Unless you have been imitating Rip Van Winkle for several years, you are aware that Testosterone Replacement Therapy (TRT) has exploded in the last decade.
However, there have been very few studies that have examined the long-term effects of taking testosterone on cardiovascular health and other vital functions concerning the health effects on men receiving the treatment.
But that has changed.
Recently, investigators from Brigham and Women's Hospital (BWH) report the results of Testosterone's Effects on Atherosclerosis Progression in Aging Men (TEAAM) trial in the Journal of the American Medical Association (JAMA).
The three-year study finds that testosterone administration had no effect on the progression of hardening of the arteries in older men with low to low-normal testosterone levels and did not significantly improve sexual function or health-related quality of life.
Shehzad Basaria, M.B.B.S., MD, from Harvard Medical School in Boston, and colleagues studied the effect of testosterone administration on atherosclerosis progression in older men.
Three hundred eight men aged 60 years or older (patients had a mean age of 67.6 years), with low or low-normal testosterone levels, volunteered and were treated with up to 7.5 g of 1 percent testosterone (156 men) or placebo gel packets (152 men) daily for three years.
In testosterone-treated patients, doses were adjusted periodically to achieve testosterone levels between 500 and 900 ng/dL.
Additionally, 42% of participants had hypertension, 15% had diabetes, 15% had cardiovascular disease, and 27% were obese.
The researchers assessed sexual function using the International Index of Erectile Function, a validated 15-item questionnaire that assesses five domains of sexual function (erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall sexual satisfaction).
They used the Medical Outcomes Study 36-item short-form health survey (SF-36) to assess health-related QOL.
"The results of this trial suggest that testosterone should not be used indiscriminately by men," said Dr. Bhasin, director of BWH's Research Program in Men's Health: Aging and Metabolism and director of the Boston Claude D. Pepper Older Americans Independence Center at BWH.
He added that "We find that men with low and low-normal testosterone are unlikely to derive benefits regarding sexual function or quality of life -- two reasons why men may seek testosterone therapy.
And although we find that testosterone did not affect the rate of hardening of the arteries, we need long-term data from large trials to determine testosterone's effects on other major cardiovascular events."
No Significant Difference
The researchers also observed no significant difference in the rate of change in intima-media thickness (a measurement of the thickness of the innermost two layers of the wall of an artery...0.010 mm/year in the placebo group versus 0.012 mm/year in the testosterone group; P = 0.89) or in the rate of change in the coronary artery calcium score, which is a cardiac CT scan for coronary calcium in a non-invasive way of measuring calcified plaque in the coronary arteries — the vessels that supply oxygen-containing blood to the heart muscle...(41.4 versus 31.4 Agatston units/year; P = 0.54).
In the individuals assigned to receive testosterone, changes in intima-media thickness or calcium scores had no link with a difference in testosterone levels.
There was no significant difference between-group sexual drive, erectile dysfunction, sexual function ability, partner intimacy, or health-related quality of life.
"Our research shows convincingly that testosterone therapy does not affect the rate of atherosclerosis progression, but we need much larger, randomized trials to determine if testosterone treatment impacts heart attack and stroke risk," Bhasin told MedPage Today.
He added that if this is the case, the mechanism does not appear to be through the treatment's impact on atherogenesis.
"Testosterone may be affecting some other mechanism, such as plaque stability or clotting within the blood vessel," he said.
"Because this trial was only powered to evaluate atherosclerosis progression, these findings should not be interpreted as establishing the cardiovascular safety of testosterone use in older men," the authors write.
"Our study has important implications for clinical practice, and for older men who are seeking testosterone therapy," said Bhasin.
"Many men, as they age, experience a decline in testosterone and sexual function and vitality.
But our study finds that taking testosterone, when levels are in the low to the low-normal range, may not improve sexual function or quality of life."
The study was supported by Solvay Pharmaceuticals/Abbvie Pharmaceuticals, which provided testosterone and placebo gel.
Testosterone, a hormone primarily secreted by the testicles, plays a vital role not only in male reproductive tissues but also in muscle growth, bone mass, and body hair.
