Our team of researchers from LA BioMed and 12 other medical centers in the US, in partnership with the National Institute on Aging, conducted a coordinated group of seven trials known as The Testosterone Trials (TTrials).
"The increase in coronary artery noncalcified and total plaque volumes in men treated with testosterone is concerning because any limitation of the vascular lumen could be considered deleterious", they wrote in the February 21 issue of the Journal of the American Medical Association.
Clarifying testosterone's effects on heart problems, fractures and age-related disability will require larger, longer studies, said Dr. Evan Hadley of the National Institute on Aging.
But there are conflicting studies when it comes to testosterone improving older men's health.
The first set of TTrial studies was reported past year in the New England Journal of Medicine.
Many men age 65 and up who have low levels of testosterone say their sense of well-being, not to mention their libido, isn't what it used to be.
For the bone density and strength study, researchers used quantitative computed tomography to assess spine and hip bone mineral density at baseline and a year later.
Bone Trial - Improvement in bone density and strength.
That's because there already are other well-established and more effective treatments that focus on more specific sources of bone disease and anemia than low testosterone, Gill said.
A second study found that the gel was associated with an increase in the percentage of men who recovered from mild anemia, both when the source of the condition was known (an iron deficiency) and unknown.
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The participants were then randomly divided into two groups: one group took a daily dose of testosterone in the form of a gel for a year, while the other group took placebo for the same period of time.
As men advance in age, their levels of testosterone naturally start to decrease.
Among the 8,808 men ever prescribed the hormone given by injection, orally or topically, cardiovascular outcomes over a median follow-up of 3.2 years, the composite adjusted hazard ratio for acute MI, coronary revascularization, unstable angina, stroke, transient ischemic attack (TIA), and sudden cardiac death was 0.67 with any testosterone prescription (95% CI 0.62-0.73).
The red flag on cardiovascular risk was raised in the TTrials' Cardiovascular Trial, where researchers found an increase in plaque buildup, a known risk factor for heart disease. The fifth study is observational and examines the links between testosterone treatment and overall cardiovascular health.
For some experts, the results of the $50 million trial were a letdown. The total number of major cardiovascular negative health outcomes in testosterone-treated men was comparable with those observed in the control group. Four present findings from a set of clinical trials known as the Testosterone Trials, created to evaluate the effects of testosterone therapy in men age 65 or older.
Final decisions about testosterone treatment for older men will depend on "balancing the results" from the TTrials "with the results from a much larger and longer-term trial created to assess cardiovascular and prostate risk", says endocrinologist Peter Snyder of the University of Pennsylvania, who headed the studies.
AbbVie provided funding, AndroGel, and placebo gel.
PATTI NEIGHMOND, BYLINE: The studies, called the TTrials, were conducted at 12 medical centers across the country.
NEIGHMOND: Longer-term research is needed, she says, to make sure stronger bones mean fewer fractures as men age. "It's unlikely testosterone would be prescribed either for bone or for anemia". The men in the study who were using the testosterone gel experienced a significantly greater buildup of plaque in their arteries compared to the men who were taking the placebo.
"I would say, ‚We have uncertainty about the health effects of testosterone and your risk of heart attacks". They weigh the available evidence and individualize their treatment decisions and have that conversation with their patients about the uncertainty, about the risks and benefits.