JAMA Article: Association of T Therapy with Mortality, MI, and Stroke

[2Sox]

Just a heads-up on the Nov. 6, 2013 article in JAMA. My allergist handed it to me yesterday. Tough to wade through but at first skimming, it seems to be a "study" not an experiment with a control.

I hope LowTMike and others with clinical backgrounds chime in on this. The title of the article alone doesn't give TRT a good name.

Full Title:
Association of Testosterone Therapy with Mortality, Myocardial Infarction and Stroke in Men with Low Testosterone Levels.

[gatornate97]

I'd definitely like to hear what others with the medical background have to say about this "study"

[ppj]

I'd definitely like to hear what others with the medical background have to say about this "study"

This is my very first post...
It's being debunked already.
Search .
UPDATE: Is Testosterone Therapy Dangerous? Dr. Mark Richards in Washington, DC Debunks the Myth

[Metalject]

LowTestosterone.com Debunks Latest Long-Term Low Testosterone Study
The Journal of the American Medical Association misleading reports

HOUSTON, Nov. 8, 2013 /PRNewswire/ -- The Journal of American Medical Association relayed that testosterone treatment may increase the risk of cardiovascular ailments. The basis of the study cautioned that men with pre-existing cardiovascular ailments might need to avoid testosterone. The holes in this study are so large it is beyond comprehension that any journalist or reporter could take the study seriously.

It's been long understood that untreated prolonged low testosterone can increase the risk of cardiovascular incidence. Although prescribed testosterone, the men in this study remained at a low level state. Nearly half were never retested during treatment. Recent data shows that men with total testosterone below 550 ng/dl increase their risk of cardiovascular incidence, while men 550 ng/dl and above reduce their risk by 30%. Most participants in this study held their testosterone levels at 332 ng/dl.

Since recommended guidelines of treatment were not followed, there were no reports showing measurements of estradiol or hematocrit. High levels of estradiol or hematocrit can increase cardiovascular risk. However, both estradiol and hematocrit are easily managed when proper treatment guidelines are followed.

The study also showed the majority of participants used testosterone patches. Once a popular method of testosterone delivery, testosterone patches are no longer used when proper treatment guidelines are followed. Patches are highly inefficient in terms of optimizing testosterone, resulting in continued hypogonadal symptoms and increased cardiovascular risk.

Perhaps the most startling piece of the study that was missed altogether or largely ignored by most reports was the rate of reported cardiovascular events. Of those taking testosterone, 10% experienced a cardiovascular event. Of those not taking testosterone, 21% experienced a cardiovascular event. The rate of mortality was greater in those who did not take testosterone.

Studies of this nature are difficult to take seriously when their parameters do not meet standard treatment guidelines. Such studies might parallel this absurd example: Shooting a man who was given testosterone, then blaming the testosterone rather than the gaping bullet hole for his demise.

LowTestosterone.com Debunks Latest Long-Term Low Testosterone Study -- HOUSTON, Nov. 8, 2013 /PRNewswire/ --

[Far from massive]

As is so often the case you can ignore or manipulate factors in a "controlled study" to achieve whatever results you desire.

So many doctors prescribe TRT and do not use AI's when needed to control estro, do not use donation of blood or other methods to control BP, and most importantly do not do evaluate patient attitude and physical condition prior and during treatment to ensure that all steps needed to maximize benefits and minimize dangers are being prescribed and followed.

The only good thing about this study, is that a dozen more studies will likely focus on this exact problem, since so many "doctors" are jumping on the bandwagon and just writing scripts for Test as an easy way to pay the rent with total disregard for benefit vs risk and how to maximize it. If this does not happen soon Testosterone therapy will soon be viewed the same as Oxycontin. Both are very valuable tools when used as directed but both have huge potential for misuse and abuse if used improperly.

FFM

[2Sox]

Metalject,

Thanks for being on top of this. Glad to see that Lowtestosterone.com got right on it.

[LowT Mike]

Unfortunatly This type of article sets us back in this field all due to poorly gathered data from suboptimal therapies done by untrained doctors. It only takes 1 bad apple to spoil the bunch. These reports are not controlled clinical studies but rather articles of gathered census data that you are hearing. BIG DIFFERENCE when deciding accuracy of findings. For every 1 article that shows negative results of TRT we can show you 10 medical studies that say the opposite.

Many things give off red flags when reading this article.

If you read the article closely and do a little math you were find only 240 men out of 6000 that were ill with heart problem and had angiograpy 2.4 years before they died or suffered more heart problems. Ms.Bahar Gholipour the staff doesn't make clear how many actually died out of the 6000. She does at the end of the article admit she doesn't have a clue as to the problems if any that may be encounted by healthy men and how many are helped by testosterone therapy

This is a bad bad study and should of never been published. There are many ACCURATE clinical studies that show high serum testosterone is directly correlated with reduced risks of cardiovascular events in elderly men. When treatment is done properly you’ll generally see cholesterol improve, blood pressure improve and higher heart ejection fraction.

Ref. http://content.onlinejacc.org/articl...icleid=1146860

The doctors that monitored these men in this particular article who had a cardiovascular event made many pitfalls within their treatment and the men who had cardiovascular events were already in a morbidly high risk state for such an event.