As men get older, their testosterone levels naturally decline -- on average by 1 percent a year after age 40.
Previous studies that have aimed to examine rates of cardiovascular events in men taking testosterone have reported conflicting results but have raised concerns that testosterone therapy might increase a person's risk of a heart attack or stroke.
Atherosclerosis, or the buildup of plaque in the arteries, is a critical risk factor for such cardiovascular events.
But Cardiovascular Safety for TRT Remains an Open Question
While earlier studies examining the impact of TRT on cardiovascular disease (CVD) risk in older men have been mixed, the TEAAM trial was not powered to weigh in on testosterone's effect on CVD events in this population, the researchers warned.
As a result, the findings should not be interpreted as establishing the treatment's safety in older men, they emphasized.
The TEAAM trial was designed to examine atherosclerosis progression and not cardiovascular events — further studies will be needed to determine the cardiovascular safety of testosterone use in older men.
The research team also notes that comparing patients using statins to those who are not could be another important direction for future studies.
Baseline characteristics among the treatment and placebo groups were similar: mean patient age at randomization was 67.6 years, 42% of participants had hypertension, 15% had diabetes, 15% had cardiovascular disease, and 27% were obese.
The authors reported that the rate of change in the CAC score was 41.4 Agatston units/year in the placebo group and 31.4 Agatston units/year in the testosterone group for an adjusted mean difference of 10.8 Agatston units/year (95% CI 45.7 to 24.2, P=0.54).
Study limitations included the high rate of loss to follow-up and the fact that the effectiveness of participant blinding was not assessed.
Bhasin said the failure to show a positive impact on these secondary endpoints has significant implications for the use of TRT in relatively healthy middle-aged and older men.
He said the dramatic rise in TRT use among relatively healthy, aging men with borderline low testosterone levels over the last decade had been primarily driven by the desire to improve sexual function and QOL.
"Testosterone is being used indiscriminately, and it shouldn't be," he said.
"Many middle-aged and older men are seeking this treatment to address sexual symptoms or to improve their quality of life. Our study clearly showed that the treatment has little impact in men whose testosterone levels are near normal."
He noted that although several large, randomized trials evaluating TRT in older men are nearing completion, including the NIH's Trial, they are not designed to determine CVD risk.
"We need a TRT test with cardiovascular event rate as the primary outcome, and it needs to happen fairly quickly," he said.
Testosterone Treatment and Coronary Artery Plaque Volume in Older Men With Low Testosterone.
Contact Us Today For A Free Consultation
- MOTS-c Therapy To Improve Body Composition - December 15th, 2022 [December 11th, 2022]
- Punicalagin: A powerful Testosterone Booster - January 17th, 2023 [November 24th, 2022]
- Blocking Testosterone to Defeat Melanoma - September 9th, 2022 [August 11th, 2022]
- Stomach Inflammation: Another Ailment That Testosterone Can Stop in its Tracks - December 19th, 2022 [August 3rd, 2022]
- Study Finds that Testosterone Boosts Memory for Uncontrolled Diabetics - July 11th, 2022 [June 24th, 2022]
- Causes of Low Libido - Could It Be Low-T? - June 24th, 2022 [May 30th, 2022]
- The Evolutionary Effects of Testosterone on Human Society - November 24th, 2021 [September 20th, 2021]
- More Sex: A Better Way to Boost Your Testosterone Levels - October 30th, 2021 [September 7th, 2021]
