Background
Increases in testosterone prescribing without accompanying changes in proven medical indications or diagnosis of pathological androgen deficiency have been documented in Australia (Handelsman, MJA, 2010).
Data from the USA have recently been published that support the Australian data and again raise questions about marketing and promotion of testosterone to men as a cure-all for a variety of ailments, particularly to ageing men with declining testosterone levels.
This US paper was accompanied by an article (Braun, 2013) describing the conflict of interest issues around drug company sponsorship of ‘consensus panels’, continuing medical education and development of patient materials related to testosterone.
A related commentary (Schwartz & Woloshin, 2013) discusses the so-called “Low T” disease awareness campaign and the techniques used to lead men to think their symptoms are due to low testosterone and can be treated with testosterone therapy.
Aim
To examine androgen prescribing patterns in the United States over 10 years (2001-2011).
Methods
Data from a large US commercial health insurance population was used to examine androgen prescribing patterns over 10 years.
Prevalence of use was calculated as the number of men receiving a prescription for androgen replacement therapy (ART) in one year divided by the number of men covered in that year.
Incident users were men prescribed ART who had not received a prescription in the 12 months prior. Total days of ART in the 12 months following the first prescription for androgen comprised an incidence cohort from 2010.
Total days represented all filled prescriptions and number of days covered by prescription.
Results
During 2001-2011 a total of 10,739,815 men aged 40 years or older were included in the overall study population, with a minimum of 1,270,812 men in any year.
From 2001 through 2011, androgen use among men 40 years or older increased more than 3-fold, from 0.8% in 2001 to 2.9% in 2011. In 2011 2.3% of men in their 40s and 3.8% of men in their 60s were taking ART with topical gel preparations used the most and also showing the greatest increase over time.
Among all new androgen users (2001-2011), only 35.9% had testosterone level measured in the previous 12 months.
Common diagnoses in the year prior to ART initiation were hypogonadism (50.6%), fatigue (34.5%), erectile dysfunction (31.9%), psychosexual dysfunction (11.8%).
Conclusion
The authors concluded that the finding that most men did not have clear evidence of an indication for ART suggests that the clinical reasons for initiating therapy are complex and more research is needed to determine the extent to which men with normal testosterone levels and ambiguous symptoms seek and are prescribed ART.