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Does TRT cause negative cardiovascular events

hogan86

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Here is a paper I just finished for school. I will break it into parts if you would like to skip. This part is history of test and TRT. Just interesting facts. Next I talk about the FDA announcement saying TRT causes heart problems and the 2 studies the cited. Then tear into those studies.


Does Testosterone Replacement Therapy Cause or
Contribute to Negative Cardiovascular Events

Testosterone is a naturally occurring hormone in all human beings and much more abundant in males. Healthy levels are often associated with being more masculine, strong and dominant. As people age many bodily functions and abilities decline. One of which is the production of testosterone in males. Within the last twenty years the business of TRT, also known as testosterone replacement therapy has exploded to over 2 billion dollars in sales annually. That does not include over the counter supplements.

Fascination and wonder of testosterone goes back over 170 years to 1849 and a zoo curator named Arnold Berthauld. He observed that when roosters were castrated, they ceased to fight, crow, or mate. Also their comb regressed. The roosters’ normal behavior and comb growth could be restored by re-implantation of the testes. Berthauld concluded that, “The testes act upon the blood, and the blood acts upon the whole organism.” Many people credit him as being the founder of modern day endocrinology.

In 1889, a 72-year old French physician named Charles-Edouard Brown-Sequard, came before the Society de Biologie of Paris, announcing that he had rejuvenated himself by injections of testicular extract from guinea pigs and dogs. Within 3 days of injection he claimed to have regained strength and intellectual power he used to have in his youth. Later it was found that the testicular extractions he was injecting did not have any androgen in it at all. His benefits were apparently all placebo effect. Still intrigue to continue research lingered among the scientific community.

In 1935 testosterone was first fully synthesized by a collaboration of Schering, Organon and Ciba, 3 major European pharmaceutical companies. After that major, widespread human trials could begin.

By 1944, Carl Heller and Gordon Myers published, “The Male Climacteric which was a major framing piece for modern day TRT. It showed that some aging men develop symptoms attributable to hypogonadism. Symptoms they listed included depression, impaired memory, easily fatigued, and loss of sexual vigor. Since blood tests were not yet developed to check for testosterone levels in the blood, Heller and Myers determined if a person was “climacteric” by testicular biopsy. They should be applauded for attempting to obtain certainty of the medical condition instead of prescribing medication just off symptoms stated by the patient which seems to be very common in current medicine
 

hogan86

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Second part. First study FDA cited...

As Heller and Myers pointed out low T can be climacteric, having long standing implications on individuals. Additional symptoms can include loss of muscle mass and strength, decreased bone density, obesity, high blood pressure and on a more cosmetic level, less body hair. They cited depression as a symptom and interesting study was done by the biological psychiatry journal trying to establish a clear correlation between testosterone and depression using 33 female to male transsexuals (Kranz, G. S., 2015). They were administered testosterone as part of their transition and it was found to increase serotonin reuptake transporter (SERT) in the amygdala, caudate, putamen, and median raphe nucleus.

In a study published by the Journal of Clinical Endocrinology & Metabolism using 108 men over the age of 65, it was discovered, when supplementing testosterone the biggest bone density improvements were found in men that had the lowest T levels prior to treatment. (Snyder, P. J., 1999)

With many apparent benefits to TRT the industry has grown tremendously, and so has the scrutiny by governing bodies. January of 2014 the FDA cited two research studies when it stated they were “investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products” (FDA, 2014). Most of the FDA attention is focused on manufactures of patented delivery systems like, gels, creams and patches that used high dollar aggressive marketing campaigns aimed directly at consumers. It did not take long for the lawsuits to pile up and there are now over 7000 lawsuits regarding the prescription of testosterone and its reported risk on cardiovascular health and risk of death.

The first study the FDA cited was done by the Veterans Administration and included 8709 men, average age about 62 (Vigen R., 2013). The participant`s medical history was checked and approximately 20% had a history of myocardial infarction, 50% had diabetes and over 80% had coronary artery disease detected by coronary angiography. Because of so many preexisting conditions the patients were not randomized and instead selectively placed in categories either receiving TRT or not to try and evenly distribute the preexisting conditions between both groups. This study found TRT increased negative cardiovascular events s by 5.8%, that is significant, but this study has some major flaws.

Of the patients prescribed testosterone therapy, only 60% had testosterone values checked after starting treatment. Among these patients, the baseline total testosterone level was 175 (ng/dL) and increased to 332 (ng/dL). This is still a very low level at the bottom of an established range. These participants were not given a sufficient dose for them to attain a therapeutic range, yet they are labeled as TRT patients. A total testosterone level of 332 (ng/dL) is a level at which others studies have cited negative health risks associated with low T.

