosis and adherence

Due to lack of consistent clear-cut guidelines for diagnosis and treatment of testosterone deficiency, there is a lot of confusion among both health professionals and suffering men. The multiple different testosterone preparations available further add to the complexity of testosterone treatment.

This article presents the intriguing results from a notable study that analyzed effects of testosterone therapy with seven different testosterone preparations in symptomatic men who had previously been denied treatment because of “normal” baseline testosterone levels.[1]
 
The results are quite provocative and highlight several important practical issues relating to diagnosis and treatment of hypogonadism…
 
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Waist-to-Height Ratio as a Screening Tool for Testosterone Deficiency

A bidirectional relationship exists between excess body fat, and/or belly fat, and testosterone levels in men. That is, excess body (belly) fat decreases testosterone levels and may cause testosterone deficiency, and low testosterone levels increases body (belly) fat.[1-4]  I covered this in-depth in a previous article “Testosterone and Fat Loss - the Evidence”.
 
In “Keep your waist to less than half your height” I introduced the waist-to-height ratio and explained that it is a better tool for predicting health outcomes and mortality than is waist circumference alone. I have also covered the association between a large waist (i.e. belly) and reduced testosterone levels in "Young Men, Waist, Testosterone and Erectile Function: Low-T is not only an old man's issue".
 
Here I will summarize research showing that the waist-to-height ratio can also be used as a screening tool for testosterone deficiency. 
 
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Testosterone treatment is NOT associated with risk of adverse cardiovascular events – the RHYME study

It is well-documented that testosterone therapy effectively restores testosterone levels in hypogonadal men and improves many health outcomes, such as quality of life [1-4], libido [4, 5], metabolic parameters [5-9] and body composition.[4, 5, 9, 10]
 
However, a few conflicting studies raised concerns about the cardiovascular safety of testosterone therapy [11, 12], 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.[13]
 
Here I summarize the cardiovascular results of the notable RHYME (The Registry of Hypogonadism in Men) study, which contrary to prior clinical trials, enrolled men with a wide range of comorbid illnesses and cardiovascular risk factors.[14] The aim was to evaluate the safety of testosterone therapy in a sufficiently diverse population to reflect real-world, clinical experience.[14]
 
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Dr. Pierce's Medical Organization Affiliations

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