New Research Proves Testosterone Replacement Therapy is Safe for the Heart

Posted by Dr. Michael White, Updated on October 31st, 2022
Reading Time: 9 minutes

Testosterone Replacement Therapy DOES NOT Increase Heart Attack Risk

Recently, the mainstream media began sounding dire warnings about Testosterone Replacement Therapy (TRT).

A recent study was published by the non-profit journal, PLOS One, claiming that in the initial three months of TRT, men were more likely to experience a heart attack if they have previously experienced the cardiovascular disease.

However, when looked at unemotionally and in detail, the study appears to have overlooked several key factors.

This is just one of a barrage of studies that have employed questionable methodologies but used shock value and fear tactics that resulted in hysterical headlines across television, print, and the web.

If that weren't enough, a similar study was released last year in the Journal of the American Medical Association (JAMA), which also concluded that Testosterone injections and creams increase the risk of a heart attack.

That study also had numerous issues that led to faulty conclusions.

Let's take a look at them.

The Important Relationship of Estrogen and Red Blood Cell Counts to Testosterone

Both studies mentioned above contained a glaring error: neither study measured Testosterone levels before and after Testosterone treatment.

Also, there was yet another massive problem with the methodologies of both of these studies: they failed to perform necessary screening tests before treatment started that would have likely disqualified some high-risk patients from receiving the therapy, including Estrogen Testing and the Complete Blood Count.

This lack of screening was inexcusable.

These two tests are crucial because elevated estrogen levels and red blood cell counts have been previously associated with an increased risk of complication when administering TRT.

The three variables of Endogenous Testosterone Production, Estrogen Production, and Red Blood Cell Count are all tests that are required to determine both whether a patient qualifies for therapy or needs to cease treatment.

Therefore, since these crucial tests were conveniently forgotten, many mistakenly believe patients should be informed that Testosterone Replacement Therapy increases the risk of heart disease and heart attack as a direct result of treatment.

This is one time when doctors should be aware of TRT's realities.

Our physicians are undoubtedly dedicated to their patient's well-being.

However, they can't be on top of every new treatment.

This is why it's crucial to increase physicians’ awareness regarding particular issues that can raise the potential risks of Testosterone Replacement.

High Red Blood Cell Counts Easy to Treat

Medical professionals must monitor all three of these variables before and during TRT to minimize the health risk to the patient.

Even if these tests indicate that problems are arising from TRT, these problems have solutions.

For example, suppose the patient has an elevated RBC count after several months of therapy. In that case, the physician can adjust the Testosterone Dosage or only make sure the patient donates blood to decrease his RBC count, substantially reducing the risks of heart attack, stroke, and clotting.

Medications Available to Control Estrogen Safely

High Estrogen also increases stroke and heart attack risk, but it can be monitored and treated with an elevated RBC count.

If tests show that the patient is suffering from high Estrogen levels, powerful and effective medications can control Estrogen Levels, reducing them to normal.

The sad fact is this: these studies DID NOT perform due diligence to protect their patients from the well-documented and easily preventable risks associated with TRT, and they got wrong, insufficient data as a result.

Viagra Used by Control Patients Significantly Distorts Results

Still another problem with this study is this: several men were taking PDE5 inhibitors, and this group was compared to other patients WHO WERE NOT taking PDE5 medication.

It seems evident that the study's authors would have disclosed this in the name of scientific objectivity.

But this critical fact was ignored and not mentioned at all...not one word.

Researchers discovered that patients taking these medications (Viagra and Cialis), were less likely to experience heart complications during treatment.

The authors included PDE5 inhibitors in an attempt to make sure all patients were able to perform sexually.

They used PDE5 drugs to control for the improved libido associated with increased Testosterone.

They ignored that PDE5 inhibitors not only affect sexual function in males but can also affect cardiovascular health in several beneficial ways.

Two forms of PDE5 Inhibitors have been FDA-approved for the treatment of hypertension because these medications can reduce blood pressure by relaxing blood vessels.

The Journal of Cardiovascular Pharmacology and Therapeutics recently released a study that provides compelling evidence that PDE5 Inhibitors are useful as heart drugs for people suffering from coronary artery disease.

The study also points out that these drugs can improve heart failure patients' health outcomes.

The potential cardiovascular benefits of PDE5 Inhibitors make these drugs a safe method of controlling potential heart risks of TRT since men taking PDE5 drugs will have healthier hearts on average than men who don't take them.

By ignoring this fundamental fact, the study makes TRT appear more dangerous than it is.

Latest Research Indicates Testosterone Replacement Therapy is Safe

Although this PLOS One study is receiving tons of media coverage, it contradicts twenty years of research showing that testosterone patches, injections, and creams can improve heart health by increasing muscle mass and reducing body fat while balancing blood sugar and cholesterol.

The combined outcomes of earlier research like the PLOS One study have left doctors without concrete tips on treating males for low testosterone (“Low-T”), with the FDA advising against over-prescription due to a high danger of coronary heart assault and stroke.

However, the Times are Changing

The Journal of the American Heart Association recently released a research survey that further reduces the credibility of the PLOS One article.

In this review, over one hundred studies were analyzed, searching for evidence of how TRT impacts patients' cardiovascular health.

Their conclusion?

Testosterone deficiency is undeniably linked to severe mortality risks, including increased incidence of diabetes and obesity, an elevated risk of heart attack, stroke, and other dangerous cardiovascular conditions such as atherosclerosis.

Researchers also discovered that the more severe the testosterone deficiency, the more dangerous the symptoms manifested themselves.

Testosterone is a hormone that acts as a "fountain of youth" in some ways for men.

The chemical peaks in male bodies during their teen years and declines as men grow older.

