D
MESO-Rx
Anabolic Steroids
Androgen Replacement
- Thread starter Michael Scally MD
- Start date
So transdermal is better to help keep the blood levels more manageable then?
Is Testosterone Replacement Therapy in Older Men Effective and Safe?
The number of older adults over 65 years of age is expected to increase to almost 100 million in the US by 2050, more than double the current figure of 46 million. Advanced age is associated with increased frailty among older Americans and often leads to increased disability, hospitalization, institutionalization, and, eventually, mortality.
In search of means to improve age-related risks for adverse health outcomes, the question of restoring diminishing sex hormones has gathered much interest and has led to the practice of sex hormone replacement therapies in older men.
Recent data suggest that androgen prescription rates in the US for men older than 60 years of age quadrupled from the years 2001 to 2011. While prescription sales of testosterone have increased from $150 million in 2000 to $1.8 billion in 2011, a significant portion of men prescribed testosterone replacement therapy did not meet the laboratory criteria for hypogonadism.
While some clinical trials reported an association between testosterone insufficiency in older men and increased risk of death, the exact effects and consequences of testosterone replacement therapy, specifically in older men, remain unclear. This review is aimed at discussing the possible benefits and complications of testosterone replacement therapy in older men over 60 years of age.
Yabluchanskiy A, Tsitouras PD. Is Testosterone Replacement Therapy in Older Men Effective and Safe? Drugs & Aging 2019. Is Testosterone Replacement Therapy in Older Men Effective and Safe?
The number of older adults over 65 years of age is expected to increase to almost 100 million in the US by 2050, more than double the current figure of 46 million. Advanced age is associated with increased frailty among older Americans and often leads to increased disability, hospitalization, institutionalization, and, eventually, mortality.
In search of means to improve age-related risks for adverse health outcomes, the question of restoring diminishing sex hormones has gathered much interest and has led to the practice of sex hormone replacement therapies in older men.
Recent data suggest that androgen prescription rates in the US for men older than 60 years of age quadrupled from the years 2001 to 2011. While prescription sales of testosterone have increased from $150 million in 2000 to $1.8 billion in 2011, a significant portion of men prescribed testosterone replacement therapy did not meet the laboratory criteria for hypogonadism.
While some clinical trials reported an association between testosterone insufficiency in older men and increased risk of death, the exact effects and consequences of testosterone replacement therapy, specifically in older men, remain unclear. This review is aimed at discussing the possible benefits and complications of testosterone replacement therapy in older men over 60 years of age.
Yabluchanskiy A, Tsitouras PD. Is Testosterone Replacement Therapy in Older Men Effective and Safe? Drugs & Aging 2019. Is Testosterone Replacement Therapy in Older Men Effective and Safe?
[OA] Late-Onset Hypogonadism (LOH): A Concept Comes of Age
The term Late-onset hypogonadism (LOH) was coined in 2002 and defined as a disease entity in the ISA, ISSAM, EAU, EAA and ASA endorsed Recommendations for Investigation, Treatment and Monitoring of LOH (2005 and 2008) as "a clinical and biochemical syndrome associated with advancing age, characterized by symptoms and a deficiency in serum testosterone (T)".
LOH was classified as a combined primary and secondary hypogonadism since the endocrine capacity of the testes as well as the pituitary are impaired. Symptoms of LOH include loss of libido, erectile dysfunction, loss of muscle mass, increased body fat, anemia, osteoporosis, depressed mood, decreased vitality, sweating and hot flushes.
Since these symptoms may also have origins other than LOH, exclusion of other disease entities and subnormal serum T levels are considered prerequisites for the diagnosis and possible treatment of LOH. However, during following years these guidelines were often neglected and, especially in the USA, indiscriminate prescribing of T was widely practised so that the US FDA warned against such irresponsible behavior.
In Europe T prescribing remained largely restricted to LOH as defined above. Nevertheless, a discussion started whether LOH really exists or is only a consequence of age-related comorbidities. Numerous studies have helped to clarify the situation, in particular, the European Male Aging Study (EMAS) and the US-initiated 7 T trials.
Consequently the newest US Endocrine Society Practice Guideline on T treatment (2018) includes advanced age as a cause of organic hypogonadism and recommends that "in men >65 years who have symptoms or conditions suggestive of T deficiency ... and consistently and unequivocally low morning T concentrations we suggest that clinicians offer T therapy on an individualised basis after explicit discussion of the potential risks and benefits." Thus the concept of LOH as conceived two decades ago has weathered criticism and survived the times.
Nieschlag E. Late-onset hypogonadism (LOH): a concept comes of age. Andrology 2019. https://onlinelibrary.wiley.com/doi/abs/10.1111/andr.12719
The term Late-onset hypogonadism (LOH) was coined in 2002 and defined as a disease entity in the ISA, ISSAM, EAU, EAA and ASA endorsed Recommendations for Investigation, Treatment and Monitoring of LOH (2005 and 2008) as "a clinical and biochemical syndrome associated with advancing age, characterized by symptoms and a deficiency in serum testosterone (T)".
