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“The findings are a boost for proponents of testosterone therapy but aren’t likely to settle the long-standing debate over testosterone safety any time soon.”
Wall Street Journal, July 5-6, 2014

Study Balances Risk of Testosterone Therapy

No Heart Attack Risk—May be Protective

Exercise Helps, Obesity Hinders

It will be my fifth article on testosterone replacement therapy--and the first that might be said to encourage it. (It's fairly long and detailed. Stick with me. You'll be glad you did.)

In 2007, I wrote about a study which found that age-related testosterone decline can be substantially slowed through “management of health and lifestyle factors.” (Article #193)

In 2010, a study was halted prematurely when subjects given testosterone began having heart-related problems; one man died. (#273)

In 2013, a study found that the remedy for Low T may be more estrogen. (#368)

Most recently, a controversial study found that testosterone therapy raised the risk of death, heart attack, and stroke by 30%. (#375)

AND NOW, positive news: a study of 24,000 Medicare patients (over age 65) found that testosterone therapy did not increase the risk of heart attack. Moreover, it lowered the risk by 30% in men judged most vulnerable to heart attack.

Let’s look at the details and then have another look at the status of TRT. (We'll also check out a very interesting study of 40 clinics specializing in Low T therapy--and what you can do to help achieve maximum benefit.)

(Published online in the Annals of Pharmacotherapy, she study compared 6355 Medicare beneficiaries injected with testosterone with 19,065 who were not treated. The patients given testosterone were experiencing hypogonadism (low testosterone production), sexual dysfunction, fatigue, or osteoporosis. The patients were followed for up to eight years. (The study was also reported July 3, 2014, in Medscape Medical News.) 

The researchers called attention to both the good and the bad ramifications of TRT. First author Jacques Baillargeon, PhD, University of Texas Medical Branch, Galveston, listed the following mechanisms that could explain the protective effect of TRT: decreased fat mass, increased lean body mass, improved insulin sensitivity, lipid profile, and reduced inflammation. “There are also plausible pathways whereby it could increase cardiovascular risk, so there are arguments to be made both ways,” Baillargeon told Medscape Medical News.

Manner of administration is also a consideration.

Importantly, testosterone was administered by intramuscular injection. Gel, patch, and oral formulations are now more common because the risk with injections is thought to be higher. “Endocrinologists have worried that the injections would create the greater risk of cardiovascular disease because testosterone levels after injection may be super normal [too high or too low],” co-author Randall J. Urban, MD, also of the University of Texas Medical Branch, told Medscape Medical News. “A negative finding in the presumed highest-risk delivery system is therefore reassuring,” he added.

“Our study brings some balance to the discussion, and I think it has far-reaching clinical and public-health implications,” Dr. Baillargeon told The Wall Street Journal. (July 5-6, 2014)

More Responsible Prescribing

“This study joins a legion of epidemiological studies showing conflicting results on the effects of testosterone therapy and cardiovascular risk,” Bradley D. Anawait, MD, chief of medicine at the University of Washington Medical Center in Seattle, told Medscape Medical News. “This study examined a much larger cohort than most of the other published studies and had a longer follow-up period,” he added.

A positive development likely to emerge from deliberation over testosterone safety is a heightened awareness of the need for more responsible prescribing of testosterone, Dr. Anawait observed.

”The concern of a potential risk with testosterone therapy is at least useful for practitioners who are trying to responsibly restrict testosterone prescriptions to patients who truly are hypogonadal and not simply seeking a fountain of youth,” Anawait concluded.

*  *  *

A study of data from 40 clinics specializing in Low T therapy around the country may be indicative of what can result from more responsible prescribing; the results may also be a little too good to be typical. The study was presented at the American Association of Clinical Endocrinologists (AACE) 23rd Annual Scientific and Clinical Congress by Robert Tan, MD, director of the Opal Medical Clinic, Houston, research director of the Low T Institute, and clinical professor of family and community medicine at the University of Texas. Dr. Tan is an active practitioner of testosterone therapy in his own clinic, which is not related to Low T Centers. (Study details were reported in Medscape Medical News, May 18, 2014.)

Among 19,968 hypogonadal men who received testosterone therapy between 2009 and 2014 at Low T Centers nationwide (www.lowtcenter.com), the risk of heart attack was 7-fold lower and the risk 9 times lower than patients in the general population. Additionally, there was no evidence of worsening in patients who had suffered a heart attack or stroke before receiving testosterone.

“There has been a lot of hype and concern….I want to try to explain the other side of the story,” Dr. Tan said in introducing his presentation.

The Tan study was part of an internal quality-management program at the Low T Centers, which follow strict protocols requiring a definitive diagnosis of hypogonadism (total T < 350 and free T < 10) for starting testosterone therapy. Patients are also closely monitored while on treatment, with regular 1- or 2-week physical assessments and laboratory work.

Importantly, this was a “look back” or after the fact study, while the gold standard is a randomized controlled trial [RCT], which intervenes and then looks forward to see what happens.

