The Safety of Testosterone Replacement Therapy: New Findings
In a major clinical trial called TRAVERSE, the long-awaited results show that testosterone replacement therapy does not increase the risk of heart attack, stroke, or death among middle-aged and older men with low testosterone levels and high risk of heart disease. The study, which included over 5,000 men aged 45 to 80, found no increased risk of cardiovascular causes, nonfatal heart attack, or stroke in this group. However, there were some side effects observed, including abnormal heart rhythm, acute kidney injury, and blood clots in the lungs, in the group receiving testosterone replacement therapy compared to the placebo group.
No Increased Risk of Prostate Cancer
During the 33-month follow-up period, there was no increased risk of prostate cancer in the men who underwent testosterone replacement therapy. This finding provides some reassurance to patients and healthcare providers who have expressed concerns about the potential link between testosterone therapy and prostate cancer.
The FDA’s Response to Safety Concerns
In 2015, the FDA required the TRAVERSE study in response to concerns and conflicting data regarding the safety of testosterone replacement therapy in men. The study was conducted by a group of five manufacturers of testosterone replacement products, led by AbbVie. The results of this study will play a crucial role in informing future discussions and decisions regarding the use of testosterone therapy.
Presentation at ENDO 2023
The findings of the TRAVERSE study were presented at ENDO 2023, the annual meeting of the Endocrine Society. The data was also published in the prestigious New England Journal of Medicine, further validating the importance and impact of these results. These findings are just the beginning, as more data on various outcomes are expected to be presented at conferences or published in medical journals later this year.
Transforming Risk-Benefit Conversations
One of the study’s co-authors, Dr. Shalendar Bhasin, emphasizes that the TRAVERSE findings will have a significant impact on risk-benefit conversations between patients and healthcare providers regarding testosterone therapy for low testosterone. He notes that while testosterone deficiency may not be life-threatening, it is a major symptomatic condition that affects the quality of life for many middle-aged and older men. These findings will help healthcare providers make more informed treatment decisions and address the complex nature of testosterone therapy.
Exploring the Efficacy of Testosterone Therapy
In the coming months, the TRAVERSE study will provide much better data on the efficacy of testosterone therapy. This encompasses various outcomes such as sexual function, depressive disorder, fractures, anemia, and diabetes. These findings will further contribute to the understanding of testosterone therapy and its potential benefits for patients with low testosterone levels.
Comments from an Endocrinologist
Dr. Bradley D. Anawalt, an endocrinologist, expressed the anticipation among doctors who prescribe testosterone to men for the TRAVERSE study results. He commends the study for revealing that there is no serious risk of strokes and heart attacks associated with testosterone therapy, at least in the early years. However, it is important to note that the safety data from TRAVERSE only applies to men with documented low testosterone levels and does not provide information on the safety of prescribing testosterone therapy to men with normal testosterone concentrations.
Additional Insights on Testosterone Replacement Therapy
Testosterone replacement therapy has been a topic of interest and debate for many years. With the TRAVERSE study shedding new light on its safety and efficacy, it is crucial to have a comprehensive understanding of this treatment option. Here are some additional insights and perspectives to consider:
The Impact of Testosterone Deficiency on Quality of Life
While testosterone deficiency may not be life-threatening, it significantly affects the quality of life for many men. Symptoms such as fatigue, low libido, decreased muscle mass, and mood changes can significantly impact daily functioning and overall well-being. Testosterone replacement therapy can help alleviate these symptoms and improve quality of life for affected individuals.
The Complexities of Treatment Decisions
Decisions regarding testosterone therapy are complex and require careful consideration. Factors such as age, overall health, and individual risk factors should all be taken into account when determining the appropriateness of treatment. The results of the TRAVERSE study provide valuable insights that will assist healthcare providers in making well-informed decisions and having meaningful discussions with their patients.
