Posts Tagged ‘testosterone and heart disease’

What You Need To Know About Low T (Testosterone) and Heart Disease

March 27, 2014

I have received dozens of calls from men who are concerned about the recent study that reports that testosterone replacement therapy increases the risk of heart attacks and strokes. This blog is intended to clarify some of the misinformation that is attracting so much media attention. The Androgen Study Group, a large group of physicians and researchers of which I am a member, is calling for the retraction of the paper that appeared in the Journal of American Medical Association linking testosterone and cardiovascular risks — data that its authors of the paper in the journal are standing firmly behind.

In a letter to Howard Bauchner, MD, editor-in-chief of the Journal of the American Medical Association, members of the group — formed in response to the paper and comprised of more than 125 doctors — said the study’s credibility was compromised by at least two corrections and should be pulled from the journal.
A close friend and colleague, Dr. Abraham Morgentalker pointed out the there’s no misconduct, no one faked any data, it’s just sloppy. The group called it “gross data mismanagement.”

The paper, published in JAMA in November by Michael Ho, MD, PhD, of the Eastern Colorado VA, and colleagues, found that testosterone therapy was associated with a greater risk of death, heart attack, and stroke in male veterans who’d had coronary angiography. (If the men were having coronary angiography, it stands to reason that they already had some heart disease or they wouldn’t have been subjected to this invasive procedure)

But two corrections have since been published. The first, in the Jan. 15 issue, was a clarification that the results were based on “estimates” and not raw data.

The second, which Morgentaler and colleagues focus on in their letter to the editor of the journal, involved reclassivication of patient who were excluded from the study. More than 1,000 excluded patients were assigned to different categories of exclusion, including 100 who were women!

The authors included almost 10% women in an all-male study, so why should we believe any of the other data? The Androgen Study Group points out that the data were so off that it’s hard to believe the data for the entire study are accurate.

However, Ho and colleagues said they “stand firmly by the results of our study,” noting that the overall number of excluded patients remains the same, as does the total number of included patients, and the main results of the study were not changed.

The study group said that these claims run contrary to 40 years’ worth of research on testosterone, which suggests that the hormone has some beneficial effects in certain heart patients.

But the testosterone therapy field has garnered much media attention for its financial relationships with industry. Several articles in the New York Times, including one on the marketing of “Low T”, another on the selling of testosterone gels, and an editorial, have questioned the potential overselling of the therapy.

It is true that several members of the Androgen Study Group, myself included, have relationships with testosterone drug makers, such as AbbVie, Watson, and Endo Pharmaceuticals.

It is my opinion that men who are symptomatic for low testosterone and have complaints such as lethargy, decreased libido, loss of muscle mass, and decrease in erections or potency AND who have a documented decrease in the blood level of testosterone, are good candidates for hormone replacement therapy. These men who are going to receive testosterone should have a normal digital rectal exam and a normal PSA test if they are less than 75 years of age.

Bottom Line: Low testosterone has effects that impact a man’s quality of life. If a man has symptoms of low T and a documented decrease in the blood testosterone level, he should speak to his physician about testosterone replacement therapy.

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Testosterone And Heart Disease – Facts and Caveats

November 6, 2013

Like most urologists, endocrinologists, and cardiologists, I have received numerous calls from men who have symptoms of low testosterone, documented decrease in their blood testosterone level, and who are receiving testosterone replacement therapy about a study that appeared in a reputable medical journal that treatment with testosterone increases the risk of heart disease. (JAMA. 2013;310(17):1829-1836. doi:10.1001/jama.2013.280386).

Let’s look at some facts. The human body is always trying to achieve homeostasis which is defined as “The ability or tendency of an organism or cell to maintain internal equilibrium by adjusting its physiological processes.” What does this mean? It means that the body is always trying to stay normal without deviations from normal. For example, if a man drinks too much water, the kidneys will increase the excretion of water. If a man is dehydrated, the kidneys will try and conserve water to prevent the problems associated with dehydration. If a man has diabetes, the doctor will recommend a treatment to lower the blood sugar. If a man has high blood pressure, the doctor will recommend dietary changes, exercise, and perhaps medication to lower the blood pressure. If a man has anemia or a low blood count because of iron deficiency, the doctor will prescribe iron supplements. If a man has a deficiency in vitamin D, then the doctor will recommend increase the consumption of this necessary vitamin. These actions are what doctors do every day; they attempt to achieve a normal equilibrium in the body as this is the best way to restore and maintain health.

This same reasoning applies to men who are deficient in testosterone. Testosterone is a necessary hormone produced in the testicles that is responsible for a man’s sex drive, muscle mass, energy level, bone strength, and even a man’s mood which may cause depression if the hormone is low and not returned to normal.

There are more than 13 million men in the United States who suffer from testosterone deficiency. For men who receive treatment, they usually report significant improvement in their symptoms. There are many conflicting reports about testosterone and heart disease. There are even studies that support that low testosterone increases the risk of heart disease and that treating the deficiency with hormone replacement therapy may be protective of heart disease.

I would like to list several comments about the study that was reported in the recent Journal of the American Medical Association (JAMA).

Of nearly 7,500 guys who did not get extra T, about 1 in 5 had bad cardiovascular outcomes, including stroke, heart attack or death. In the more than 1,200 men who got testosterone, nearly 1 in 4 had those terrible problems, an increased risk of nearly 30 percent. A truly scientific study has similar number of study patients in each group, not 7500 in the control group and 1200 in the experimental group.
The researchers concluded that taking testosterone came with an increased risk of an adverse outcome. If a statistician would add up the actual reported events in the paper for each group and divide by the numbers of men in each group. What you will find is that the absolute risk of events (death, heart attack, or a stroke) was 10% in men treated with T and 21% in men not treated. That’s right- the risk was REDUCED BY HALF in men treated with T. So a closer scrutiny needs to be done before conclusions can be made and distributed to the media.
This is obviously the opposite of what the authors reported. They come up with absolute risk rates that are not explained by any numbers in their paper. They used a complex statistical analysis to get to their conclusions without showing the numbers it was based on.

That’s not the whole story, though. Dr. Anne Cappola of the Perelman School of Medicine at the University of Pennsylvania wrote in an accompanying editorial: “The most important question is the generalizing the results of this study to the broader population of men taking testosterone ….” The take home message is not possible to generalize from this study to the entire population of men some of whom may have a low testosterone level.
That’s a very big caveat: By definition, all the men in the study were older than 60 and all had heart problems. It’s still not clear whether those same risks apply to younger, healthier guys.
“These were sick, older veterans,” Dr. Michael Ho, a cardiologist with the VA Eastern Colorado Health Care System who helped direct the study, said in an interview. Many were obese, had diabetes, and other ailments, he said. Obese men with diabetes and other co-morbid conditions are certainly at risk for heart disease, stroke, and even death.

Bottom Line: So what is a man who has low testosterone to do? I would suggest that they have a discussion with their doctor. If they have symptoms of low testosterone, and a documented level of low testosterone blood test, then the doctor and the patient have to weight the risks of testosterone replacement therapy versus the benefits. Certainly if the benefits outweigh the risks and the risks are composed of an older man with heart disease, diabetes, and other illnesses, then raising the testosterone level may not be in his best interest.