Dr. Tan reviewed the charts of Low T Center patients given testosterone. Of 39,937 patients seen during the five year period, approximately 50% met the criteria for treatment. Of the patients given testosterone, four had nonfatal heart attacks, and three had probable fatal heart attacks; a rate of 30 new heart attacks per 100,000 patients. Of patients who had a heart attack prior to therapy, none had additional heart problems after receiving testosterone.

There were two strokes among treated patients, or a rate of 10 new strokes per 100,000. Of 12 patients who had a stroke before therapy, none had adverse events after testosterone.

Because patients who did not qualify for testosterone therapy were not followed up, Dr. Tan and colleagues compared their figures with those from other published data from the general population.

The rate for heart attack at Kaiser Permanente Northern California was 208 per 100,000, and the stroke rate found in the Northern Manhattan Registry was 93 per 100,000.

“Our study showed that carefully monitored testosterone therapy may actually protect against [heart attack] and stroke. It’s retrospective, but I think it’s as good as we can come up with. At least from our experience, there was no evidence of increased heart attacks or strokes from people treated with testosterone,” Dr. Tan stated.

Why were Dr. Tan’s results so much better that other studies? He suggests that it is because the Low T Center population was subject to more stringent screening before treatment and received regular follow-up, and had longer exposure to testosterone therapy.

Session moderator and AACE president-elect George Gruberger, MD, was more circumspect in his assessment. “I was glad to see this, and it is important, but you have to take it at face value when you look at retrospective chart review….Before you start making claims, you need [a] truly high-level, classy randomized trial [RCT],” he told reporters. “RCTs cost hundreds of millions of dollars,” he hastened to add. “The economics, the math is just incredibly complex…That’s the sad reality. I really don’t know if there’s a short cut….So clinicians just have to fly by the seat of their pants…That’s the dilemma.”

That is the dilemma many face. If you and your doctor decide that you are an appropriate candidate for testosterone replacement therapy, there are things you can do to help achieve maximum benefit.

Exercise Helps, Obesity Hinders

Men who exercise regularly benefit more from testosterone replacement than men who remain sedentary, according to a study lead by Min Gu Park, MD, Department of Urology at Inje University in Seoul, South Korea.

The Park team found that testosterone levels were significantly higher in the group doing aerobic exercise and strength training three times a week for 12 weeks. Resolution of low T syndrome was also better in the exercise group. Notably, the benefits of exercise remained after therapy was stopped. (The men all had similar testosterone levels at the beginning of the study.)

A separate study looked at predictors of poor response to testosterone therapy; the investigators found that nonobese men are much more likely to achieve normal testosterone levels than obese men.

“Weight loss may be as important as prescribing testosterone in the management of low T, said lead researcher Ashley Winter, MD, a urology resident at Weill Cornell Medical College in New York City.

Winter and her team observed that 16% to 22% of men with low testosterone do not achieve normal testosterone levels with treatment—and set out to determine why.

They followed 58 patients with low T syndrome who were treated with testosterone for 18 to 24 months. The men, similar in age and testosterone level, were categorized as obese (>30 BMI) or nonobese (<30 BMI). The researchers found that the nonobese men were more likely than the obese men to achieve a normal testosterone level by a margin of 81% to 54%.

Both studies were presented at the American Urological Association 2014 Annual Scientific Meeting—and reported in Medscape Medical News, May 27, 2014.

“Clearly the answer is that patients have to eat more nutritious food and less garbage, exercise more, and take better care of themselves,” meeting moderator Tobias Kobler, MD, MPH, associate professor of urology at Southern Illinois University School of Medicine in Springfield, told Medscape Medical News. “I think that a lot of the controversy around testosterone is about guys who use it for the wrong reason. They’re not trying to restore a normal physiologic state, they’re trying to achieve a super-physiologic state. There, we have to be cautious, to make sure that it’s in the right hands.”

*  *  *

That about sums it up. First, help yourself. If you can’t manage alone, help your doctor help you. Don’t expect testosterone therapy to make you a superman; you’ll have more success doing that on your own.

Below is one of my first physique photos; it appeared in Iron Man magazine. It was taken by my next door neighbor in 1974 when I was 36 years old. I had been training regularly for over 20 years, but had only recently turned my attention to bodybuilding. The main change was that I was paying more attention to my diet and riding my bike once a week. I don’t know my testosterone level, but it was clearly adequate. The second photo shows me in the gym 34 years later.


                                                                                                                                                          Clarence at 36--and 70.  Photos by Bill Vollendorf and Laszlo Bencze

For more photos from 15 to 76 see our training pictorial http://www.cbass.com/PICTORAL.HTM  

Recent testing at the Cooper Clinic in Dallas showed that my testosterone is still “very healthy.” http://www.cbass.com/ClarenceBassCooperClinic14.htm

Except for a brief period documented in my book Ripped, all of this has been accomplished by lifestyle alone.

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