Hypogonadal men aged 65 years and older experience significant benefit from testosterone replacement therapy (TRT) over 12 months, similar to what is observed in younger men, new findings suggest.
Using data from the Testim Registry in the U.S. (TRiUS), Rajib K. Bhattacharya, MD, of the University of Kansas Medical Center in Kansas City, and collaborators studied 845 registry participants with age information available at baseline. Of these, 133 (16%) were aged 65 and older. These men were similar to men younger than 65 years in the duration of hypogonadism prior to enrollment (a little over one year) and total testosterone (TT) and free testosterone (FT) levels at baseline.
At the 12-month follow-up, mean TT levels increased significantly from baseline in patients in both age groups, according to a report in Clinical Interventions in Aging (2012;7:321-330). The levels increased by 229.7 ng/dL from baseline to 524 ng/dL at 12 months in the older group and by 232.9 ng/dL to 491.1 ng/dL in the younger group. The differences between the groups were not significant. Mean FT levels increased significantly by 27.7 pg/mL from baseline to 65.5 pg/mL at 12 months in the younger group, but increased nonsignificantly by 15.4 pg/mL to 95.2 pg/mL in the older group. Notably, the researchers pointed out, the mean 12-month values did not differ significantly between the two groups.
After 12 months of TRT, PSA levels did not differ significantly between the groups.
In the study, most physicians prescribed either 50 mg testosterone gel (one five-gram tube) or 100 mg testosterone gel (two five-gram tubes) per day. No patient was prescribed more than 100 mg per day. Older patients were prescribed the lower dose significantly more often than the younger patients.
The study found associations between lower TT levels at baseline and the cardiovascular risk factors of greater weight, body mass index, waist and hip circumference, diastolic blood pressure, and plasma glucose levels, independent of age, according to the report.
Over the 12 months of the study, the increase in TT level was associated with decreased waist circumference and plasma glucose levels, and the increase in FT level was associated with decreased total and LDL cholesterol, independent of age.
Cardiovascular risk factors did not worsen during 12 months of TRT in the older patients, the authors noted.
Dr. Bhattacharya’s group pointed out that TRiUS was not specifically designed to assess safety, but adverse event reporting suggests that TRT was tolerated well in both age groups.