FDA recommendation for treatment based on underlying cause considered unclear.
On March 3, 2015, the FDA held a hearing and released a drug safety communication statement cautioning clinicians on the use of testosterone replacement therapy (TRT) in men unless low testosterone levels have been confirmed and to alert patients of the possible increased cardiovascular risks. The American Association of Clinical Endocrinologists (AACE) has issued a position statement to the FDA’s announcement emphasizing the potential benefits.
The AACE argues that the FDA recommendation for the use of TRT in only men with disorders of the testicles, pituitary gland, or brain that cause hypogonadism is unclear. In their opinion, they believe that every patient who is considered for TRT should undergo a thorough diagnostic workup, and that therapy decision should be guided by the signs/symptoms and testosterone concentration rather than the underlying cause. They believe that it should not be used to relieve symptoms in men who have low testosterone for no reasons other than old aging.
The AACE also points out that there has been epidemiologic studies that associate TRT with favorable outcome changed in cardiovascular risk factors such as: reducing fat mass, increasing muscle mass, and decreasing insulin resistance. The AACE also acknowledges that the randomized, controlled studies have not been adequately aimed to characterize the relationship between TRT and cardiovascular risks. The committee notes that all these studies are flawed, precluding meaningful conclusions. They call for a large-scale prospective randomized trial to better analyze the risks.
Although there have been recent studies relating testosterone treatment to an increase in cardiovascular disease, there is no compelling evidence that it does. Both the FDA and the AACE agree that a large-scale prospective randomized controlled trial focused on the cardiovascular risks with testosterone therapy are needed. In clinical setting, it’s recommended that clinicians rely on common sense, experience, and an individualized treatment approach.
- There have been some concerns with increased CVD risks associated with the use of TRT.
- Unlike the FDA, the AACE believes that patients should be treated based on their signs/symptoms rather than the underlying cause.
- Both the FDA and AACE agree that larger-scale prospective randomized trials are in need to better assists these risks.
“American Association of Clinical Endocrinologists Position Statement on the Association of Testosterone and Cardiovascular Risk.” Endocrine Practice 21.9 (2015):1066. Journals. Web. 1 Oct.2015.