madman
Super Moderator
Purpose of review
The incidence of testosterone deficiency and the number of men on testosterone therapy (TTh) has increased significantly over the past 3 decades. This rise has been accompanied by controversies surrounding the indications and possible adverse effects of therapy. To better inform prescribing habits among providers, many major medical associations have devised guidelines regarding the diagnosis and management of testosterone deficiency. While these guidelines agree in many areas, there are some key differences that should be identified. This review will explore the similarities, differences, and rationale for these guidelines.
Recent findings
Over the past 7 years, much attention has been devoted to the implications of TTh on cardiac health. All reviewed guidelines include dedicated sections discussing these implications and the society’s position on prescribing testosterone considering recent findings, however, differ on specific contraindications to TTh and when to initiate therapy after a cardiovascular event. In addition, the American College of Physicians released its first guideline earlier this year which may impact prescribing habits among primary care physicians.
Summary
The differences between testosterone deficiency guidelines may indicate gaps in our knowledge of testosterone deficiency and the focus of future research efforts. Prescribers should be aware of these differences and discuss all treatment options with their patients.
INTRODUCTION
Testosterone deficiency (also known as male hypogonadism) is a clinical syndrome characterized by low serum levels of circulating testosterone in addition to one or more associated symptoms. The estimated prevalence of testosterone deficiency worldwide ranges from 2 to 10% and increases with age and the presence of comorbidities [1–4,5& ]. The introduction of improved testosterone formulations in the 1990s led to a four-fold rise in new testosterone prescriptions and a 10-fold increase in market share during the early-2000s, although prescriptions sharply declined after 2013 following the publication of divisive studies suggesting an association with adverse cardiovascular events [6,7& ]. These findings prompted the Food and Drug Administration (FDA) to mandate the inclusion of a warning on all testosterone packaging cautioning of the potential cardiovascular risks of prescription testosterone in 2014. In 2016, another FDA warning was added to alert prescribers of the potential for testosterone abuse and associated adverse outcomes. Due to these controversies and the high rate of off-label testosterone prescriptions, testosterone therapy (TTh) remains contentious [8]. To improve consistency in prescribing habits among providers, multiple major medical associations have released guidelines for the diagnosis and treatment of testosterone deficiency. This review will compare the recommendations from these guidelines and discuss the rationale behind their similarities and differences.
CONCLUSION
Due to the increased recognition of testosterone deficiency as a clinical entity and the rise of testosterone prescriptions over the past 3 decades, professional organizations have sought to codify available evidence into practice guidelines. Although many of these guidelines share similar key recommendations for approaching testosterone deficiency, there are some notable differences, especially regarding diagnosis, follow-up schedules, and treatment of special populations. As an example, a man with a history of MI 5 months ago may be a candidate for TTh based on the EAU and ISSM guidelines, but the AUA and Endocrine Society specifically recommends against TTh in this patient. Similar discrepancies exist for infertile patients or those with a history of PCa. The reasons for this variability may be attributed to the time of publication, the composition of the committee, local prescribing habits, or differences in available T formulations (e.g., in Europe versus North America). Importantly, disagreement among the guidelines highlights the need for well-designed randomized trials to inform the best clinical practices in the management of testosterone deficiency. When results of studies such as TRAVERSE are published in the coming decade, perhaps more congruent guidelines will also result.
The incidence of testosterone deficiency and the number of men on testosterone therapy (TTh) has increased significantly over the past 3 decades. This rise has been accompanied by controversies surrounding the indications and possible adverse effects of therapy. To better inform prescribing habits among providers, many major medical associations have devised guidelines regarding the diagnosis and management of testosterone deficiency. While these guidelines agree in many areas, there are some key differences that should be identified. This review will explore the similarities, differences, and rationale for these guidelines.
Recent findings
Over the past 7 years, much attention has been devoted to the implications of TTh on cardiac health. All reviewed guidelines include dedicated sections discussing these implications and the society’s position on prescribing testosterone considering recent findings, however, differ on specific contraindications to TTh and when to initiate therapy after a cardiovascular event. In addition, the American College of Physicians released its first guideline earlier this year which may impact prescribing habits among primary care physicians.
Summary
The differences between testosterone deficiency guidelines may indicate gaps in our knowledge of testosterone deficiency and the focus of future research efforts. Prescribers should be aware of these differences and discuss all treatment options with their patients.
INTRODUCTION
Testosterone deficiency (also known as male hypogonadism) is a clinical syndrome characterized by low serum levels of circulating testosterone in addition to one or more associated symptoms. The estimated prevalence of testosterone deficiency worldwide ranges from 2 to 10% and increases with age and the presence of comorbidities [1–4,5& ]. The introduction of improved testosterone formulations in the 1990s led to a four-fold rise in new testosterone prescriptions and a 10-fold increase in market share during the early-2000s, although prescriptions sharply declined after 2013 following the publication of divisive studies suggesting an association with adverse cardiovascular events [6,7& ]. These findings prompted the Food and Drug Administration (FDA) to mandate the inclusion of a warning on all testosterone packaging cautioning of the potential cardiovascular risks of prescription testosterone in 2014. In 2016, another FDA warning was added to alert prescribers of the potential for testosterone abuse and associated adverse outcomes. Due to these controversies and the high rate of off-label testosterone prescriptions, testosterone therapy (TTh) remains contentious [8]. To improve consistency in prescribing habits among providers, multiple major medical associations have released guidelines for the diagnosis and treatment of testosterone deficiency. This review will compare the recommendations from these guidelines and discuss the rationale behind their similarities and differences.
CONCLUSION
Due to the increased recognition of testosterone deficiency as a clinical entity and the rise of testosterone prescriptions over the past 3 decades, professional organizations have sought to codify available evidence into practice guidelines. Although many of these guidelines share similar key recommendations for approaching testosterone deficiency, there are some notable differences, especially regarding diagnosis, follow-up schedules, and treatment of special populations. As an example, a man with a history of MI 5 months ago may be a candidate for TTh based on the EAU and ISSM guidelines, but the AUA and Endocrine Society specifically recommends against TTh in this patient. Similar discrepancies exist for infertile patients or those with a history of PCa. The reasons for this variability may be attributed to the time of publication, the composition of the committee, local prescribing habits, or differences in available T formulations (e.g., in Europe versus North America). Importantly, disagreement among the guidelines highlights the need for well-designed randomized trials to inform the best clinical practices in the management of testosterone deficiency. When results of studies such as TRAVERSE are published in the coming decade, perhaps more congruent guidelines will also result.