The administration of testosterone replacement therapy, which is commonly employed to address low levels of testosterone, does not seem to elevate the likelihood of grave cardiovascular complications, as some specialists had apprehended. This conclusion was reached through a study that was published on Friday in The New England Journal of Medicine and presented at ENDO 2023, a yearly gathering of the Endocrine Society that was held in Chicago.
Nearly a decade after the Food and Drug Administration mandated that drug manufacturers investigate the potential cardiovascular consequences of testosterone replacement therapy, the discovery has been made.
For those men who seek to alleviate the symptoms of low testosterone, particularly the loss of sex drive in later years, this may prove to be a much-needed respite. Likewise, physicians who treat these individuals may also find solace in this development.
Dr. Joshua Halpern, a distinguished urologist at Northwestern Medicine in Chicago, expressed his anticipation for the forthcoming trial, which has been eagerly awaited for an extensive period of time.
Halpern, a researcher of testosterone therapy, commented on the recent study, stating that it has offered the most conclusive insight into the correlation between cardiovascular risk and testosterone therapy.
Testosterone replacement therapy is customarily intended for men who have been diagnosed with hypogonadism, a condition characterized by low levels of testosterone in men. The manifestation of symptoms such as fatigue, decreased libido, depressed mood, hair loss, and in certain instances, hot flashes akin to those experienced by women during menopause, may be observed.
According to Dr. Gregory Broderick, a urologist at the Mayo Clinic in Florida who was not involved in the latest research, the manufacturers of topical testosterone products capitalized on the notion that testosterone was akin to the fountain of youth when these products were introduced in the early 2000s.
A deluge of advertisements promoting low T treatment inundated the media, luring men in their middle and later years with the alluring prospect of reclaiming their youthful physiques, boundless vitality, and sexual prowess.
“The distressing symptoms experienced by middle-aged and older men, who are still in the prime of their lives, cannot be overlooked,” stated Dr. Shalender Bhasin, an endocrinologist at Brigham and Women’s Hospital in Boston and a co-author of the recent study. Their influence inspires men who have never sought medical attention to visit a doctor’s office for the first time.
The medication witnessed a significant surge in sales. According to a study in 2013, the utilization of testosterone replacement therapy among men aged 40 and above has surged by over threefold from 0.81% to 2.91% between 2001 and 2011.
According to the study, a significant proportion of those men did not undergo blood tests to ascertain the existence of any genuine medical justification for the treatment. Bhasin pointed out that testosterone levels are not typically assessed during routine blood draws, as the symptoms associated with low testosterone are often perceived as typical indications of aging and do not pose an immediate threat to one’s life. The condition’s true prevalence is challenging to measure, owing to this fact. However, Bhasin approximated it to be within the range of 2% to 4% among middle-aged and older men.
In the year 2013, a study surfaced that raised a significant concern regarding safety. It indicated that males with a history of heart issues who underwent testosterone replacement therapy faced a heightened likelihood of increased risk of heart attack, stroke, and cardiac fatality.
According to experts, the research above and others like it studies lacked the necessary strength to accurately ascertain genuine cardiovascular risks. According to Broderick, who is a former president of the Sexual Medicine Society of North America, the FDA slapped a warning label against testosterone replacement products by affixing a warning label regarding the possibility of cardiovascular issues. In 2015, the agency challenged the manufacturers of testosterone to demonstrate the safety of their drug.
That is precisely where the most recent research findings prove to be invaluable.
Dr. Steven Nissen, the senior author of the paper and chief academic officer of the Heart, Vascular & Thoracic Institute at the Cleveland Clinic, expressed his concern regarding the lack of information on the cardiovascular safety of a therapy that was administered to millions of men. The matter at hand required attention, and we made every effort to attend to it.
The TRAVERSE trial, which aimed to evaluate the long-term vascular events and efficacy response in hypogonadal men, enlisted 5,198 male participants. These individuals had previously undergone two distinct blood tests that confirmed their low testosterone levels and were also experiencing symptoms associated with low T.
In addition, the individuals in question possessed no less than three risk factors for cardiovascular disease, encompassing elevated blood pressure, Type 2 diabetes, anomalous lipid levels, or a smoking background. The study involved individuals ranging from 45 to 80 years of age, with the majority falling within the age bracket of their 60s.
The study participants were divided into two groups. One group was instructed to apply a standard dose of testosterone gel to their arms on a daily basis, while the other group was directed to use a placebo gel.
Following a prolonged period of medical intervention spanning close to twenty-four months, the outcome revealed no discernible variance in the incidence of cardiac arrests, cerebrovascular accidents, or mortality rates attributable to any cardiovascular affliction across the cohorts.
Notwithstanding, the trial revealed that the male subjects who underwent testosterone therapy exhibited a greater propensity for experiencing arrhythmia, renal complications, and thromboembolic events in the lower extremities or pulmonary vasculature, in contrast to their counterparts who received the placebo.
Despite everything, Nissen expressed his relief at the outcome. In my clinic, I have encountered men with severe heart disease who have sought out testosterone prescriptions from other sources. They often ask me with a direct gaze, “Is it safe?” I have been compelled to inform them that we are not privy to the answer.