Nelson Vergel asks for change in testosterone guidelines after negative studies

[Nelson Vergel]

A new study published yesterday and a previously published one from the Veterans Administration Hospital System (see both below) show what happens when older men are given testosterone replacement without managing potential blood level increases of factors that can affect their health.

Testosterone replacement can increase red blood cell (and hematocrit which is the total red cell volume) and estradiol production, two important factors for men's health when present in normal levels. However, due to genetic, age or other factors some men can have excessive production of both. High hematocrit and estradiol are more common in older men on testosterone since testosterone related aromatization and erythrocytosis are worse in that population. In excess, both variables have been linked to cardiovascular risks in older men. Not a single one of studies reporting higher cardiovascular risks in men on testosterone have managed either important factor.

Additionally, this latest nonrandomized study states that "No data were available on indications for T prescription, race, laboratory findings, occupational, environmental, or lifestyle factors."

Many clinics are managing hematocrit by recommending blood donation or phlebotomies to men with hematocrit over 53. They are also recommending treatment with low dose anastrozole for men with estradiol over 50 pg/mL. However, most medical practices follow basic recommendations from the 4 current guideline groups that, in my opinion, may need revision. As the summary table below shows, none mention measuring estradiol blood levels.

It is time to change the current guidelines for testosterone treatment in men to include the management of those two variables. I am also looking forward to the day when a research group will perform a good study that uses a protocol that not only gives testosterone to men but also one retests them periodically to manage dose, high hematocrit and estradiol blood levels. It should not be a difficult task.


Latest Study: Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men


Most commonly used guidelines in the United States:

https://www.endocrine.org/~/media/endosociety/Files/Publications/Clinical Practice Guidelines/FINAL-Androgens-in-Men-Standalone.pdf

 

[Nelson Vergel]

This is a press release that describes issues with a previous study from the veterans administration hospital that also fails to monitor hematocrit and estradiol (and in which the majority of veterans were not monitored after starting testosterone). When will large medical groups get it?

ExcelMale.com Identifies Major Flaws in Recently Published VA Testosterone Study




A men's health grassroots and education group advocates for better testosterone replacement therapy of veterans of the U.S. Armed Forces


Houston, TX -- (SBWIRE) -- 11/14/2013 -- Last week's Journal of American Medical Association (JAMA) published a retrospective study (1) that was performed at the Veteran's Administration (VA) hospital system. While it has long been known that testosterone replacement therapy (TRT) improves sexual function, bone density, lean body mass, and lipids, this study concluded that testosterone therapy may increase the risk of cardiovascular problems in men with a history of heart disease. It cautioned that men with pre-existing cardiovascular problems and testosterone deficiency should avoid TRT. ExcelMale.com, an education website for men, identified major flaws in this study that wrongly alarmed patients, physicians and the media.

While it is commendable that the VA hospital system collected data on the use of testosterone in over 8,000 veterans with cardiovascular disease, the study highlights deficiencies in the hospital system's testosterone management protocol.

The VA study showed that 40% of patients did not have their testosterone blood levels retested after they started testosterone. This lack of follow up contradicts a review of guidelines published on 2011 by the American College of Cardiology Foundation that The Endocrine Society, the American Association of Clinical Endocrinologists, the American Society of Reproductive Medicine, and the European Association of Urology recommendations of monitoring patients' blood analysis 3 months after initiation of testosterone therapy (2) to determine TRT dose adjustments and potential side effects.

A previously study (3) also published in JAMA in 2009 showed that men with total testosterone blood levels below 550 ng/dl had a significant increase in their risk of cardiovascular disease, while men with levels above 550 ng/dl reduced their risk by 30%. Monitored participants in the VA study were only able to increase their total testosterone blood levels to 332 ng/dl, a value considered sub-optimal by all testosterone treatment medical guidelines.

Another shortcoming of the VA hospital system's TRT protocol highlighted by the study is the lack of monitoring and managing of hematocrit (red cell volume) and estradiol (a female hormone produced in the body from testosterone). TRT can increase hematocrit and estradiol is a minority of men resulting in increased blood viscosity and cardiovascular risks as documented in the previously mentioned 2009 JAMA study (4). Fortunately, both variables can be easily managed if patients are properly monitored.

The majority of participants in the VA study used testosterone patches. Once a popular method of testosterone delivery, testosterone patches are no longer used due to their poor absorption and inconvenience. This is reflected in the VA study where most of the participants continued to have testosterone deficiency and increased cardiovascular risk.

"Publishing flawed studies only increases the current misconceptions surrounding this important therapy and unnecessarily alarms TRT patients and their physicians", said Nelson Vergel, founder of ExcelMale.com. "We encourage patients, physicians and the media to closely examine studies for misleading information that could increase barriers to life saving therapies", added Vergel.

"We urge the VA hospital system to revise their TRT protocol and to follow current testosterone guidelines. We want only the best for the men who have served our country", said Keith Willse, co-founder of ExcelMale.com.

ExcelMale.com is a peer reviewed and moderated safe platform where men can privately and securely share information and experiences about health and productivity. It is moderated daily for content and enforcement of a code of conduct and provides well organized archives of articles, forum chats, product reviews, and videos related to:

- Testosterone replacement,
- erectile dysfunction and sex drive,
- fat loss and muscle gain,
- energy boosters,
- exercise,
- nutrition,
- supplementation,
- diagnostics,
- pharmaceuticals,
- and all things related to men's health and productivity.

For more information and patient/clinician education on testosterone, visit http://www.ExcelMale.com

References:

1- JAMA. 2013;310(17):1829-1836.
2- J Am Coll Cardiol. 2011;58(16):1674-1681.
3- JAMA. 2009 May 13;301(18):1892-901.
4- JAMA. 2009 May 13;301(18):1892-901.

 

[Nelson Vergel]

Here is an interview with Dr Glueck about the small but troubling incidence (2 percent) of potential thrombosis problems in men with certain inherited clotting disorder. It seems to be worsened by higher estradiol.



Can Testosterone Induce Blood Clots and Thrombosis? Interview with Dr Charles Glueck

 

[BigJohn]

My doctor has me on Anastrozole and ask me to take aspirin daily to thin the blood. I would be interested in comments on that.

 

[BigJohn]

Also Nelson, there seem to be quite a few doctors who are reluctant to check Estradiol. I'm assuming from ignorance.