First in the vast majority of the patients they only got their testosterone levels to the bottom of the reference range (332 mg/dL). This is by no means optimal. We aim at total testosterone blood levels above 600 ng/dL). These men are considered to still be hypogonadal. Hypogonadism has been reported to increase cardiovascular events. Under treating men with prior history of heart disease may be worse than not treating them at all. Most of these men with history of heart disease remained hypogonadal even on testosterone treatment.

Also, They were not correctly monitored for hematocrit and estrogen which is most important during testosterone treatment. Common knowledge by most trained doctors. Hematocrit over 55% and high estrogen you run the risk of blood clot, DVT, stroke and heart attack. Very easy to treat for both of these. A blood draw a couple times a year lowers hematocrit and a safe anti-estrogen medication is prescribed if estrogen is elevated.

Ref. Circulating estradiol and mortality in men with systoli... [JAMA. 2009] - PubMed - NCBI

The majority of the patients were also using testosterone patches. (testosterone patches are no longer used since they are sub-optimal therapy). This administration method is 8-10 years out dated. Patches can cause an imbalance in DHT metabolites that has also been linked to cardiovascular events. Luckily, the VA hospital system is probably now not mandating the use of patches as the main option for testosterone replacement in their medication formularies.

Article findings--Of 7486 patients not receiving testosterone therapy , 681 died, 420 had MIs, and 486 had strokes. So, 21 percent of men not using testosterone had a cardiovascular event.
Among 1223 patients receiving testosterone therapy, 67 died, 23 had MIs, and 33 had strokes. So, 10 percent of men using testosterone had a cardiovascular event.
40 % were not retested for testosterone so no one knows if they were taking testosterone and what their levels were after they started therapy.

The treatment of these men clearly did not follow recommended guidelines. Ill let you now draw your own conclusion.

Ref http://stg.jfponline.com/pdf/5912/5912JFP_ClinInq3.pdf

[johnhenry]

Metalject,

Thanks for being on top of this. Glad to see that Lowtestosterone.com got right on it.

I received this from Life Extension - addresses it well I think:-

Response to Media Reports
Associating Testosterone Treatment
With Greater Heart Attack Risk
Headline news stories on November 5, 2013, parroted a study proclaiming that aging men using testosterone drugs suffer greater heart attack risk.
Life Extension® immediately recognized errors in this anti-testosterone study that render its findings meaningless.
This study was designed by physicians who apparently don't know how to safely restore testosterone levels in aging men.
The media's portrayal of this flawed study will discourage aging men from properly restoring their testosterone levels. To help spare the lives of testosterone deficient men, we have prepared an extensive rebuttal to this erroneous report.
For those who choose not to read our extensive rebuttal, I've prepared the following brief summary:
1) In order to protect against heart disease, total testosterone blood levels need to be raised higher than 500–550 ng/dL. Life Extension believes that optimal youthful total testosterone is in the 700–900 ng/dL range.
The men enrolled in this flawed study only boosted their mean total testosterone levels to 332 ng/dL. Previous studies show this low testosterone level (332 ng/dL) is associated with an increased heart attack risk compared with levels above 500–550 ng/dL.
2) The men in this study were not properly individually dosed and monitored, which explains why the testosterone treatment they received failed to restore their blood testosterone levels to anywhere near cardio-protective ranges.
3) Estradiol (an estrogen) blood levels were not reported in this study used to discredit testosterone drugs. A subset of aging men, often with increased visceral body fat (body fat around the internal organs of the abdominal cavity), have a tendency to convert testosterone into excess estrogen. This excess estrogen may alter the balance of anticoagulant and procoagulant (clotting) factors in the blood, and potentially enhance the risk of heart attack and stroke. Any man treated with testosterone drugs should also have his estradiol blood level tested to ensure that the testosterone is not excessively converting to estrogen. If estradiol increases excessively, then low-dose aromatase-inhibiting drugs (such as 1 mg/week of anastrozole [Arimidex ®]) can be prescribed to reduce the conversion of testosterone to estrogen.
A subgroup of overweight men with excess visceral body fat treated with testosterone in this study would be expected to excessively convert (aromatize) their testosterone into estrogen, which may help explain why more men in the testosterone group suffered a greater percentage of heart attacks.
Research published in 2013 shows profound cardiovascular benefits in response to higher testosterone levels (in men). The media conveniently ignored these positive reports and narrowly focused on the egregiously flawed study published in the Journal of the American Medical Association (JAMA).
Based on many published studies, Life Extension has recommended for decades that aging men restore testosterone to a youthful range. We've always warned that for some men restoring one's testosterone to more youthful levels could create excessive levels of estrogen, which is readily detectable by blood testing and reversible using aromatase-inhibiting therapies.
What's most frightening is that most mainstream doctors today are blindly prescribing testosterone drugs and omitting any kind of estrogen testing. This creates a very dangerous environment for men who excessively convert their testosterone into excess estrogen!
To read Life Extension's full rebuttal to this flawed study used by the media to discredit testosterone therapy , just click here.
For longer life,

William Faloon