Deaths and Cardiovascular Events in Men Receiving Testosterone (original) (raw)
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Testosterone therapy and mortality risk
International journal of impotence research, 2015
Recent data suggest an increased risk of cardiovascular events and mortality in men on testosterone therapy (TT). To date, there are no long-term, prospective studies to determine safety. In such cases, retrospective observational studies can be helpful. We examined our patient database to determine whether TT altered the risk of all-cause mortality in men. We queried our hormone database for all men with a serum testosterone level and then examined charts to determine testosterone status. In all, 509 men had charts available for review. We linked our patient records to the National Death Index to determine mortality. Of the 509 men who met inclusion criteria, 284 were on TT and 225 did not use testosterone. Age (mean 54 years) and follow-up time (mean 10 years) were similar for both groups. In all, 19 men died-10 (4.4%) men not on TT and 9 (3.2%) men on TT. After adjusting for age and year of evaluation, there was no significant difference in the risk of death based on TT (hazard r...
Clinical Endocrinology, 2018
SummaryObjectiveA label change in testosterone (T) products in March 2015 followed a highly publicized FDA advisory committee meeting in September 2014. Changes included a warning of possible increased cardiovascular (CV) risks and restriction of indicated populations to younger men with a limited set of known aetiologies of testosterone deficiency (TD). These changes greatly impacted clinical practice and public perception of T therapy (TTh). Our aim was to review these changes in the light of subsequently published studies.DesignWe identified 23 studies through June 2017, including 12 clinical trials and 11 observational studies. The Testosterone Trials included 790 men aged 65 years and older with TD without known aetiology, assigned to 1‐year T gel or placebo.ResultsDemonstrated benefits of T included sexual activity and desire, physical activity and mood. There were 9 major adverse CV events (MACE) in the T arm and 16 in the placebo arm. No study reported increased MACE with TT...
12-Month Observation of Testosterone Replacement Effectiveness in a General Population of Men
Postgraduate Medicine, 2013
Background: Testosterone decline becomes more prevalent as men age and symptomatic testosterone deficiency is associated with potentially serious comorbidities. Despite limitations, registries can provide an opportunity to accumulate data regarding disease management in a typical patient population, including diagnosis, treatment, and outcomes. Materials and Methods: The Testim Registry in the United States (TRiUS) was a prospective, 12-month, observational cohort registry of men prescribed Testim ® (1% testosterone gel; Auxilium Pharmaceuticals, Inc.) for the first time; patients previously on other forms of testosterone replacement therapy (TRT) were eligible to participate in the study as well. The registry recorded total testosterone (TT) and free testosterone (FT) levels, prostate-specific antigen (PSA), sexual function, mood/depression, and cardiometabolic and anthropometric criteria before and after TRT. Changes over time were analyzed by analysis of variance, and linear regression and Pearson product-moment correlation coefficients were used to examine relationships between variables. Results: At baseline, 849 patients from 72 sites were enrolled, with 743 of 849 started on 5 g gel/day (50 mg testosterone/ day) and 106 of 849 started on 10 g gel/day (100 mg testosterone/day). Mean TT and FT levels increased significantly after 3 months of TRT (TT level, 16.8 ± 9.87 nmol/L [485 ± 284 ng/dL], P , 0.001; FT level, 286.3 ± 224.9 pmol/L [82.5 ± 64.8 pg/mL], P , 0.001) and were maintained at eugonadal levels. Mean PSA levels increased significantly (P = 0.004) from 1.12 ± 1.11 µg/L (1.12 ± 1.11 ng/mL) at baseline to 1.26 ± 1.22 µg/L (1.26 ± 1.22 ng/mL) after 12 months of TRT, although changes were well within guidelines (, 1.4 µg/L/year increase). Significant improvements were seen in sexual function and mood/depression at 3 months and in metabolic parameters at 12 months. Conclusion: Testosterone deficiency symptoms improved with TRT use in men; sexual function and mood/depression improvements were seen before metabolic improvements. Prostate-specific antigen levels increased, although increases were within guideline-determined safety limits.
The benefits and risks of testosterone replacement therapy: a review
Therapeutics and Clinical Risk Management, 2009
Increased longevity and population aging will increase the number of men with late onset hypogonadism. It is a common condition, but often underdiagnosed and undertreated. The indication of testosterone-replacement therapy (TRT) treatment requires the presence of low testosterone level, and symptoms and signs of hypogonadism. Although controversy remains regarding indications for testosterone supplementation in aging men due to lack of large-scale, long-term studies assessing the benefits and risks of testosterone-replacement therapy in men, reports indicate that TRT may produce a wide range of benefits for men with hypogonadism that include improvement in libido and sexual function, bone density, muscle mass, body composition, mood, erythropoiesis, cognition, quality of life and cardiovascular disease. Perhaps the most controversial area is the issue of risk, especially possible stimulation of prostate cancer by testosterone, even though no evidence to support this risk exists. Other possible risks include worsening symptoms of benign prostatic hypertrophy, liver toxicity, hyperviscosity, erythrocytosis, worsening untreated sleep apnea or severe heart failure. Despite this controversy, testosterone supplementation in the United States has increased substantially over the past several years. The physician should discuss with the patient the potential benefits and risks of TRT. The purpose of this review is to discuss what is known and not known regarding the benefits and risks of TRT.
