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Review of health risks of low testosterone and testosterone administration.

ABSTRACT: Hypogonadism is prevalent in older men and testosterone replacement therapy (TRT) for older hypogonadal men is a promising therapy. However, a number of important clinical concerns over TRT safety remain unsolved due to a lack of large-scale randomized clinical trials directly comparing the health risks of untreated hypogonadism vs long-term use of TRT. Meta-analyses of clinical trials of TRT as of 2010 have identified three major adverse events resulting from TRT: polycythemia, an increase in prostate-related events, and a slight reduction in serum high-density lipoprotein cholesterol. There are other purported health risks but their incidence can be neither confirmed nor denied based on the small number of subjects that have been studied to date. Furthermore, subsequent literature is equivocal with regard to the safety and utility of TRT and this topic has been subject to contentious debate. Since January 2014, the United States Food and Drug Administration has released two official announcements regarding the safety of TRT and clinical monitoring the risks in TRT users. Additionally, the health risks related to the clinical presentation of low or declining testosterone levels not been resolved in the current literature. Because TRT is prescribed in the context of putative risks resulting from reduced testosterone levels, we reviewed the epidemiology and reported risks of low testosterone levels. We also highlight the current information about TRT utilization, the risks most often claimed to be associated with TRT, and current or emerging alternatives to TRT.

SUBMITTER: Jia H

PROVIDER: S-EPMC4391003 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Review of health risks of low testosterone and testosterone administration.

Jia Huanguang H Sullivan Charles T CT McCoy Sean C SC Yarrow Joshua F JF Morrow Matthew M Borst Stephen E SE

World journal of clinical cases 20150401 4

Hypogonadism is prevalent in older men and testosterone replacement therapy (TRT) for older hypogonadal men is a promising therapy. However, a number of important clinical concerns over TRT safety remain unsolved due to a lack of large-scale randomized clinical trials directly comparing the health risks of untreated hypogonadism vs long-term use of TRT. Meta-analyses of clinical trials of TRT as of 2010 have identified three major adverse events resulting from TRT: polycythemia, an increase in p ...[more]

PMID: 25879005

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Project description:BACKGROUND:Inappropriate testosterone use and variations in testosterone prescribing patterns exist in the Veterans Health Administration (VHA) despite the presence of clinical guidelines. OBJECTIVE:We examined system and clinician factors that contribute to patterns of potentially inappropriate testosterone prescribing in VHA. DESIGN:Qualitative study using a positive deviance approach to understand practice variation in high- and low-testosterone prescribing sites. PARTICIPANTS:Twenty-two interview participants included primary care and specialty clinicians, key opinion leaders, and pharmacists at 3 high- and 3 low-testosterone prescribing sites. APPROACH:Semi-structured phone interviews were conducted, transcribed, and coded using a priori theoretical constructs and emergent themes. Case studies were developed for each site and a cross-case matrix was created to evaluate variation across high- and low-prescribing sites. KEY RESULTS:We identified four system-level domains related to variation in testosterone prescribing: organizational structures and processes specific to testosterone prescribing, availability of local guidance on testosterone prescribing, well-defined dissemination process for local testosterone polices, and engagement in best practices related to testosterone prescribing. Two clinician-level domains were also identified, specifically, structured initial testosterone prescribing process and specified follow-up testosterone prescribing process. High- and low-testosterone prescribing sites systematically varied in the four system-level domains, while the clinician-level domains looked similar across all sites. The third high-prescribing site was unusual in that it exhibited the four domains similar to the 3 low-prescribing sites at the time of our visit. This site had greatly reduced its prescribing of testosterone in the interim. CONCLUSIONS:Findings suggest that local organizational factors play an important role in influencing prescribing. Sites have the potential to transform their utilization patterns by providing access to specialty care expertise, an electronic health record-based system to facilitate guideline-concordant prescribing, well-defined dissemination processes for information, guidance from multiple sources, and clarity regarding best practices for prescribing.

