Advertising hormone replacement therapies
There has been a fair amount of direct-to-consumer advertising for manufacturers of testosterone replacement therapies on the benefits of testosterone replacement. These ads foster the idea that age and a decline in sexual hormones (testosterone in men, estrogen in women after menopause) may contribute significantly to health issues such as:
- general well-being
Sexual health issues such as libido and erectile function have significantly contributed to an interest in these therapies.
Estrogen replacement therapy for women
With estrogen replacement therapy for women, it was thought that the therapy might not only affect women’s well-being and an improvement in menopausal symptoms such as hot flashing, but might also have significant benefits on bone strength and cardiovascular health. Unfortunately, the opposite has been shown. Use of estrogen or hormone replacement therapy (HRT) has been shown to increase cardiovascular risk and may also increase the risk of breast malignancy. These therapies are no longer recommended.
Testosterone replacement therapy for men – “Been there; done that.”
There have been two recent studies which have raised concerns about the safety of these testosterone replacement therapies for men. A Veterans Affairs study published in November of 2013 showed that the risk of death, heart attack or stroke was higher in men who received testosterone compared to men who were not treated with these therapies. There was a 5.8% absolute risk increase in these problems in the men who received testosterone. *
What does that mean? Every 17 men who are treated with testosterone would have one of these unfortunate outcomes.
A second study in June of 2014 of over 50,000 men showed the incidence of heart attack at 90 days after initially being treated with testosterone replacement therapies being significantly higher for heart attack risk. The authors of this study did an interesting comparison looking at whether use of drugs for treatment of erectile dysfunction like Viagra, Cialis or Levitra caused any increased hazard. There was no significant increased risk. **
Both of these studies have been criticized by physician and industry supporters of testosterone therapy because these studies were what is called “observational studies.” These studies do not strictly control the differences between the treated group and the group that does not receive the treatment. The FDA and others have called for randomized control trials to assess the definite safety and efficacy of testosterone replacement.
The Endocrine Society and American Association of Clinical Endocrinologists have included a testosterone therapy recommendation in the recently published “Choosing Wisely” guideline.
The statement on this issue is:
Don’t prescribe testosterone therapy unless there is biochemical evidence of testosterone deficiency.
Many of the symptoms attributed to male hypogonadism are commonly seen in normal male aging or in the presence of comorbid conditions. Testosterone therapy has the potential for serious side effects and represents a significant expense. It is therefore important to confirm the clinical suspicion of hypogonadism with biochemical testing (measurement of blood levels of testosterone). Current guidelines recommend the use of a total testosterone level obtained in the morning. A low level should be confirmed on a different day, again measuring the total testosterone. In some situations, a free or bioavailable testosterone may be of additional value.
The current consensus appears to be that we should clearly avoid testosterone replacement therapies in older patients, frail patients or patients who have definite coronary disease. In addition, use of testosterone replacement should be carefully guided with laboratory testing for other hazards.
In my practice, I have now recently seen two men less than age 60 on testosterone replacement therapy who had heart attacks. The linkage is suspicious since the patient did not have other significant coronary risk factors.
Caution is strongly recommended with this treatment until more information is known about its safety and efficacy.
* Vigen R, O’Donnell CI, Barón AE, et al. JAMA. 2013;310(17):1829-36.
** Finkle WD, Greenland S, Ridgeway GK, et al. PLoS One. 2014;9(1):e85805.