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ACP releases treatment guidelines for age-related low testosterone
The ACP released clinical guidance for testosterone treatment in men with age-related low testosterone, recommending treatment only for those experiencing sexual dysfunction. The guideline was published in the Annals of Internal Medicine.
“Testosterone use in the United States has tripled in recent years and many times it is prescribed to manage nonspecific symptoms,” Amir Qaseem, MD, PhD, lead author of the clinical guideline and vice president of clinical policy at ACP, told Healio Primary Care. “There has been a lot of direct to consumer advertising showing benefits of testosterone treatment in aging men.”
The use of testosterone treatment for age-related low testosterone is controversial, according to Qaseem and colleagues. Currently, the FDA requires testosterone products to include a warning to inform consumers of a potentially increased risk for stroke and heart attack.
Review on efficacy and safety
Researchers conducted a systematic review of 38 randomized control trials that lasted at least 6 months and assessed transdermal or intramuscular testosterone therapies compared with placebo or no treatment. Twenty observational studies, FDA review data and product labels were also evaluated in the review.
The reviewed studies included primarily older men with varied ages, symptoms and testosterone eligibility criteria.
Susan J. Diem, MD, MPH, a staff physician in the Minneapolis VA Health Care System, and one of the study’s researchers, told Healio Primary Care that they found “testosterone treatment in men with age-related low testosterone may result in modest improvements in sexual function but does not generally result in improvements in other symptoms, such as fatigue, reduced physical function, or cognitive concerns. Use for those symptoms is unlikely to have benefit.”
In addition, the researchers found no differences in outcomes between intramuscular or transdermal testosterone formulations. They also did not find adequate evidence to determine long-term benefits or harms from testosterone treatment.
“Given the lack of long-term data on efficacy and safety of testosterone therapy in men with age-related low testosterone, clinicians should re-evaluate symptoms and health status periodically and reassess appropriateness of continuing testosterone treatment,” Diem, who is also an associate professor of medicine at the University of Minnesota School of Medicine, explained.
Clinical guideline recommendations
The ACP issued a conditional recommendation for clinicians to discuss the benefits, harms, costs and preferences of testosterone treatment with their male patients who have age-related low testosterone and want to improve their sexual function.
After initiating treatment, the organization recommends that clinicians reevaluate patients within the first 12 months and periodically thereafter. Treatment should be discontinued in patients who do not demonstrate an improvement in sexual function.
As the clinical harms and effectiveness of both reviewed formulations were similar, the guideline recommends that clinicians consider intramuscular treatment, which costs $156.32 per patient per year over transdermal formulations, which cost $2,135.32 per person per year.
Finally, the organization recommends against the use of testosterone therapy to improve energy, vitality, physical function or cognition in men with age-related low testosterone.
“We do not know the harms of these medications such as cardiovascular events, prostate cancer, thromboembolic disease or death, especially of long-term treatment,” Qaseem said.
The guidelines do not address screening, diagnosing hypogonadism or monitoring testosterone levels.
Potential reactions to guidelines
In a related editorial, E. Victor Adlin, MD, of the Lewis Katz School of Medicine at Temple University, wrote that while the guidelines correspond with recommendations from other organizations, the suggestion for physicians to consider intramuscular over transdermal formulations will be questioned by physicians.
He explained that although the lower cost of intramuscular preparations is a plus, the need for an injection every 1 to 4 weeks could be a barrier to treatment adherence and potentially lead to additional expenses from recurrent visits to a health care facility.
In addition, blood levels of testosterone after each injection could cause irregular symptom relief and lead to difficulty in achieving the desired blood level of testosterone.
“The decision to initiate testosterone therapy for age-related low testosterone should depend on a discussion between the patient and a well-informed caregiver, with full consideration of the patient's values and wishes,” he wrote. – by Erin Michael
References:
Adlin EV, et al. Ann Intern Med. 2020;doi:10.7326/M19-3815.
Diem SJ, et al. Ann Intern Med. 2020;doi:10.7326/M19-0830.
Qaseem A, et al. Ann Intern Med. 2020;doi:10.7326/M19-0882.
Disclosures: Adlin and Qaseem report no relevant financial disclosures. Diem reports grants from the National Institute on Aging outside the submitted work. Please see studies for all other authors’ relevant financial disclosures.