Testosterone Drug Heart Risks
The findings of this latest study come as debate over the potential heart risks with testosterone replacement therapy continues, as several recent studies have suggested that certain men may be more likely to experience a sudden heart attack, stroke, blood clot or death while using the popular low T drugs.
On March 3, the FDA issued a drug safety communication announcing that it was placing new warnings on all testosterone drugs, which indicate that there is evidence of a possible link between testosterone drug and heart problems. The agency also urged doctors not to prescribe testosterone to patients who had not been confirmed as having hypogonadism through serum testosterone blood tests.
The warning came after the publication of several studies that suggest certain men may be more likely to suffer testosterone heart problems after being placed on testosterone therapy. Those findings also raised questions about the widespread off-label use of TRT for so-called lifestyle reasons to combat the natural effects of aging.
In November 2013, research published in the Journal of the American Medical Association found that older men who began taking testosterone drugs following coronary angiography were more likely to suffer cardiovascular events, such as a heart attack, stroke or death.
Interpreting Changes In Serum Psa Levels During Testosterone Replacement Therapy
Data from Intervention Studies of Testosterone Replacement in Young and Older Men With Hypogonadism
Lowering of serum testosterone concentrations by withdrawal of androgen therapy in young men with hypogonadism is associated with a decrease in serum PSA levels . Similarly, treatment of men with BPH with a 5-alpha reductase inhibitor, finasteride, is associated with a significant lowering of serum and prostatic PSA levels .
|The presence or history of prostate cancer|
|1.||Baseline PSA 4 ng/mL or a palpable abnormality of the prostate without urological evaluation to rule out prostate cancer|
|2.||Evidence of hereditary prostate cancer in men, defined as the presence of 3 or more affected relatives within a nuclear family, or occurrence of prostate cancer within each of 3 generations , or the presence of 2 relatives affected at an early age of 55 y or less|
|3.||Severe symptoms of lower urinary tract obstruction as indicated by IPSS or AUA symptoms core of 21 or greater|
Use of Other Prostate Markers for Monitoring
Does Testosterone Cause Prostate Cancer
As men age, their testosterone levels can fall: by one estimate, 39% of men aged 45-85 have blood testosterone levels considered low . Many have no symptoms, but some men may experience symptoms such as low mood, low energy, weight gain, and low sex drive, leading them to seek evaluation and treatment. In consultation with their doctor, they may consider testosterone supplements. Testosterone supplementation is becoming more common: between 2000 and 2011, the number of prescriptions of testosterone filled by U.S. pharmacies increased tenfold.
What does this have to do with prostate cancer? Prostate cancer is related to male hormones, and medications that block testosterone are used to treat certain types of prostate cancer. Men taking testosterone supplements might worry whether they are putting themselves at risk for prostate cancer in the future. Patients who have been diagnosed with prostate cancer and who previously took supplements may wonder: did the testosterone cause my cancer?
Fuel for existing prostate cancer
In his 2018 book The Virility Paradox , PCFs President and CEO, Dr. Chuck Ryan, wrote extensively on the complicated role of testosterone in the human body. He notes that testosterone does not cause prostate cancer, but it can fuel prostate cancer that already exists. Biologically, there is a difference between initiating cancer vs. promoting cancer once it has already started. Testosterone does the latter for prostate cancer.
Talk to your doctor
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Are There Any Risks Linked To Trt
Experts are still trying to fully understand the risks and side effects of TRT. According to Harvard Health, many existing studies have limitations, such as being small in size or using larger-than-usual doses of T.
As a result, theres still some debate over the benefits and risks linked to TRT. For example, its been said to both increase and decrease the risk of certain types of cancer.
A 2016 article in the journal Therapeutic Advances in Urology suggests that some of these conflicting views are the result of overzealous media coverage, especially in the United States.
Before trying TRT, its important to sit down with your healthcare provider and go over all the potential side effects and risks. These may include:
How Much Does Trt Cost
The costs of TRT varies based on what type youre prescribed. If you have health insurance and need TRT to treat a health condition, you likely wont pay the full cost. The actual cost may also vary based on your location and whether theres a generic version available.
Generally, you can expect to pay anywhere from $20 to $1,000 per month. The actual cost depends on a range of factors, including:
- administration method
- whether theres a generic version available
When considering the cost, keep in mind that TRT simply boosts your T levels. It wont treat the underlying cause of your low T, so you may need life-long treatment.
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Why Testosterone Replacement Therapy May Not Affect Enlarged Prostate
Researchers are still studying the link between testosterone and the prostate. However, there are a few reasons why TRT may have no effect on prostate size or enlarged prostate symptoms. While its true that the prostate increases in size during puberty, serum testosterone in your blood as you get older may not have much influence on your prostate. Several researchers believe that blood testosterone has little effect on the prostate, only the testosterone inside the prostate, which doesnt seem to change easily with testosterone administration.
Also, for those who noticed improvements, there may be an explanation for that as well. Its not entirely clear what causes an enlarged prostate. However, some believe low nitric oxide levels in the body may be partially to blame. Nitric oxide may help with the process of relaxing smooth muscles. How does this relate to testosterone? Many believe testosterone affects nitric oxide production in your body.