Testosterone Treatment and Mortality in Men with Low Testosterone Levels
The Journal of Clinical Endocrinology & Metabolism, 2012
Context: Low testosterone levels in men have been associated with increased mortality. However, the influence of testosterone treatment on mortality in men with low testosterone levels is not known. Objective: The objective of the study was to examine the association between testosterone treatment and mortality in men with low testosterone levels. Design: This was an observational study of mortality in testosterone-treated compared with untreated men, assessed with time-varying, adjusted Cox proportional hazards regression models. Effect modification by age, diabetes, and coronary heart disease was tested a priori. Setting: The study was conducted with a clinical database that included seven Northwest Veterans Affairs medical centers. Patients: Patients included a cohort of 1031 male veterans, aged older than 40 yr, with low total testosterone [Յ250 ng/dl (8.7 nmol/liter)] and no history of prostate cancer, assessed between January 2001 and December 2002 and followed up through the end of 2005. Main Outcome Measure: Total mortality in testosterone-treated compared with untreated men was measured. Results: Testosterone treatment was initiated in 398 men (39%) during routine clinical care. The mortality in testosterone-treated men was 10.3% compared with 20.7% in untreated men (PϽ0.0001) with a mortality rate of 3.4 deaths per 100 person-years for testosterone-treated men and 5.7 deaths per 100 person-years in men not treated with testosterone. After multivariable adjustment including age, body mass index, testosterone level, medical morbidity, diabetes, and coronary heart disease, testosterone treatment was associated with decreased risk of death (hazard ratio 0.61; 95% confidence interval 0.42-0.88; P ϭ 0.008). No significant effect modification was found by age, diabetes, or coronary heart disease. Conclusions: In an observational cohort of men with low testosterone levels, testosterone treatment was associated with decreased mortality compared with no testosterone treatment. These results should be interpreted cautiously because residual confounding may still be a source of bias. Large, randomized clinical trials are needed to better characterize the health effects of testosterone treatment in older men with low testosterone levels.
Vascular health and risk management, 2016
Long-term testosterone therapy (TTh) in men with hypogonadism has been shown to improve all components of the metabolic syndrome. In this study, we investigated the effects of long-term TTh up to 8 years in hypogonadal men with a history of cardiovascular disease (CVD). In two urological clinics observational registries, we identified 77 hypogonadal men receiving TTh who also had a history of CVD. The effects of TTh on anthropometric and metabolic parameters were investigated for a maximum duration of 8 years. Any occurrence of major adverse cardiovascular events was reported. All men received long-acting injections of testosterone undecanoate at 3-monthly intervals. In 77 hypogonadal men with a history of CVD who received TTh, we observed a significant weight loss and a decrease in waist circumference and body mass index. Mean weight decreased from 114±13 kg to 91±9 kg, change from baseline: -24±1 kg and -20.2%±0.5%. Waist circumference decreased from 112±8 cm to 99±6 cm, change fr...
TESTOSTERONE REPLACEMENT THERAPY: ASSESSMENT OF CARDIOVASCULAR RISKS (Atena Editora)
TESTOSTERONE REPLACEMENT THERAPY: ASSESSMENT OF CARDIOVASCULAR RISKS (Atena Editora), 2024
Objective: Analyze the results of updated 2023 studies to evaluate cardiovascular risks related to testosterone replacement therapy in men, aiming to provide a basis for clinical recommendations. Methodology: Narrative bibliographic review using the PubMed - MEDLINE (Medical Literature Analysis and Retrieval System Online) database. The following search terms were used, along with the Boolean operators "AND" and "OR": Testosterone Replacement Therapy AND Cardiovascular Risk. After applying the inclusion and exclusion criteria, 15 articles were selected for extensive analysis. Review: The results reveal a broad-spectrum view of the topic in question, with the impact of testosterone replacement on the cardiovascular system not being completely evident. In addition to the clinical and physiological benefits of testosterone replacement therapy (TRT), some studies point to a possible increase in cardiovascular adverse events, such as venous thromboembolism, cardiovascular morbidity and mortality, with intramuscular administration being more harmful in this regard, especially in obese men., elderly people, patients with type 2 diabetes, metabolic syndrome and a history of previous cardiovascular disease. Furthermore, there was a tendency to regularly monitor patients on TRT, especially hematocrit levels, to avoid complications such as venous thromboembolism. Final Considerations: The need for clinical and laboratory monitoring of patients is evident, especially in at-risk populations, such as the individualization of therapeutic choice. However, the assessment of the cardiovascular risks associated with TRT in men is still in its infancy due to the limitations of clinical tests, and future studies are needed to better understand the cardiovascular risks of hormone replacement in the target population.
Testosterone and cardiovascular disease - the controversy and the facts
Postgraduate medicine, 2015
Since November 2013, there has been a flurry of articles written in the media touting the risk of cardiovascular (CV) disease in men treated with testosterone, based on two recent reports. Since first synthesized in 1935, testosterone therapy has demonstrated substantial benefits for men with testosterone deficiency (also called hypogonadism). Testosterone has an acceptable safety profile and literature spanning more than 30 years, suggesting a decreased CV risk with low levels of testosterone and benefits associated with testosterone therapy. However, nonmedical media outlets have seized on reports of increased CV risk, and published scathing editorials impugning testosterone therapy as a dangerous and overprescribed treatment. Here, we review these recent studies, and find no scientific basis for assertions of increased CV risk. This article is intended to provide the clinician with the facts needed for an informed discussion with men who suffer from testosterone deficiency and wh...