Monitoring and Managing Side Effects
While the TRAVERSE study found no increased risk of cardiovascular events, it did identify some side effects associated with testosterone replacement therapy. Healthcare providers should closely monitor patients and be vigilant in identifying and managing potential adverse events. Regular follow-up appointments and open communication with patients are essential for ensuring the safety and efficacy of this treatment approach.
Individualized Treatment Approaches
Each patient is unique, and their treatment approach should reflect their specific needs and goals. Testosterone replacement therapy is not a one-size-fits-all solution, and healthcare providers should tailor the treatment to each individual’s circumstances. By considering the patient’s overall health, lifestyle, and preferences, healthcare providers can develop a personalized approach that maximizes the benefits and minimizes the risks of testosterone therapy.
Conclusion: The Safety and Efficacy of Testosterone Replacement Therapy
The TRAVERSE study brings much-needed clarity to the safety concerns surrounding testosterone replacement therapy. With its findings demonstrating no increased risk of heart attack, stroke, or death, the study provides reassurance to patients and healthcare providers alike. As additional data on efficacy outcomes becomes available, a more comprehensive understanding of the benefits and potential side effects of testosterone therapy will emerge.
It is important for individuals considering testosterone replacement therapy to have open and informed discussions with their healthcare providers. By analyzing the patient’s specific circumstances and weighing the potential risks and benefits, healthcare providers can make personalized treatment recommendations that prioritize the patient’s overall well-being.
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June 16, 2023 — Testosterone replacement therapy does not appear to increase the risk of heart attack, stroke, or death from either, among middle-aged and older men with low testosterone levels and high risk of heart disease , the long-awaited results of a major finding in a clinical trial.
Among more than 5,000 men ages 45 to 80, no increased risk of cardiovascular causes, nonfatal heart attack, or stroke was observed.
There was also no increased risk of prostate cancer during the 33-month follow-up period. However, there were increases in a type of abnormal heart rhythm, atrial fibrillation, acute kidney injury, and blood clots in the lungs (pulmonary embolism) in the group that received testosterone replacement therapy compared with those that used a placebo gel.
The FDA required the study to be conducted in 2015 in response to concerns and conflicting data regarding the safety of testosterone replacement therapy in men. It was made by a group of five manufacturers of testosterone replacement products, led by AbbVie.
The findings were to be presented on Saturday at ENDO 2023: the annual meeting of the Endocrine Society. The data was also published in the New England Journal of Medicine.
These results are the first to be reported from the study, called TRAVERSE. Other findings on so-called “efficacy” outcomes, including sexual function, depressive disorder, fractures, anemia, and diabetes, are expected to be presented at a conference and/or published in a medical journal later this year.
Taken together, the TRAVERSE findings are expected to transform risk-benefit conversations with patients about the use of testosterone therapy for low testosterone, said study co-author Shalendar Bhasin, MD.
“To our knowledge, testosterone deficiency does not kill people, but it is actually a major symptomatic condition that affects quality of life. Many middle-aged and older men seek help for these symptoms, so it is an important condition and treatment decisions are complicated,” said Bhasin, director of the Men’s Health Research Program: Aging and Metabolism at Brigham Hospital. and Women’s, in Boston. .
“We will have much better data on efficacy in the coming months,” he added.
‘Real data on something we’ve been prescribing for decades’
When asked for comment, endocrinologist Bradley D. Anawalt MD said that “the community of doctors who prescribe testosterone to men was looking forward with great anticipation” to the TRAVERSE results.
“Until now, we had to say well, there could be a risk of strokes and heart attacks. This study says a lot that there is not a serious risk, at least in the early years, of testosterone therapy,” said Anwalt, a professor of medicine at the University of Washington in Seattle.
However, Anawalt emphasized that the TRAVERSE safety data applies only to men with documented low testosterone levels.
“It does not give carte blanche to prescribe men with normal testosterone concentrations. It doesn’t tell us about the safety of that,” she said.
https://www.webmd.com/men/news/20230616/testosterone-safe-for-most-older-men?src=RSS_PUBLIC
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