In the conclusion of this study they even mention their findings conflict with another study “Low Serum Testosterone and Mortality in Male Veterans” (Shores, M.M., 2006), in which investigators noted a 39% reduction in mortality risk among patients treated with testosterone therapy.
 

hogan86

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Second study FDA cited and conclusion. If anybody wants links for the citation to read the studies just PM me or post up. I have a bunch of references so you can read the actual studies.

The second study used data gathered from various medical databases for events that happened between 2006 - 2010 involving men taking TRT and also recorded any cardiovascular events (Finkle, W., 2014)

Preexisting conditions, setup of studies being either randomized or selectively placed, double blinded and many other variables were not apparent or clear in this study, which all reduce the confidence level of the findings, regardless of the outcomes.

Lab results were not able to be obtained, so again these men are labeled TRT users but we don`t know what their actual blood levels were. The widely accepted range for total testosterone is roughly 300-1200 (ng/dL). The purpose of using exogenous testosterone is to replace what the body is no longer producing at sufficient levels and bring that person back into a healthy range which should be someplace around the 50% tile or about 750 (ng/dL). Furthermore many men discontinued treatment within 90 days but are still labeled TRT patients for the follow up period of 180 days.

For all ages combined there was an increase of 1.27 heart attacks per 1,000 patients that took TRT. That is an increase of .127% (table A). Is that statistically significant? Is that margin possibly just human error while setting up the research?

For older men over the age of 65 in the study the rate of heart attack more than doubled. But we are also talking about 20 cases of MI in men over 65 that have taken TRT. Twenty cases out of the remaining pool does not really qualify as a large scale study so more work needs to be done on the older population.

Interestingly there are no studies for men under 40 with healthy testosterone levels, either naturally, using TRT, or just using OTC supplements showing an increased risk of negative cardiovascular events. If there is in fact a real correlation between TRT and heart illness it does not seem to effect men younger than 40.

The FDA has since updated their guidance as of March 2015 and now cautions that “prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone” (FDA, 2015).

While this guidance remains in place doctors freely continue to prescribe testosterone for patients with low T. The spotlight of negativity and pressure remains on AbbVie Inc. the maker of AndroGel (topical gel), Actavis the maker of Androderm (skin patch) and Auxilium Pharmaceuticals the maker of Testim (topical gel). While others are named in the class action lawsuits, these three seem to have pushed the most aggressive marketing and have been targeted heavily.

BioMed Central did a systemic review, a cumulative study of TRT studies. 27 trials were included. Criteria was, must be placebo controlled, randomized, 12 weeks or more of TRT and data collected on cardiovascular events (Xu, L., 2013).

The researchers determined TRT increased the risk of negative cardiovascular events by 2%, with a 95% confidence interval. What could be considered a bigger finding by the researchers was that “The effects of testosterone on cardiovascular-related events varied with source of funding.” Overall and particularly in trials not funded by the pharmaceutical industry, exogenous testosterone increased the risk of cardiovascular-related events, with corresponding implications for the use of testosterone therapy. If a study receives funding from outside the pharmaceutical industry does it mean they can`t have a bias that goes against the bias of the drug makers?

In an industry where billion dollar drugs are the goal there will always be disagreements and bias on both sides as to the efficacy of specific drugs and treatments. Lawsuits will continue as common place but certain things are not disputed. Negative cardiovascular events can be reduced by healthy lifestyle, exercise and proper nutrition. Consumers looking to limit possible negative cardiovascular events and/or maximize the benefits of TRT (if they choose to use) should first start with the low risk, nonprescription ideas associated with a healthy lifestyle.
 

Animalgear

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I appreciate the study but like you said it has flaws. I think the benefits of trt will always outweigh the detriments...and we must work to stay healthy regardless.
 

eatsle3plift

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I appreciate the study but like you said it has flaws. I think the benefits of trt will always outweigh the detriments...and we must work to stay healthy regardless.
I agree with you, I think the benefits outweigh any negatives
 

MRX MRX

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My cardio has finally caught up with my ten pound muscle trt gain.
I'm mostly an endurance athlete. Sprint triathlons.

Shocked to see my latest blood pressure reading though
 

GunRunner

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I went from having a mild cardiac event and being put on different drugs to getting off of all drugs, losing weight fat while on TRT, which is the only prescribed drug I am now on.
 

jet2000

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Nice post thank you, I think its great to know the negatives so you know what you opt for
 

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