testosterone gel

Testosterone gel is no fountain of youth, study finds

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Dave Bostick and wife Carol share a laugh in the kitchen of their home in Pittsburgh, Tuesday, Feb. 16, 2016. Bostick, 71, a retired vocational rehab counselor, said his low mood and energy level improved "a little bit" during a testosterone treatment study but suddenly worsened afterward. He said he has resumed using testosterone at his doctor's recommendation and isn't overly concerned about the potential risks. Something's going to get me sooner or later," Bostick said. (AP Photo/Gene J. Puskar)

Dave Bostick and wife Carol share a laugh in the kitchen of their home in Pittsburgh, Tuesday, Feb. 16, 2016. Bostick, 71, a retired vocational rehab counselor, said his low mood and energy level improved “a little bit” during a testosterone treatment study but suddenly worsened afterward. He said he has resumed using testosterone at his doctor’s recommendation and isn’t overly concerned about the potential risks. Something’s going to get me sooner or later,” Bostick said.

A landmark study suggests that testosterone treatment is no fountain of youth, finding mostly modest improvement in the sex lives, walking strength and mood of a select group of older men.

The long-awaited results from a rigorous, government-funded study are the first solid evidence of whether these hugely popular supplements can help treat low sex drive, lack of energy and other symptoms sometimes blamed on aging.

The researchers emphasized that the findings pertain only to use of testosterone gel by men 65 and older with low hormone levels and related symptoms; whether similar benefits would occur in younger men or with testosterone pills, patches or shots is unknown.

Also, the research was not extensive enough to determine whether long-term use raises the risk of heart attacks and prostate cancer, as some studies have suggested.

Lead author Dr. Peter Snyder, a University of Pennsylvania hormone specialist, said it would be premature to recommend the treatment even for men like those studied.

“Making a recommendation depends on knowing all the benefits versus risks,” he said. “We still don’t know everything we want to know.”

The study involved almost 800 men 65 and older at 12 centers nationwide. All had low blood levels of testosterone, the main male sex hormone. They were randomly assigned to use testosterone gel or fake gel without hormones, rubbed daily on the skin for a year. They had to fill out questionnaires and take a six-minute walking test.

The study design is considered the most rigorous, gold-standard type of research.

Improvement in sex lives was modest among the testosterone group, and the benefits in erectile function were less that what has been seen with Viagra and similar drugs. The men on testosterone had slightly greater improvement in mood and walking strength than the other men, but there was no difference in energy boost between the two groups.

The research is among seven testosterone studies the National Institute on Aging launched in 2009 to examine the risks and benefits of testosterone supplements widely marketed on television to men with “low T.”

Testosterone levels typically decline with age. Supplements are approved only for treating testosterone deficiency caused by certain medical conditions, such as problems with the testes, but they have become a multibillion-dollar industry, feeding on aging men’s desire to remain youthful. The men in the study did not have any of those specified conditions.

The new research combines results from three of the government-funded studies. Results are expected later from the four other studies, which tested the hormone’s effects on mental function, bone density, heart function and anemia.

The current results are in Thursday’s New England Journal of Medicine.

The findings “bring some real rigor” to questions surrounding testosterone use and suggest that the treatment is “not a panacea” for age-related ills, said Dr. Eric Orwoll, a physician-researcher at Oregon Health and Science University in Portland.

On average, the testosterone increased men’s hormone levels to what would be normal for someone 19 to 40 years old.

About 20 percent of testosterone men reported much improved sexual desire, and 30 percent reported a slight improvement, but almost half reported no change. Less than one-third of the fake-gel men reported any improvement in sexual desire.

On the walking test, testosterone and placebo men showed similar improvements when the comparison was only among men who started out with low scores. When the comparison was expanded to include other study men, about 21 percent of testosterone men achieved the walking goal versus about 13 percent of those on a placebo.

Snyder said those findings suggest but don’t prove that the hormone builds muscles and increases strength and energy.

The men in the study didn’t learn until it was over whether they had been given testosterone or the fake gel.

Dave Bostick, who participated at the University of Pittsburgh, said that as soon as he stopped using the gel he correctly guessed he had gotten the real thing. Bostick, 71, a retired vocational rehab counselor, said his low mood and energy level improved “a little bit” during the study but suddenly worsened afterward.

He said he has resumed using testosterone at his doctor’s recommendation and isn’t overly concerned about the potential risks.

“Something’s going to get me sooner or later,” Bostick said.

A small number of men had heart attacks or were diagnosed with prostate cancer during or after the study, but the rates were similar between the two groups. Dr. Richard Hodes, director of the National Institute on Aging, said the agency is awaiting results from the additional testosterone studies to determine whether to pursue research on potential long-term risks.

ABBVie Pharmaceuticals provided its AndroGel for the study and helped pay for the research but was otherwise not involved.

Company spokeswoman Libby Holman called the research “an important contribution” to understanding the role of testosterone therapy.

Injectable Testosterone Tied To Higher MI, Stroke Risk Than Gels

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Injectable testosterone is associated with a higher short-term risk of cardiovascular events compared with testosterone gel or patch formulations, according to a new epidemiologic study of three large, diverse databases, which is the first research to compare cardiovascular events associated with different testosterone formulations.

