Northwest Institute for Healthy Sexuality on the use of Testosterone Replacement in Men

As a specialty care clinic dedicated to the effective and safe treatment of individuals with sexual dysfunction and men’s health overall, the Northwest Institute for Healthy Sexuality (NWIHS) is aware of concerns in 2013 and 2014 regarding cardiovascular risks associated with the use of testosterone therapy. NWIHS has followed closely the recent media attention regarding the FDA’s stated intent to review cardiovascular risk with this treatment in men with hypogonadism, and recognizes that there is also contradictory evidence suggesting a beneficial influence of testosterone therapy on cardiovascular risk. Definitive studies have not been performed and are expected to be ongoing in the coming years.

Definition of testosterone deficiency

Testosterone deficiency (also called hypogonadism) is a medical condition that has been recognized for over a century, associated with such symptoms as reduced sexual desire, erectile dysfunction, fatigue, depressed mood, reduced muscle mass, and increased fat. Research has shown that T deficiency is also associated with a number of significant health issues, such as diabetes, obesity, the metabolic syndrome, and bone fractures. Several longitudinal population-based studies have demonstrated reduced longevity in men with low T levels. Treatment of T deficiency improves symptoms as well as several indicators of general health. Testosterone therapy is only indicated in men with characteristic symptoms or signs as well as documented low testosterone levels.

The NWIHS advocates for thorough and appropriate medical work-up to identify primary or secondary hypogonadism in men who complain of symptoms suggestive of testosterone deficiency, which is catered individually to each man, but commonly includes two separate draws of total testosterone, sex hormone binding globulin, and calculated free testosterone, as well as LH, FSH, prolactin, PSA, and hematocrit in addition to a thorough physical exam and medical interview. The NWIHS is committed to providing state of the art treatment recommendations for men that are appropriate candidates for testosterone replacement. The NWIHS does not encourage testosterone replacement to men who do not meet symptomatic and medical diagnostic criteria for testosterone deficiency, or to men who seek testosterone treatment for body building or performance enhancement.

The NWIHS acknowledges many of the symptoms of testosterone deficiency are non-specific and may be multifactorial in origin. Hence, symptoms may not be necessarily linked to hypogonadism alone. Men who complain of fatigue, depression, reduced erectile function, and diminished interest in sex may also receive comprehensive and multi-disciplinary medical recommendations to address these symptoms if testosterone values are determined to be unrelated to these complaints, including attention to insomnia, obesity, diabetes, cardiovascular disease, thyroid disorders, mood disorders, relationship quality, and high life stress among many others.

The NWIHS advocates for informed consent for all men seeking testosterone replacement. Potential adverse effects of testosterone therapy including acne, breast swelling or tenderness, increased red blood cell count, swelling of the feet or ankles, reduced testicular size and infertility, will be discussed prior to treatment. Current evidence does not provide any definitive answers regarding the risks of testosterone therapy on prostate cancer and cardiovascular disease, however, the historical concern that T therapy promotes prostate cancer appears to be unfounded and currently testosterone replacement is not considered to increase the risk of cardiovascular events. Evidence to date will be reviewed.

Cardiovascular Risk of Testosterone Replacement

Recent concern of adverse cardiovascular events with testosterone replacement stems from two journal articles, one published in November 2013 in the Journal of the American Medical Association, and the other published in January 2014 in the journal, Plos One. Neither of these reports was a planned experimental study with control groups and defined goals, rather they were retrospective analyses of data collected for other reasons. These types of analyses are prone to bias and error, and results are often irreproducible. For this reason, this type of study is generally not used for medical decision-making, although in some cases these may prompt further investigation with an experimental study.

Review of both studies reveals major flaws that render questionable the assertion that testosterone therapy increases cardiovascular (CV) risks. The suggestion of increased cardiovascular risk with these recent reports is contradicted by a large body of literature that strongly indicates CV risks in association with low testosterone levels, and beneficial effects of T therapy in improving risk factors for CV disease. Although an objective scientific approach must openly consider all new evidence, the NWIHS does not find these new reports to provide credible evidence of increased CV risk with T therapy.

Follow up care for Testosterone Replacement

The NWIHS endorses optimal follow-up of men on testosterone therapy to include measurement of testosterone levels, SHBG, calculated free testosterone, PSA and hematocrit. Other patient-specific measures may be appropriate, especially in men with metabolic syndrome or cardiovascular disease co-morbid conditions.

The NWIHS recognizes and encourages the need for increased educational awareness of the benefits and risks of testosterone therapy among both patients and health care providers, and is dedicated to collaborate where needed with a man’s team care of providers including primary care providers, endocrinologists, urologists, and cardiologists to achieve optimal care and clinical results.

Recommendations

The NWIHS advocates for clinically rigorous, evidence based, and holistic management of men with testosterone deficiency. In light of recent concerns regarding cardiovascular risk and testosterone therapy, the NWIHS finds there is no reason to change the current management of men with testosterone deficiency on the basis of these recent articles, but does encourage attention to cardiovascular risk parameters such as hyperlipidemia, hypertension, and diabetic glycemic control.

Hypogonadal men who present with concomitant elevation in PSA levels will be advised on the correlation of testosterone therapy and prostate health, and will be encouraged to collaborate care with a urology provider at Washington Urology & Urogynecology Associates PLCC. Men currently being treated for testosterone deficiency with testosterone therapy and experiencing benefits may continue treatment. Men diagnosed with testosterone deficiency should consider treatment with testosterone therapy after full discussion with the medical staff at the NWIHS. Testosterone therapy provides significant benefits for men with sexual symptoms, and also for a variety of non-sexual symptoms. Like all medical treatments, testosterone therapy is associated with risks, and these will be discussed. Weighing the entirety of available medical research, there is no compelling evidence that testosterone therapy increases cardiovascular risk.