So, while research continues for testosterone and enlarged prostate, there may be several explanations to why testosterone replacement therapy later in life does not seem to cause or worsen enlarged prostate.
If youre experiencing symptoms of low testosterone, our treatment providers may be able to help. Our team can help find underlying causes of your symptoms and work with you to create customized treatment plans to help you feel great again.
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The study looked at the testosterone levels and prostate sizes of men in an isolated Bolivian tribe called the Tsimane. They found that the men there had relatively low levels of testosterone throughout their lives, and that they also had significantly smaller prostates and a reduced risk of BPH throughout their lives.
Researchers found that Tsimane men with higher levels of testosterone tended to have larger prostates. By comparison, about 90% of all men in the U.S. will experience prostate enlargement at some point in their lives, with 40% requiring medical treatment, the researchers said.
Basically, these guys taking testosterone replacement therapies are entering themselves into an uncontrolled experiment, study co-author Benjamin Trumble said in a university press release. And this happened to women with estrogen replacement therapy from the 1980s to the early 2000s. And then the Womens Health Initiative study came out and showed that all these women were putting themselves at risk for breast and other cancers.
Trumble said that other studies have shown a potential link between testosterone and prostate cancer as well.
The studys senior author, Michael Gurven, said American men needed to be cautious when trying to use testosterone drugs to combat the natural lowering of testosterone levels caused by aging.
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Studies Show Prostate Size And Enlarged Prostate Symptoms Arent Associated With Testosterone Replacement Therapy
There have been many studies to research whether testosterone replacement therapy affects the risk for BPH. Many have also shown theres no change in enlarged prostate after beginning testosterone.
One 2015 study out of the University of Illinois looked at data from 1995 to 2015 to see if TRT might cause or worsen BPH or LUTS. The study looked at men with low testosterone and mild LUTS. Those taking TRT noticed either no change in their symptoms or even a slight improvement. This includes LUTS as well as their International Prostate Symptom Scores . The researchers also found no significant increase in prostate size after beginning testosterone therapy.
Some Men May Notice Symptom Improvement with Testosterone Replacement Therapy
In other studies, some men have even noticed their enlarged prostate symptoms get better after beginning testosterone. One study looked at patients with metabolic syndrome, LUTS, and low testosterone levels. The researchers found that the mens LUTS symptoms improved after starting testosterone. They theorized that testosterone replacement therapy may have helped reduce some of the risks for inflammation that are common in those with metabolic syndrome, which, in turn, helped reduce prostate inflammation and symptoms of an enlarged prostate. Therefore, some men may even benefit from testosterone if they have both low T levels and symptoms of enlarged prostate, though research is still ongoing.
Epidemiological Data On The Relationship Between Serum Testosterone Levels And Prostate Cancer
None of the studies that measured DHT and estradiol found higher levels of these hormones in cases than in controls. SHBG levels have also not been significantly different between cases and controls in a majority of studies with the exception of one study .
The problems inherent in epidemiological association studies have been highlighted recently by the firestorm that erupted after the release of data from the Women’s Health Initiative on the effects of estrogen. The data from this and other randomized, controlled, intervention trials have contrasted sharply with the data from previous epidemiological studies that had reported lower cardiovascular mortality in estrogen users. The results of the Women’s Health Initiative and the HERS emphasize the need for definitive, randomized, placebo-controlled studies of testosterone supplementation in older men.
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When You Need Testosterone Treatmentand When You Dont
Most men have problems with erections from time to time. But some men have erectile dysfunction, or ED. This is when it is difficult to get or keep an erection thats firm enough for sexual intercourse.
If you have ED, you may think that testosterone treatment will help. Testosterone is a male sex hormone. After age 50, mens levels of testosterone slowly go down and ED becomes more common. But unless you have other symptoms of low testosterone, you should think twice about the treatment. Heres why:
Testosterone Replacement Therapy And Benign Prostatic Hyperplasia/benign Prostatic Enlargement
There seems to be little doubt that the treatment with testosterone of a young hypogonadal male leads to significant growth of the prostate. This was reported in hypogonadal males with primary hypogonadism who have significant growth in prostate volume with TRT.5 Thirteen men between 25 and 32 years old with Klinefelter’s syndrome were treated intramuscular testosterone and found to have an increased in prostate size from 9.3 to 19.0 ml, compared with no change in the control volume of 18.7 ml . Similarly, Behre et al.22 demonstrated increased prostate volume and prostate-specific antigen levels in hypogonadal men to those seen in aged-matched normal men after treatment with TRT.
Most studies, however, have shown no effect of exogenous androgens on PSA or prostate volume for older hypogonadal males.23 In an RCT of 44 late-onset hypogonadal men, Marks et al.14 found that those treated with TRT did not have a significant increase in prostate tissue levels of testosterone or DHT, despite having significantly increased levels of serum testosterone. More recent evidence from placebo-controlled studies of hypogonadal men receiving androgen therapy, indicate that the differences between those men receiving testosterone and those on placebo were insignificant in regards to prostate volume, PSA and BOO.24
These concepts are an important, direct challenge to those traditional safety concerns regarding TRT and BPH outlined above.
