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Testosterone Replacement Therapy

Long-Term Testosterone Therapy Improves Cardiometabolic Function and Reduces Risk of Cardiovascular Disease: Real-Life Results

 
Most men with testosterone deficiency need testosterone therapy for the rest of their life in order to achieve and maintain best possible health outcomes. Therefore, studies that investigate the effects of testosterone therapy in real-life are needed, to shed light on adherence and health outcomes in routine clinical practice.[1] While randomized controlled trials (RCTs) are gold standard in medical research [2, 3], RCTs are conducted in highly controlled environments and therefore their results may not carry over to the uncontrolled setting of real-life.[1] It is increasingly recognized that conclusions drawn from RCTs are not always a useful aid for decision-making because evaluating the value of a drug or technology requires an understanding of its impact on current clinical practice and management of patients in a real-life setting.[4]
 
A series of “real-life studies” have been conducted, all showing numerous health benefits of testosterone therapy in testosterone deficient (hypogonadal) men and confirming its safety, with an observation period of up to 17 years.[5-23] Here I summarize the results from the most recent real-life study, published February 9th 2017 in the Journal of Cardiovascular Pharmacology and Therapeutics which investigated the long-term effects and safety of testosterone therapy for up to 8 years in testosterone deficient men attending a urological office.[5] Differences in cardiovascular risk factors and deaths with testosterone therapy were compared to those seen in testosterone deficient men not receiving testosterone therapy but attending the same urological office.[5] 
 
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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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Testosterone Therapy in Men with Prostate Cancer – Yes or No?

Historically, prostate cancer – both active and treated - has been an absolute contraindication to testosterone therapy and – from a regulatory perspective – still is. The incidence of prostate cancer is higher in older men, in whom prostate cancer accounts for one in five new cancer diagnoses.[1]
 
Thanks to improvement in early detection and treatment of prostate cancer, prostate cancer mortality has decreased 50% during the past two decades, and more men are living with a history of prostate cancer. 
 
The aging of the male population and the increasing number of prostate cancer survivors have resulted in a significant increase in the number of men presenting with hypogonadism and treated prostate cancer. Therefore, it is important to consider the growing number of recent studies which have challenged the long-standing belief that prostate cancer is an absolute contraindication to testosterone therapy.[2-4]
 
Here I summarize the results of a notable study which investigated the effects of testosterone therapy in men with treated and untreated prostate cancer [5], and conclude with the latest recommendations on managing testosterone deficiency in men with history of prostate cancer.
 
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How is anabolic steroid use different from testosterone replacement therapy?

One main reason testosterone replacement therapy is surrounded by controversy is that testosterone is abused, both in athletic populations but also in the general public.[1] Scientific evidence is undisputed that testosterone are extremely potent in increasing muscle growth and enhancing physical performance.[1-3]
 
The ethical issue of fair play in sports, coupled with the well-known adverse health effects of supra-physiological doses of anabolic steroids [4-14], has given medically legit testosterone replacement therapy (aka TRT, testosterone therapy or testosterone treatment) a bad reputation and is depriving many suffering men with testosterone deficiency from receiving medically needed testosterone treatment.[15] 
 
In this article I will point out the salient differences between use testosterone replacement therapy – a.k.a. testosterone therapy or testosterone treatment - and abuse of anabolic steroids, and explain why testosterone treatment - which per definition is medically provided and supervised - has no parallel with abuse of anabolic steroids.
 
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Dispelling the myth of testosterone treatment and prostate cancer

Fear of prostate cancer remains one of the major concerns with testosterone therapy among doctors, and reason to deny suffering hypogonadal men testosterone treatment.[1, 2]
 
This fear persists despite mounting research over the past decade that has clearly refuted the belief that testosterone therapy increased risk of prostate cancer among men in the general population.[3-5]
 
Aside prostate cancer, benign prostatic hyperplasia (BPH) with its associated lower urinary tract symptoms (LUTS) are also common concerns with testosterone therapy.[6]
 
In this article I summarize and comment on the results of the Registry of Hypogonadism in Men (RHYME) study; a large, multi-national prospective registry of men with testosterone deficiency, which was designed and powered specifically to assess prostate cancer outcomes in hypogonadal men receiving testosterone therapy compared with untreated hypogonadal men or general population estimates.[7]- 
 
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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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Video Summary: Testosterone Deficiency and Treatment - International Expert Consensus Resolutions

In a previous article "Testosterone Deficiency and Treatment - the FACTS" I presented the conclusions from an International Expert Consensus Conference on Testosterone Deficiency and Its Treatment.[1]
 
Here I summarize the key points, and link to a video summary by Dr. Abraham Morgentaler, an internationally renowned testosterone scientist and clinician.
 
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Testosterone Deficiency and Treatment - the FACTS

Testosterone deficiency and treatment is a very misunderstood and controversial topic among scientists, regulatory agencies (such as the FDA and EMA) and doctors, as well as the popular media.
 
On October 1, 2015, an international expert consensus conference about testosterone deficiency and its treatment was held in Prague, sponsored by King’s College London and the International Society for the Study of the Aging Male (ISSAM). The impetus for this meeting was to address the widespread misinformation and confusion about testosterone deficiency and testosterone therapy.[1]
 
The ultimate goal of this consensus conference was to document what is true or untrue about testosterone deficiency and testosterone therapy, to the best degree possible based on existing scientific and clinical evidence.
 
There were 18 experts from 11 countries on 4 continents. Specialties included urology, endocrinology, internal medicine, diabetology, and basic science research. Experts were invited on the basis of extensive clinical experience with testosterone deficiency and its treatment and/or research experience.
 
The final consensus on several key issues related to testosterone therapy was published in the form of 9 resolutions (i.e. firm decisions), coupled with expert comments.[2] These are summarized in table 1.
 
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Real-life experience of continuous long-term testosterone therapy on anthropometric, endocrine and metabolic parameters for up to 10 years

While it is well documented that testosterone levels decline in aging men, recent studies show that in some cases obesity and impaired general health can be more influential causes of testosterone deficiency than chronological age and aging per se.[1, 2]
 
Here I present real-life results from a registry study which investigated the effects of continuous long-term testosterone therapy for up to 10 years on anthropometric (body measurements), endocrine and metabolic parameters in obese hypogonadal men.[3]
 
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Survival and cardiovascular events in men on testosterone treatment

On the surface, testosterone therapy is a controversial treatment because previous studies investigating the effects of testosterone therapy have been conflicting, with some studies showing supposed harm and others showing significant benefit.
 
Here I summarize the results of a new study published in The Lancet Diabetes & Endocrinology on May 7 2016, which addressed some shortcomings in previous studies by analyzing effects based on duration of testosterone treatment.[1]
 
 
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