Testosterone replacement for men 'trade-off with risks'

T Trials researchers had to screen more than 50,000 men to find 788 with confirmed abnormally low testosterone levels along with one or more age-related symptom that the hormone might help. About 44,335 male patients who had been diagnosed with androgen deficiency took part in the study. But the effectiveness of testosterone has been controversial.

And the findings of five studies released Tuesday aren't likely to clear up the confusion.

Lastly, the trial for cardiovascular health revealed more coronary artery plaque buildup in testosterone-treated men compared with the placebo group. The results are based on 788 men with below normal levels of testosterone studied at 12 sites across the country over a year.

Thomas Gill, a professor of medicine at the Humana Foundation and a lead author of the research, said the latest studies demonstrate that if a man with low testosterone is prescribed the hormone for diminished sexual function, he may have some additional benefits on hemoglobin levels and bone density. The treatment also increased hemoglobin concentrations, corrected the anemia of men who had no other identifiable cause of anemia and corrected the anemia of men who had an identifiable cause, such as iron deficiency.

■ Testosterone had no effect on memory or mental function, based on tests given before, halfway, and at the end of treatment to almost 500 men with age-related memory decline. His comments appear in an editorial in JAMA. Measurement of testosterone might be considered in men age 65 and older who have unexplained anemia and symptoms suggestive of low testosterone levels. He also called for strengthened warnings on the drug's packaging to note the cardiovascular risk.

In another JAMA editorial, Eric Orwoll, a professor of medicine at Oregon Health & Science University, noted that the TTrials did not address the critical issues of whether there are important long-term adverse effects. He added that patients and doctors should be more positive about the use of testosterone replacement therapy following the results of the study. Half the men in each group used the real thing and half used fake gel. Testosterone therapy now carries a boxed warning of potential heart risks, mandated by the FDA.

The scientists in the TTrials studies found that after one year of testosterone therapy, bone density and strength of the men improved and anemia was reduced. Today's publications of the Bone, Anemia, Cognition and Cardiovascular Trials conclude the primary results of the study. Over a year, investigators measured the effects of testosterone on four areas: anemia, bone density and strength, cardiovascular health, and cognitive function.

"The paper reporting the results of the first three trials published a year ago was the first to show there were advantages to giving testosterone treatment to older men with low testosterone levels, and the bone and anemia trial results further support a benefit". Similar to women, men experience a normal decline in sex hormone levels beginning in their 30s.

Still, about 2,000 men sued AbbVie and other testosterone makers. The total number of major cardiovascular negative health outcomes in testosterone-treated men was comparable with those observed in the control group.

The first set of TTrial studies was reported previous year in the New England Journal of Medicine. In addition to low testosterone, the presence of complaints such as low sexual function, difficulty in walking or low vitality was required for eligibility to participate in the trials. These changes may be of clinical significance, as suggested by the magnitude of the changes, the correction of anemia in the majority of men, and the association of the increases with improvements in global impression of change in overall health and energy.

The researchers say more studies are needed to check if this means that men who take testosterone are then at increased risk of heart problems.

A separate study published Tuesday in JAMA Internal Medicine found that men using prescription testosterone gel, patches, or injections had fewer heart attacks and strokes during about three years of follow-up than non-users.

The results are from the final four studies in a seven-part project mostly funded by the National Institute on Aging, involving almost 800 USA men aged 65 and older with low testosterone levels. Such studies are considered less reliable than randomized placebo-controlled studies, which can be scientifically created to determine whether an apparent effect is actually causal.

  • Joanne Flowers