Project description:Importance:Androgen deficiency is common among male opioid users, and opioid use has emerged as a common antecedent of testosterone treatment. The long-term health outcomes associated with testosterone therapy remain unknown, however. Objective:To compare health outcomes between long-term opioid users with testosterone deficiency who filled testosterone prescriptions and those with the same condition but who did not receive testosterone treatment. Design, Setting, and Participants:This cohort study focused on men in the care of the Veterans Health Administration (VHA) facilities throughout the United States from October 1, 2008, to September 30, 2014. It included male veterans who were long-term opioid users, had low testosterone levels (<300 ng/dL), and received either a testosterone prescription or any other prescription. It excluded male patients with HIV infection, gender dysphoria, or prostate cancer and those who received testosterone in fiscal year 2008. Data were analyzed from April 1, 2017, to April 30, 2019. Exposure:Prescription for testosterone. Main Outcomes and Measures:All-cause mortality and incidence of major adverse cardiovascular events (MACE), vertebral or femoral fractures, and anemia during the 6-year follow-up through September 30, 2015. Results:After exclusions, 21?272 long-term opioid users (mean [SD] age, 53 [10] years; n?=?16 689 [78.5%] white) with low total or free testosterone levels were included for analysis, of whom 14?121 (66.4%) received testosterone and 7151 (33.6%) did not. At baseline, compared with opioid users who did not receive testosterone, long-term opioid users who received testosterone treatment were more likely to have obesity (43.7% vs 49.0%; P?<?.001), hyperlipidemia (43.0% vs 48.8%; P?<?.001), and hypertension (53.9% vs 55.2%; P?=?.07) but had lower prevalence of coronary artery disease (15.9% vs 12.9%; P?<?.001) and stroke (2.4% vs 1.3%; P?<?.001). After adjusting for covariates, opioid users who received testosterone had significantly lower all-cause mortality (hazard ratio [HR]?=?0.51; 95% CI, 0.42-0.61) and lower incidence of MACE (HR?=?0.58; 95% CI, 0.51-0.67), femoral or hip fractures (HR?=?0.68; 95% CI, 0.48-0.96), and anemia (HR?=?0.73; 95% CI, 0.68-0.79) during the follow-up period of up to 6 years, compared with their counterparts without a testosterone prescription. In covariate-adjusted models, men who received opioids plus testosterone were more likely to have resolved anemia compared with those who received opioids only during the 6-year follow-up (HR?=?1.16; 95% CI, 1.02-1.31). Similar results were obtained in propensity score-matched models and when analyses were restricted to opioid users with noncancer pain or those who did not receive glucocorticoids. Conclusions and Relevance:This study found that, in the VHA system, male long-term opioid users with testosterone deficiency who were treated with opioid and testosterone medications had significantly lower all-cause mortality and significantly lower incidence of MACE, femoral or hip fractures, and anemia after a multiyear follow-up. These results warrant confirmation through a randomized clinical trial to ascertain the efficacy of testosterone in improving health outcomes for opioid users with androgen deficiency.

Project description:Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied.Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group.A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load.In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy. (ClinicalTrials.gov number, NCT00240981.)

Project description:BackgroundUsing the most effective methods and techniques for communicating risk to the public is critical. Understanding the impact that different types of risk communication have played in real and perceived public health risks can provide information about how messages, policies and programs can and should be communicated in order to be most effective. The purpose of this systematic review is to identify the effectiveness of communication strategies and factors that impact communication uptake related to environmental health risks.MethodsA systematic review of English articles using multiple databases with appropriate search terms. Data sources also included grey literature. Key organization websites and key journals were hand searched for relevant articles. Consultation with experts took place to locate any additional references.Articles had to meet relevance criteria for study design [randomized controlled trials, clinical controlled trials, cohort analytic, cohort, any pre-post, interrupted time series, mixed methods or any qualitative studies), participants (those in community-living, non-clinical populations), interventions (including, but not limited to, any community-based methods or tools such as Internet, telephone, media-based interventions or any combination thereof), and outcomes (reported measurable outcomes such as awareness, knowledge or attitudinal or behavioural change). Articles were assessed for quality and data was extracted using standardized tools by two independent reviewers. Articles were given an overall assessment of strong, moderate or weak quality.ResultsThere were no strong or moderate studies. Meta-analysis was not appropriate to the data. Data for 24 articles were analyzed and reported in a narrative format. The findings suggest that a multi-media approach is more effective than any single media approach. Similarly, printed material that offers a combination of information types (i.e., text and diagrams) is a more effective than just a single type, such as all text. Findings also suggest that factors influencing response to risk communications are impacted by personal risk perception, previous personal experience with risk, sources of information and trust in those sources.ConclusionsNo single method of message delivery is best. Risk communication strategies that incorporate the needs of the target audience(s) with a multi-faceted delivery method are most effective at reaching the audience.

Project description:IntroductionThe objective of this study is review the evidence on the health risks associated with smoking kretek cigarettes compared with not smoking or smoking regular cigarettes.MethodsWe conducted a systematic literature search in five electronic databases: EMBASE (Ovid), ASSIA, PubMed and Scopus. Since kretek use is largely restricted to Indonesia, we identified additional studies using an online search for grey literature and studies in Indonesian journals and the National Library of Indonesia. We included relevant search terms in English ("kretek" and "clove cigarettes") and Bahasa ("rokok" and "merokok"). We selected studies which compared any health outcome between smokers of kretek cigarettes and non-smokers or smokers of regular cigarettes. We included studies in any smokers compared to non-smokers in Indonesia, since most Indonesian smokers use kretek, but analysed these separately. Study data were extracted by a single reviewer and checked by two reviewers. Methodological quality was assessed using the Newcastle-Ottawa scale.ResultsWe identified 32 studies, all from Indonesia. There were 31 cross-sectional studies and one case control study. This systematic review identified a relatively limited number of studies, and most of these were of poor quality as assessed by the Newcastle Ottawa score. They were generally cross-sectional, small and lacking justification for sample size, had high potential for selection bias because of lack of data on non-respondents or those lost to follow up, and missing information about the statistical analysis. Fourteen studies looked specifically at kretek exposure and eighteen looked at any type of cigarette exposure but were conducted in Indonesia are therefore likely to predominantly reflect kretek exposure. Kretek were found to be associated with oral cancer, cardiovascular disease, chronic health disease, myocardial infarction, asthma, and oral diseases.ConclusionsAlthough existing studies are of poor quality, kretek are likely to be at least as harmful as regular cigarettes.

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Review of health risks of low testosterone and testosterone administration.

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Review of health risks of low testosterone and testosterone administration.

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