
Testosterone replacement therapy (TRT) was more effective at correcting existing anemia and preventing the development of new anemia in men aged 45 to 80 years with hypogonadism compared with placebo, according to a randomized controlled trial published in JAMA Network Open.
This analysis, led by Karol M Pencina, PhD, of the Brigham and Women’s Hospital at Harvard Medical School in Boston, was nested in the TRAVERSE study that evaluated the impact of TRT on major adverse cardiovascular events in middle-aged and older men with hypogonadism.
Testosterone Replacement Therapy Corrects Anemia and Prevents Development
Patients eligible for enrollment in TRAVERSE were middle-aged or older and had two testosterone concentration measurements <300 ng/dL, symptoms of hypogonadism, and cardiovascular disease (CVD) or increased CVD risk.
Between May 2018 and February 2022, 5,204 men were enrolled in TRAVERSE across 316 centers in the United States. Participants were stratified based on pre-existing CVD and randomized to 1.62% testosterone gel or placebo gel daily. The primary outcome was proportion of patients with anemia, defined as hemoglobin <12.7 g/dL, who achieved remission. The secondary endpoint was incident anemia in previously non-anemic patients.
Of the 5,204 men with hypogonadism, 814 had anemia and 4,379 did not. The anemia cohort had a mean age of 64.8 ± 7.7 years and was 30.3% Black (n=247), 66.7% White (n=544), and 2.9% other (n=24). The nonanemia cohort had a mean age of 63.0 ± 7.9 years and was 14.4% Black (n=629), 82.3% White (n=3,603), and 3.4% other (n=147).
Dr. Pencina and colleagues reported that significantly more patients treated with TRT achieved anemia compared with placebo-treated patients at each of the following time points (P=.002).
Treatment | Six months | 12 months | 24 months | 36 months | 48 months |
TRT | 143 of 349 (41.0%) | 152 of 338 (45.0%) | 124 of 290 (42.8%) | 94 of 216 (43.5%) | 41 of 92 (44.6%) |
Placebo | 103 of 375 (27.5%) | 122 of 360 (33.9%) | 95 of 307 (30.9%) | 76 of 229 (33.2%) | 38 of 97 (39.2%) |
The proportion of patients without anemia who developed new anemia was significantly smaller in the TRT group compared with the placebo group, researchers stated. They added that changes in hemoglobin levels were associated with changes in energy levels.
In short, “In middle-aged and older men with hypogonadism and anemia, TRT was more efficacious than placebo in correcting anemia,” and “TRT was also associated with a reduced incidence of anemia among men without anemia at baseline.”
Reference
Pencina KM, Travison TG, Artz AS, et al. Efficacy of testosterone replacement therapy in correcting anemia in men with hypogonadism: a randomized clinical trial. JAMA Netw Open. 2023;6(10):e2340030. Published 2023 Oct 2. doi:10.1001/jamanetworkopen.2023.40030