Testosterone Replacement Therapy Archives

The Association Between Testosterone Treatment and Incident of Cardiovascular Events among Testosterone Deficient U.S. Veterans

by Thomas J. Walsh, MD, MBA, MS | Oct 2024

Thomas J. Walsh, MD, MBA, MS, provides a detailed examination of the relationship between testosterone treatment and the incidence of cardiovascular events among testosterone-deficient U.S. veterans.

In this 19-minute presentation, Dr. Walsh outlines the background of testosterone deficiency, noting ongoing concerns regarding its safety, particularly its potential to increase the risk of heart attacks, strokes, and other heart-related issues.

Drawing on data from a large cohort of U.S. veterans, Dr. Walsh discusses the incidence of cardiovascular events in patients undergoing testosterone therapy compared to those who do not receive such treatment. He discusses the methodology used in the study, including the selection of participants, the duration of follow-up, and the statistical analyses employed to control for confounding variables.

TRAVERSE: Meaning of the Testosterone Safety Trials

by Martin M. Miner, MD | Sep 2024

Martin M. Miner, MD, reviews testosterone safety trials and recent data on the cardiometabolic effects of testosterone, addressing concerns from the FDA about off-label testosterone use among aging men. The TRAVERSE trial, conducted in response to these concerns, examines whether testosterone therapy increases the risk of myocardial infarction or stroke.

In this 12-minute presentation, Dr. Miner provides a comprehensive review of studies from 1940 to 2014, which found minimal evidence suggesting cardiovascular risks associated with testosterone. However, key studies released in 2013-2014 raised concerns about testosterone therapy, indicating a potential increased risk of non-fatal myocardial infarctions. In response, the FDA issued a directive in 2015, leading to the large-scale TRAVERSE trial, a double-blind, placebo-controlled trial that assessed testosterone gel effects over five years.

The TRAVERSE study is notable as the longest randomized, controlled trial on testosterone safety among hypogonadal men to date. Findings indicate that testosterone therapy poses low cardiovascular risk, improves sexual health, and has no significant impact on prostate cancer risk or progression. This suggests that normalized testosterone levels may reduce risks of mortality and adverse cardiovascular events, without elevating prostate cancer concerns.

Testosterone to Improve the Diagnosis and Treatment of Prostate Cancer

by Mohit Khera, MD, MBA, MPH | Nov 2023

Mohit Khera, MD, MBA, MPH, explores how testosterone can help diagnose and treat prostate cancer. He explains that low testosterone is a biomarker for prostate cancer, a predictor of who will progress on active surveillance (AS), and a risk factor for biochemical recurrence after prostatectomy. Further, testosterone therapy can be a treatment for metastatic prostate cancer.

Dr. Khera argues that while testosterone should not be considered a monotherapy, it can augment treatment. He explains PSA has poor sensitivity and addresses biomarker tests that seek to improve sensitivity and specificity. Dr. Khera asserts the ratio of testosterone to PSA has sensitivity of 82 percent and specificity of 62 percent, with lower costs than biomarker tests. He cites data explaining for men with low testosterone, PSA alone may not be accurate. Dr. Khera cites another study on testosterone as a predictor of upstaging and upgrading in low-risk AS patients. It concludes testosterone should be a selection criterion for inclusion of low-risk prostate cancer patients in AS programs.

Dr. Khera explains lower preoperative testosterone levels increase the risk for prostate cancer recurrence. Dr. Khera turns to treatment options, looking at bipolar androgen therapy (BAT) that includes patients with advanced disease receiving high doses of testosterone which results in a 50 percent reduction in both PSA and metastatic disease. Dr. Khera cites a study on BAT for asymptomatic men with castration-resistant prostate cancer; the BAT was well-tolerated and resulted in high response rates.

Dr. Khera cites the TRANSFORMER study comparing BAT vs. enzalutamide. Data show no difference in survival; however, patients who switched from BAT to enzalutamide had the highest survival rates. Dr. Khera concludes that testosterone can improve prostate cancer diagnosis and counseling for patients on biochemical recurrence; it comes with significantly less cost and offers greater quality of life.

Challenging Case Discussion Panel: Men’s Health

by Martin M. Miner, MD | Jul 2023

Martin M. Miner, MD, discusses a challenging case involving testosterone therapy, cardiovascular risk, and prostate cancer. He begins by providing information about a case study patient, highlighting obesity, low testosterone levels, and diminished libido. Dr. Miner then discusses data that find a connection between testosterone therapy and increased cardiovascular risk.

He notes a review of all articles from 1940 to 2014 researching this connection, finding only four studies indicating a connection and uncovering major flaws in their procedures. This leads him to question the link between testosterone therapy and increased cardiovascular risk while also describing the case study patient’s testosterone therapy treatment. Dr. Miner then reviews guidelines from the American Urological Association and the Endocrine Society. He references the case study patient once again, noting the patient’s development of cardiac events and questions whether the patient should return to testosterone therapy.

After reviewing additional data on this topic, Dr. Miner concludes that testosterone therapy has at least neutral effects on cardiovascular risk factors, although additional studies are needed. He transitions the discussion back to the case study patient, noting his new development of prostate cancer and reviewing data on testosterone therapy’s effects on prostate cancer. Dr. Miner opens the discussion up to panelists, who discuss testosterone levels, obesity management, and individualized urologic treatment.

Update on 2018 AUA Testosterone and ED Guidelines

by Mohit Khera, MD, MBA, MPH | Dec 2018

Mohit Khera, MD, MBA, MPH, introduces the 2018 American Urological Association (AUA) guidelines for testosterone therapy and erectile dysfunction. He also describes inconsistencies between these guidelines and various institutions’ statements regarding these clinical areas.

Testosterone Replacement and Focal Therapy

by Mohit Khera, MD, MBA, MPH | Oct 2018

Mohit Khera, MD, MBA, MPH, reviews the literature surrounding the safety of testosterone replacement therapy (TRT) following prostate cancer treatment, including after brachytherapy, EBRT, and radical prostatectomy (RP). He also discusses the concept of bipolar androgen therapy (BAT) and the importance of TRT for erectile preservation post-RP.

Testosterone Therapy, the FDA, and CVD Risk Controversies

by Matt T. Rosenberg, MD | Dec 2017

Dr. Matt T. Rosenberg, MD, argues both sides of the testosterone therapy controversy. He explains how supplementing testosterone in men with testosterone deficiency can be beneficial, but also risky from a cardiovascular standpoint.