New guidelines on testosterone diagnosis and deficiency released

New guidelines on testosterone diagnosis and deficiency released

In recent years, there has been concern on the use of testosterone therapy.  Many men have been receiving therapy who do not need it while men who do need it and would benefit from it, are not receiving the therapy. Another concern is that sometimes patients placed on testosterone therapy are not always being monitored properly.

This is why the American Urological Association, a leading global urology association, announced that it has released new clinical guidelines on the diagnosis and treatment of testosterone deficiency.

A panel of experts conducted a systematic review of 546 articles published from 1980 to February 2017 that helped support the new guideline statements. The strength of the evidence for each statement was graded A (high) to C (low).  In the absence of sufficient evidence, the panel offered information as Clinical Principles and Expert Opinions.

Testosterone is a vital hormone produced by the testicles and is essential for a variety of male physical, cognitive, sexual, and metabolic functions.  It is natural for testosterone levels to decrease as a man ages since their ability to produce the hormone declines.  This decline of testosterone is about 1-3 percent per year starting after the age of 40.  However, this natural decline does not imply a man is automatically testosterone deficient or a candidate for testosterone therapy. 

Testosterone deficiency is not defined simply as a state of low testosterone production.  The true definition is when a man has a state of low testosterone production combined with low testosterone symptoms such as low libido, erectile dysfunction, loss of energy, reduced muscle mass or bone density, and fatigue.  When a man meets both criteria of low testosterone production and symptoms of low testosterone, then he is considered testosterone deficient and is considered a candidate for testosterone therapy. 

One concern of starting testosterone therapy is the possibility of increasing a man’s risk for cardiovascular events, which is still unclear.  Because of the lack of clarity, the panel suggested not to start testosterone therapy in patients with a history of cardiovascular disease.

It is highly recommended that PSA levels should be measured in men older than 40 years before starting testosterone therapy to exclude a prostate cancer diagnosis.  At this time, there is insufficient evidence to weight the benefits and risks of testosterone therapy in men with prostate cancer even though evidence has not confirmed a link between testosterone therapy and prostate cancer development. 

Following is the listing of the new guidelines for the diagnosis and treatment of testosterone deficiency:

Diagnosis of testosterone deficiency:

Clinicians should measure total testosterone more than once and obtain a symptom history before making a diagnosis. Validated questionnaires are not sufficient for either diagnosis or monitoring. 

According to the guidelines: 

·    Clinicians should use a total testosterone level below 300 ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone. (Moderate Recommendation; Evidence Level: Grade B)

·    The diagnosis of low testosterone should be made only after two total testosterone measurements are taken on separate occasions with both conducted in an early morning fashion. (Strong Recommendation; Evidence Level: Grade A)

·    The clinical diagnosis of testosterone deficiency is only made when patients have  low total testosterone levels combined with symptoms and/or signs.(Moderate Recommendation; Evidence Level: Grade B)

·    Clinicians should consider measuring total testosterone in patients with a history of unexplained anemia, bone density loss, diabetes, exposure to chemotherapy, exposure to testicular radiation, HIV/AIDS, chronic narcotic use, male infertility, pituitary dysfunction, and chronic corticosteroid use even in the absence of symptoms or signs associated with testosterone deficiency. (Moderate Recommendation; Evidence Level: Grade B)

Adjunctive Testing

·    In patients with low testosterone, clinicians should measure serum luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)

·    Serum prolactin levels should be measured in patients with low testosterone levels combined with low or low/normal luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)

·    Patients with persistently high prolactin levels of unknown etiology should undergo evaluation for endocrine disorders. (Strong Recommendation; Evidence Level: Grade A)

·    Prior to offering testosterone therapy, clinicians should measure hemoglobin and hematocrit and inform patients regarding the increased risk for polycythemia. (Strong Recommendation; Evidence Level: Grade A)

·    Clinicians should inform testosterone deficient patients that low testosterone is a risk factor for cardiovascular disease. (Strong Recommendation; Evidence Level: Grade B)

·    Patients should be informed that testosterone therapy may result in improvements in erectile function, low sex drive, anemia, bone mineral density, lean body mass, and/or depressive symptoms. (Moderate Recommendation; Evidence Level: Grade B)

·    Patients should be informed that the evidence is inconclusive whether testosterone therapy improves cognitive function, measures of diabetes, energy, fatigue, lipid profiles, and quality of life measures. (Moderate Recommendation; Evidence Level: Grade B)

Treatment of Testosterone Deficiency: Treatment should target therapeutic testosterone levels and ease symptoms.

·    Clinicians should adjust testosterone therapy dosing to achieve a total testosterone level in the middle tertile of the normal reference range. (Conditional Recommendation; Evidence Level: Grade C)

·    Clinicians should not prescribe alkylated oral testosterone. (Moderate Recommendation; Evidence Level: Grade B)

·    Clinicians should discuss the risk of transference with patients using testosterone gels/creams. (Strong Recommendation; Evidence Level: Grade A)

Follow-up of Men on Testosterone Therapy

·    Testosterone levels should be measured every 6 to 12 months while on testosterone therapy. (Expert Opinion)

·    Clinicians should discuss the cessation of testosterone therapy 3 to 6 months after commencement of treatment in patients who experience normalization of total testosterone levels but fail to achieve symptom or sign improvement. (Clinical Principle) 

The full guideline is available online at: http://www.AUAnet.org/TestosteroneGuideline