- Men Want to Know – Free Testosterone versus Total Testosterone - January 2nd, 2023 [August 24th, 2021]
- What is testosterone? - November 10th, 2021 [May 23rd, 2021]
- Tribulus Terrestris Review Does It Raise Testosterone or ... - May 23rd, 2021 [May 22nd, 2021]
- Boosting testosterone levels (First of two parts) - May 9th, 2021 [May 8th, 2021]
- How long does it take for Testosterone replacement treatments and therapy to work? - November 27th, 2021 [May 1st, 2021]
- What Is Testosterone AndroGel - November 21st, 2021 [April 28th, 2021]
- Low T - My life was falling apart because I had low testosterone - November 20th, 2021 [April 25th, 2021]
- Deer Antler, HGH and Testosterone: Tim on Scott and BR Radio Show - Video - November 27th, 2021 [April 17th, 2021]
- What is Testosterone? What does Testosterone do? Find on - April 14th, 2021 [April 14th, 2021]
- How Testosterone Affects the Skin of Men - November 28th, 2021 [April 11th, 2021]
- Testosterone, the Power Hormone - November 23rd, 2021 [April 8th, 2021]
- Testosterone Levels and Wall Street - October 28th, 2021 [March 27th, 2021]
- Women can resist testosterone-fuelled political debate - March 13th, 2021 [March 12th, 2021]
- BUSTED: Myths About Testosterone And Its Link To Sexual Desire In Men And Women - November 4th, 2021 [March 11th, 2021]
- Attention Baby Boomers -- Could Testosterone be the Modern Day "Fountain of Youth?" - October 31st, 2022 [March 4th, 2021]
- Declining Testosterone Levels in Men Not Part of Normal Aging - October 18th, 2021 [February 28th, 2021]
- Quick Weight Loss Tips and Diet Recommendations for HRT - October 21st, 2021 [February 28th, 2021]
- Testosterone and Alcohol: Your Health and the Holiday Season - October 18th, 2021 [February 27th, 2021]
- Testosterone builds muscle but has risks - February 25th, 2021 [February 25th, 2021]
- New Study Finds That Testosterone Does Not Increase Cardiovascular Risk - November 21st, 2021 [February 22nd, 2021]
- Evidence Suggests Testosterone Plays Powerful Role in Motivating Revolutionary Change - October 20th, 2021 [February 15th, 2021]
- The Effects of Parenthood Upon Testosterone Levels - November 27th, 2021 [January 9th, 2021]
- Testicular Cancer Survivors are at Risk for Low Testosterone - November 21st, 2021 [January 6th, 2021]
- Amygdala and it's Relationship to Testosterone and Fear - November 5th, 2021 [December 25th, 2020]
- Increased Testosterone DOES NOT Cause Prostate Cancer to Spread - October 19th, 2021 [December 23rd, 2020]
- Testosterone Cypionate and Testosterone Enanthate: The Real Facts - November 16th, 2021 [December 20th, 2020]
- A Surprising Side Effect of Methadone Treatment: Suppressed Testosterone - November 2nd, 2021 [December 18th, 2020]
- The Testosterone Industry Globally is Booming - November 12th, 2021 [December 12th, 2020]
- Five Benefits of Testosterone That You Need to Know - October 22nd, 2021 [December 11th, 2020]
- Testosterone Nasal Gel: A New Form of Testosterone Replacement Therapy - November 23rd, 2021 [December 5th, 2020]
- New Research Proves Testosterone Replacement Therapy is Safe for the Heart - October 31st, 2022 [December 3rd, 2020]
- Skinny Bartender with Low Testosterone Becomes a Ripped Bodybuilder - November 21st, 2021 [December 3rd, 2020]
- Low-T and Your Health - October 17th, 2021 [November 30th, 2020]
- Low Testosterone Levels may Affect Man's Sex Drive and Affect his Intimate Relationships - October 17th, 2021 [November 19th, 2020]
- Is Testosterone the New Drug of Choice on Wall Street? How Traders are Using Male Hormone Booster Shots to Maintain a ... - November 3rd, 2021 [November 12th, 2020]
- Shorter course of ADT for high-risk prostate cancer patients yields improved quality of life - November 11th, 2020 [November 11th, 2020]