The study is published online May 11 in JAMA Internal Medicine.

“There’s a large spike of serum testosterone that happens after an injection, so the injections may carry a slightly higher cardiovascular risk,” lead author Dr J Bradley Layton, from the University of North Carolina at Chapel Hill, told Medscape Medical News.

“The US Food and Drug Administration has just ruled that testosterone is really indicated and approved only for men with very specific endocrine disorders and not just general age-related decreases in testosterone,” he stressed.

Thus, clinicians considering starting a patient on testosterone should carefully consider the medical reasons for this therapy, he advised.
“With continuing concern about the safety and effectiveness of testosterone treatment in men with primary and age-related hypogonadism and the trend of treatment in men with normal testosterone levels or without recent baseline testing, it is important to understand the potential hazards of testosterone treatment,” he and his colleagues conclude.

And in an accompanying editorial, Dr Margaret E Wierman, from the Denver Veterans Affairs Medical Center, in Colorado, writes that the study findings support the Endocrine Society guidelines that recommend testosterone therapy purely for men who have hypogonadism as opposed to only low serum testosterone levels or related symptoms.

“The absolute risk [of cardiovascular events] between testosterone-therapy groups was small in this epidemiologic analysis, but the risk does raise concern, considering the marked increase in testosterone prescriptions both in the United States and internationally,” she adds.

More Than 500,000 Men in Three Cohorts

There have been mixed reports regarding adverse cardiovascular events with use of testosterone, Dr Layton and colleagues write.

Although it is known that testosterone injections cause spikes in serum testosterone levels, whereas transdermal patches and gels cause more subtle but sustained increases, until now, no studies have compared the cardiovascular safety of the different testosterone formats.
The researchers performed a retrospective cohort study in 544,115 men who had just been prescribed testosterone therapy after not having had any in the past 6 months.

The data came from three cohorts:

  • 515,132 men in the United States with employer insurance (through Truven MarketScan) who made insurance claims for testosterone from 2000 through 2012.
  • 22,376 men in the United States with Medicare insurance who made insurance claims for testosterone from 2007 through 2010.
  • 6607 men in Great Britain who were seen by general practitioners and had healthcare claims for testosterone from 2000 until 2013,

The average age of men in the Medicare cohort was about 73, whereas the average age in the other two cohorts was about 54.

More men in the employer-insurance cohort received testosterone as a gel (56.5%), and the rest received an injection (36.7%) or, less often, a patch (6.8%). In the Medicare cohort, more men received an injection (51.2%), and the rest received a gel (42.9%), and again, less often, a patch (5.9%).

In the UK cohort, about the same percentage of men received a gel (42.4%) or an injection (39.6%), and a fair number received patches (18.1%).

Compared with men using testosterone gels, men receiving testosterone injections were more likely to have a cardiovascular event (myocardial infarction, stroke, or unstable angina), be hospitalized, or die within a year of starting treatment. Rates of venous thromboembolism did not differ between the formulations.

Risk of Outcome Within 1 Year, Testosterone Injection vs Gel

Outcome HR (95% CI)*
MI, unstable angina, or stroke 1.26 (1.18–1.35)
Hospitalization 1.16 (1.13–1.19)
Death 1.34 (1.15–1.56)
Venous thromboembolism 0.92 (0.76–1.11)
*Adjusted for multiple confounders

These risks were similar among users of testosterone gels and patches.

Risk of Outcome Within 1 Year, Testosterone Patch vs Gel

Outcome HR (95% CI)*
MI, unstable angina, or stroke 1.10 (0.94–1.29)
Hospitalization 1.04 (1.00–1.08)
Death 1.02 (0.77–1.33)
Venous thromboembolism 1.08 (0.79–1.47)
*Adjusted for multiple confounders

The 1-year rates of cardiovascular events and mortality were higher in the older Medicare cohort, and hospitalization rates were higher in the US cohorts.

Many Start Testosterone Without Testing

Many patients were started on testosterone without any record of serum testosterone test results or relevant diagnoses, but the researchers did not have complete data for this.

However, the findings are consistent with the “recent alarming US Food and Drug Administration report that more than 25% of testosterone prescriptions in the United States are written without determination of a [testosterone] level and that more than 30% of patients receiving testosterone therapy do not have follow-up laboratory testing,” Dr Wierman writes.

During the course of the study, the use of gels increased and use of the other formats decreased, which is “somewhat reassuring,” she adds.

The lack of evidence of a signal for venous thromboembolism was another important finding, and study strengths include the large number of men and patient and prescriber diversity.

The findings emphasize the need to prescribe testosterone only when warranted and to be aware of potential risks with certain formats and with values exceeding physiologic ones.

The study “can reassure physicians who rationally provide treatment for men with true hypogonadism with approaches that result in physiologic levels of testosterone, which is a safe and effective therapy,” according to Dr Wierman.

It also “[hints] that injectable Depo-Testosterone [testosterone cypionate, Pfizer] or other formulations that consistently result in levels outside the physiologic range should be restricted or at least more carefully monitored for cardiovascular risk.”