Issue: February 2024
Fact checked byRichard Smith

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November 13, 2023
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Testosterone treatment boosts hemoglobin levels for older men with anemia

Issue: February 2024
Fact checked byRichard Smith
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Key takeaways:

  • Men with anemia were more likely to have correction of their condition with testosterone therapy vs. placebo.
  • Fewer men receiving testosterone developed anemia during the study compared with placebo.

Testosterone therapy increases hemoglobin levels for older men with anemia and is linked to a lower likelihood for developing anemia for men without the condition, according to study data.

As Healio previously reported, the TRAVERSE trial randomly assigned 5,204 men aged 45 to 80 years with at least one symptom of hypogonadism, two fasting serum testosterone levels of less than 300 ng/dL and preexisting cardiovascular disease or elevated CV risk to transdermal 1.62% testosterone gel (AbbVie) or matching placebo gel. Researchers conducting the FDA-mandated trial found that men receiving testosterone gel had a similar rate of CV events as those receiving placebo. In a nested study within the TRAVERSE trial, researchers found testosterone therapy also confers benefits for men with anemia.

Testosterone replacement leads to anemia correction for 45% of men at 12 months.
Data were derived from Pencina KM, et al. JAMA Netw Open. 2023;doi:10.1001/jamanetworkopen.2023.40030.

“Anemia is a common health problem among older men that is associated with fatigue, functional limitations, a reduced ability to carry out activities of daily living, increased risk of falls, exacerbation of existing CVD and increased risk of hospitalizations and mortality,” Shalender Bhasin, MD, professor of medicine at Harvard Medical School, director of the research program in Men’s Health: Aging and Metabolism and director of the Boston Claude D. Pepper Older Americans Independence Center at Brigham and Women’s Hospital, and colleagues wrote in a study published in JAMA Network Open. “Testosterone deficiency is often an overlooked cause of anemia in older men. The TRAVERSE Anemia study provides evidence that testosterone replacement therapy was significantly more efficacious than placebo in correcting anemia in middle-aged and older men with hypogonadism.”

Testosterone therapy corrects anemia

In the TRAVERSE trial, there were 815 men who had anemia with a hemoglobin level of less than 12.7 g/dL at baseline (mean age, 64.8 years; 66.7% white), with 390 of those men randomly assigned to testosterone therapy and 425 receiving placebo. Researchers examined the percentage of men with anemia who had correction of anemia with an increase in hemoglobin to 12.7 g/dL or higher during the study. Among the 4,379 men who did not have anemia at baseline (mean age, 63 years; 82.3% white), researchers assessed the risk for developing amenia during the study and the percentage of men who had a hemoglobin increase of more than 1 g/dL. Complete blood counts and blood chemistry were measured at baseline, 6 months, 12 months and then annually through 48 months.

Shalender Bhasin

Among men with anemia at baseline, a higher proportion of participants receiving testosterone had anemia correction compared with placebo at 6 months (41% vs. 27.5%), 12 months (45% vs. 33.9%), 24 months (42.8% vs. 30.9%), 36 months (43.5% vs. 33.2%) and 48 months (44.6% vs. 39.2%). The testosterone group had a higher proportion of men with a hemoglobin increase of more than 1 g/dL than the placebo group at all timepoints. Hemoglobin levels increased more in the testosterone group vs. placebo at all visits.

Fewer men receiving testosterone develop anemia

Among men without anemia at baseline, a small percentage of those receiving testosterone developed anemia compared with placebo at 6 months (7.2% vs. 10.4%), 12 months (7.1% vs. 9%), 24 months (10% vs. 12.3%), 36 months (10% vs. 12.9%) and 48 months (9% vs. 10.2%). Hemoglobin levels increased more in men without anemia receiving testosterone compared with placebo at all visits.

Red cell count and hematocrit levels increased more in men receiving testosterone compared with placebo, regardless of whether they had anemia at baseline. Among men without anemia at baseline, mean corpuscular volume and mean corpuscular hemoglobin decreased more in the testosterone group vs. placebo. No changes in mean corpuscular volume and mean corpuscular hemoglobin were observed for men with anemia in either group.

Adverse events occurred among men with anemia at a similar frequency to what was observed in the overall TRAVERSE trial. There were trends toward more nonfatal cardiac arrythmias and acute kidney injury for men receiving testosterone who had anemia at baseline.

“The TRAVERSE Anemia study’s findings of testosterone’s efficacy in correcting anemia and in preventing the development of anemia will facilitate a more informed appraisal by clinicians and patients of the potential benefits and risk of testosterone replacement therapy in middle-aged and older men with hypogonadism in whom testosterone replacement therapy is being considered,” the researchers wrote.