- Testosterone Litigation: What You Need To Know - MTMP - Video - October 21st, 2021 [November 9th, 2020]
- Methadone Lowers Testosterone in Men Only - November 9th, 2020 [November 8th, 2020]
- Should middle-aged men consider 'low T' treatment? - November 6th, 2020 [November 5th, 2020]
- Testosterone and Crime: What Can Genes Tell Us About Behavior? - Video - October 25th, 2020 [October 25th, 2020]
- Testosterone shown to help sexually frustrated women - November 28th, 2021 [October 22nd, 2020]
- Testosterone levels seen prior to birth in fetus' fingers, jawline - November 18th, 2021 [October 20th, 2020]
- Tri-Blend Testosterone. Understanding the Benefits of Testosterone Oils - November 9th, 2021 [October 19th, 2020]
- Testosterone levels in older men - November 23rd, 2021 [October 17th, 2020]
- Tlando Testosterone Clinical Trial for Low-T and Fatty Liver Disease - October 29th, 2021 [October 4th, 2020]
- Testosterone Focus in Diabetes Study – Video - September 30th, 2020 [September 30th, 2020]
- Testshock Review All Natural Testosterone Enhancement – Video - September 30th, 2020 [September 30th, 2020]
- Testosterone, Anxiety, and Depression - November 19th, 2021 [September 30th, 2020]
- Average Testosterone Levels Decreasing Over Time Among Younger American Men - November 4th, 2021 [August 21st, 2020]
- Testosterone Creams for Low Testosterone Treatment and Andropause - November 14th, 2021 [August 10th, 2020]
- Testosterone Therapy and Androgen Deficiency Guide - November 29th, 2021 [August 6th, 2020]
- Testosterone's Surprising Link to Men's 'Love Hormone' Oxytocin - October 31st, 2022 [August 5th, 2020]
- Fortesta Brand Testosterone Therapy - November 28th, 2021 [August 3rd, 2020]
- Andropause: Age-Associated Testosterone Decline - October 26th, 2021 [August 1st, 2020]
- How to Build Muscle Quickly by Boosting Testosterone Levels - November 5th, 2021 [July 29th, 2020]
- Testosterone Deficiency Strongly Linked to Heart Attack Risk in New Study - October 16th, 2021 [July 26th, 2020]
- Seven Types of Drugs That Can Inhibit Sex Drive and Libido - October 23rd, 2021 [July 22nd, 2020]
- Testosterone and Geriatric Frailty - October 20th, 2021 [July 21st, 2020]
- Testosterone and Aggression: How T-Levels Impact Human Response to External, Social Threats - November 14th, 2021 [July 12th, 2020]
- High-Dose Testosterone Injections May Be a Viable Palliative Late-Stage Prostate Cancer Treatment - November 10th, 2021 [July 12th, 2020]
- Could Civilization Have Been Formed as a Result of Declining Testosterone Levels in Males? - November 4th, 2021 [July 6th, 2020]
- Testosterone Therapy Allows Man to Have the Body That He Was Meant to Have - November 11th, 2021 [July 5th, 2020]
- Testosterone Injections for Low-T and Andropause - November 5th, 2021 [July 4th, 2020]
- Testosterone Replacement Therapy (TRT) Reduces the Risk of Serious Adverse Health Consequences! - November 9th, 2021 [June 30th, 2020]
- Testosterone not always to blame - Sat, 04 Aug 2012 PST - November 14th, 2021 [June 28th, 2020]
- Five Facts About Testosterone (That Maybe You Didn't Know) - November 20th, 2021 [June 27th, 2020]
- Manhood Washed Away: You Could Unknowingly be Annihilating Your Testosterone - November 28th, 2021 [June 23rd, 2020]
- Testosterone: Should You Take it to Regain Your Libido and Youthful Energy? - November 18th, 2021 [June 22nd, 2020]
- Testosterone Replacement Therapy Boosts Aerobic Capacity - November 19th, 2021 [June 15th, 2020]
- Physiology of Testosterone - November 12th, 2021 [June 9th, 2020]
- The Truth Behind Common Male Sex Myths - November 19th, 2021 [May 26th, 2020]
- Dr. Andre Berger on Testosterone Deficiency in Men - Andropause Symptoms and Treatment By Doctor's Desk Series - January 15th, 2021 [May 21st, 2020]
Word Count: 1204