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What Does It All Mean
There does not appear to be a link to higher levels of testosterone and increased risk of prostate cancer. The proposed saturation model appears to be an appropriate explanation for the benefit of castration explained by Huggins yet contradicted by the later studies.
Caution should be exercised when considering testosterone replacement therapy for any patient much less in those with other risks.
When Should You Consider Testosterone Treatment For Ed
If youve had trouble having erections for three months, talk to your doctor. He or she will ask about all your symptoms and give you a physical exam. Symptoms of low testosterone can include less of a sex drive, loss of body hair, breast growth, needing to shave less often, a drop in muscle size and strength, and bones that break more easily.
If you have some of these symptoms, your doctor may have you get a blood test to measure your testosterone levels. The blood test should be done more than once. It is best to do it in the morning when testosterone levels are highest.
If the tests show that you have low testosterone levels, your doctor should look for possible causes. For example, the low levels might be caused by a problem in the pituitary glands.
If no other cause is found, you can try testosterone treatment.
This report is for you to use when talking with your health-care provider. It is not a substitute for medical advice and treatment. Use of this report is at your own risk.
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Other Uncertainties Related To Testosterone Supplementation In Older Men
Although this review focused on issues related to potential prostate adverse events and monitoring during testosterone replacement of older men, a number of other uncertainties are related to the issue of testosterone supplementation, which have been discussed in other recent reviews , but were not covered in this systematic review. There is no consensus on numerical thresholds of serum total or free testosterone concentrations, which should be used to define androgen deficiency in older men. However, most authorities compare levels with those in healthy men 20 to 40 or 45 years of age. The beneficial effects of testosterone replacement in older men on health-related outcomes are yet to be demonstrated. We do not know the optimum target level of serum testosterone that should be achieved during testosterone replacement and that would maximize benefits and minimize the risks of testosterone supplementation. The role of androgen supplementsDHEA and androstenedionewhich are widely available in health food stores, remains largely unknown.
Does Low Testosterone Increase The Risk Of Prostate Cancer
While it is a common belief that high testosterone levels increase prostate cancer risk, newer research is showing the opposite. Research that became available over the last 20 years, has shown a correlation between low testosterone and higher prostate cancer risk, according to a recent talk given by Dr. Mohit Khera, a leading researcher at Baylor College of Medicine.
A quote from a 2016 review article, on testosterone and prostate cancer, summarizes our current understanding well: The link between low endogenous testosterone levels and prostate cancer has been extensively studied. Men with low endogenous testosterone levels have increased rates and severity of prostate cancer at diagnosis.
Here are a few of the groundbreaking studies done in this area:
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Testosterone Replacement Therapy And Lower Urinary Tract Symptoms
Lower urinary tract symptoms in men are traditionally considered the ultimate clinical expression of BPH/BPE due to BOO. Nonetheless, LUTS are a set of subjective and objective symptoms, the causes of which are multifactorial and generally not disease specific. In fact, the natural history of LUTS is complex, and symptoms can wax and wane with time even without any treatment.32
Although there is no double-blinded RCTs to date, current studies seem to demonstrate that either TRT does not worsen LUTS or that it may, in fact, improve symptoms. This is not a new concept as early as 1939, Walther and Willoughby33 used testosterone to treat 15 men with BPH with the improvement in their LUTS over 2 years although this treatment seemed to have been dismissed or forgotten for some time.
A recent retrospective review of a prospective database by Pearl et al.34 demonstrated a lack of any relationship between IPSS and ADT in 120 men with a median follow-up of 1 year. In fact, there were just as many men who had improvement of their LUTS as who had worsening of LUTS. Furthermore, the duration of treatment did not have any effect on IPSS.
Ko et al.36 investigated a small subset of 17 patients receiving TRT with moderate LUTS and a Qmax> 10 ml s1, who were not taking any BPH medication, and found that their IPSS was significantly improved although mean change was minimal . There was no change in Qmax or post void residual .
Monitoring Psa Levels In Older Men Receiving Testosterone Replacement
Older men considering testosterone supplementation should undergo digital examination of the prostate, evaluation of risk factors for prostate cancer, and symptom scores for BPH using either the AUA or the IPSS questionnaire, and a baseline PSA measurement . As a general rule, men with a previous history of prostate cancer should not be given androgen supplementation, and those with palpable abnormalities of the prostate or PSA levels > 4 ng/mL should undergo urological evaluation . We recognize that some men with hypogonadism who have had a radical prostatectomy for prostate cancer and undetectable PSA levels for several years may be cured and may be candidates for testosterone replacement therapy. Because testosterone administration could potentially promote the growth of residual cancer, replacement therapy in this setting should only be considered after urological consultation and after a thorough discussion of the potential risks. If replacement therapy is provided to such men, PSA levels must be monitored more frequently. Men with BPH and mild to moderate symptoms of can be safely treated with testosterone replacement with careful follow-up.
|Detection of a prostatic abnormality on digital rectal examination|
|5.||An AUA or IPSS prostate symptom score of > 21|
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