Symptoms of this loss can include reduced sexual desire, sleeplessness, increased body fat, and hair loss.

This hormone can be replaced through injections, patches, or a topical gel.

Despite this, few studies have been conducted on the safety of supplementing the male sex hormone.

Low testosterone is becoming a more significant concern in recent years as people become more aware of the condition.

Some advertisements for prescription drugs encourage men feeling lethargic or losing interest in sex to ask their doctors about the hormone.

However, this does not always drive changes in men as they age.

"Sometimes it is testosterone, sometimes it is the thyroid, and sometimes it's something unrelated to hormones," according to Dr. Spyros Mezitis, a physician experienced in treating Low-T.

Further studies will examine testosterone's role in mitigating the risks of heart attacks and strokes.

Possible side effects in patients will also be reviewed to determine if the risks of TRT are manageable.

Earlier studies have suggested that such treatments could be tied to sleep apnea (rough breathing), the increased growth rate of prostate cancer, and blood clots.

A Veterans Administration Study Adds More Fuel to the Fire

A Veterans Administration study of more than 83,000 patients determined that men with low testosterone levels returned to normal had a lower risk of heart attack, stroke, or death than men who did not receive testosterone.

The study also found that men treated but didn't regain healthy levels did not experience the same benefits as those whose levels reached an average range.

The study was published online in the European Heart Journal on Aug. 6, 2015.

The conclusions might lead the way to a sea-change concerning testosterone therapy's benefits and risks, particularly for the heart.

Previous studies have produced mixed results, although differing patient populations and the research methods used might explain part of that.

For example, the new VA study excluded men with a history of heart attacks or strokes but did include those with existing heart disease.

A much-cited VA database study published in the Journal of the American Medical Association in 2013 focused on men with coronary artery disease; about 20 percent of the total study group of around 8,700 men had suffered a previous heart attack.

To date, the medical community lacks conclusions from a final clinical trial that might provide definitive recommendations.

Meanwhile, the Food and Drug Administration (FDA) issued guidance in 2015 warning physicians about overusing testosterone therapy and referring to a possible increased risk of heart attack and stroke.

A Potential Game-Changer

The new VA study is a potential game-changer due to its large size and relatively extended follow-up period.

Dr. Rajat Barua, the study's corresponding author, says the research is also crucial because of its finding that administering the correct dose is critical: Treating "low-T" but not restoring levels to standard doesn't appear to deliver many benefits, at least concerning cardiovascular risk.

Testosterone isn't prescribed to improve heart health, but it is a factor considered in many cases.

"It is the first study to demonstrate that significant benefit is observed only if the dose is adequate to normalize the total testosterone levels," Barua and his coauthors wrote.

"Patients who failed to achieve the therapeutic range after testosterone replacement therapy did not see a reduction in [heart attack] or stroke and had significantly less benefit on mortality."

Barua is affiliated with the Kansas City (Mo.) VA Medical Center. He's also an assistant professor of medicine at the University of Kansas.

The study team reviewed national data on more than 83,000 men with verified low testosterone, all age 50 or above, who received treatment in the VA between 1999 and 2014.

The researchers divided the men into three clinical groups: those who had their total testosterone levels returned to normal (Group 1), those who were treated but did not obtain healthy levels (Group 2), and those who were untreated and remained at low testosterone levels (Group 3).

Most importantly, all three groups were "propensity-matched" so the comparisons could be made between men with similar health profiles.

Unlike the earlier studies mentioned above, the researchers considered various factors that might affect cardiovascular and overall risk: age, body mass index,  chronic diseases, LDL cholesterol levels, aspirin use, beta-blockers, and statins.

The average follow-up across the groups ranged from 4.6 to 6.2 years.

The most significant difference was between Group 1 (those treated and attained normal levels) and Group 3 (those whose low testosterone went untreated).

The treated men were 56 percent less likely to die during the follow-up period, 24 percent less likely to suffer a heart attack, and 36 percent less likely to have a stroke.

The differences between Group 1 and Group 2 (those treated but did not regain normal levels) were similar but less pronounced.

Groups 2 and 3 showed little difference, except for a slight benefit in survival for those treated.

Barua and colleagues say they cannot determine the exact reasons for testosterone's apparent advantages for the heart and overall survival.

"The mechanisms for these effects remain speculative," they write.

Possible explanations, they say, could involve body fat, insulin sensitivity, lipids, blood platelets, inflammation, or other biological pathways.

More research is required, they insist, to determine how testosterone affects the cardiovascular system.

The authors also warn that "off-label" use remains problematic. Physicians should not only reach for the prescription pad because an elderly man is complaining of symptoms such as low energy and sex drive.

According to the FDA, "Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.

Examples of these circumstances include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy...none of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition."

Further studies will examine testosterone's role in mitigating the risks of heart attacks and strokes.

Possible side effects in patients will also be reviewed to determine if the risks of TRT are manageable.

Earlier studies have suggested that such treatments could be tied to sleep apnea (rough breathing), the increased growth rate of prostate cancer, and blood clots.

The literature review offers near-incontrovertible evidence that Testosterone Replacement Therapy improves heart health by relaxing the coronary arteries and helping men with heart failure to engage in physical exercise.

Testosterone HRT has also been shown to reduce BMI and control blood sugar in patients who have diabetes, which also preserves heart health and reduces mortality risk.

Single studies are often inaccurate, and the PLOS One study seems to be in that category.

Remember this the next time you hear about a single study espousing the potential dangers of TRT.

Recent research suggests that's not the case, and it will take robust evidence to prove otherwise.


Study of 83,000 Veterans finds cardiovascular benefits to testosterone replacement

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