LOH was classified as a combined primary and secondary hypogonadism since the endocrine capacity of the testes as well as the pituitary are impaired. Symptoms of LOH include loss of libido, erectile dysfunction, loss of muscle mass, increased body fat, anemia, osteoporosis, depressed mood, decreased vitality, sweating and hot flushes.
Since these symptoms may also have origins other than LOH, exclusion of other disease entities and subnormal serum T levels are considered prerequisites for the diagnosis and possible treatment of LOH. However, during following years these guidelines were often neglected and, especially in the USA, indiscriminate prescribing of T was widely practised so that the US FDA warned against such irresponsible behavior.
In Europe T prescribing remained largely restricted to LOH as defined above. Nevertheless, a discussion started whether LOH really exists or is only a consequence of age-related comorbidities. Numerous studies have helped to clarify the situation, in particular, the European Male Aging Study (EMAS) and the US-initiated 7 T trials.
Consequently the newest US Endocrine Society Practice Guideline on T treatment (2018) includes advanced age as a cause of organic hypogonadism and recommends that "in men >65 years who have symptoms or conditions suggestive of T deficiency ... and consistently and unequivocally low morning T concentrations we suggest that clinicians offer T therapy on an individualised basis after explicit discussion of the potential risks and benefits." Thus the concept of LOH as conceived two decades ago has weathered criticism and survived the times.
Nieschlag E. Late-onset hypogonadism (LOH): a concept comes of age. Andrology 2019. https://onlinelibrary.wiley.com/doi/abs/10.1111/andr.12719
[OA] Factors Associated with The Initiation of Testosterone Replacement Therapy in Men From The 45 And Up Study
BACKGROUND AND OBJECTIVES: There have been large increases in testosterone prescribing since 2000. The aim of this study was to identify factors associated with testosterone replacement therapy (TRT) initiation in men.
METHODS: Data were from the 45 and Up Study, an ongoing cohort study involving 266,942 participants from New South Wales aged >/=45 years. Baseline data (2006-09) were linked to administrative data on government-subsidised prescriptions and medical services.
RESULTS: The study included 105,429 men. In two years following baseline, 2.9 per 1000 men (95% confidence interval: 2.6, 3.2) had initiated TRT. Men with self-rated poor health, those treated for osteoporosis; anxiety, depression or high blood cholesterol, and those who lived in major cities or were aged 55-74 years had greater odds of TRT initiation. In the six months before TRT initiation, 41% of men had a hormone test record.
DISCUSSION: The high rate of TRT initiation and low rate of recommended investigations suggest TRT may have been prescribed outside recommended indications.
Cheng Y, Bateson D, Concepcion K, et al. Factors associated with the initiation of testosterone replacement therapy in men from the 45 and Up Study. Australian journal of general practice 2018;47:698-704. RACGP - Initiation of testosterone replacement therapy
BACKGROUND AND OBJECTIVES: There have been large increases in testosterone prescribing since 2000. The aim of this study was to identify factors associated with testosterone replacement therapy (TRT) initiation in men.
METHODS: Data were from the 45 and Up Study, an ongoing cohort study involving 266,942 participants from New South Wales aged >/=45 years. Baseline data (2006-09) were linked to administrative data on government-subsidised prescriptions and medical services.
RESULTS: The study included 105,429 men. In two years following baseline, 2.9 per 1000 men (95% confidence interval: 2.6, 3.2) had initiated TRT. Men with self-rated poor health, those treated for osteoporosis; anxiety, depression or high blood cholesterol, and those who lived in major cities or were aged 55-74 years had greater odds of TRT initiation. In the six months before TRT initiation, 41% of men had a hormone test record.
DISCUSSION: The high rate of TRT initiation and low rate of recommended investigations suggest TRT may have been prescribed outside recommended indications.
Cheng Y, Bateson D, Concepcion K, et al. Factors associated with the initiation of testosterone replacement therapy in men from the 45 and Up Study. Australian journal of general practice 2018;47:698-704. RACGP - Initiation of testosterone replacement therapy
A Critique of the AUA Guidelines on Testosterone Deficiency
The publication of the first American Urological Association (AUA) guidelines regarding the evaluation and management of testosterone deficiency (TD) in 2018 (“Guidelines”) was a landmark event, serving to recognize the importance of this condition for US urologists.
Urologists play an outsized role in the treatment of men with TD because presenting symptoms are usually sexual. Urologists also have nearly 80 years of experience observing the effects of androgen deprivation.
The creation of clinical guidelines is a rigorous process intended to distill the best available evidence into a set of recommendations to guide health care providers in management of a condition. We congratulate the AUA Guidelines Committee for producing an excellent, useful document for the evaluation and management of men with TD.
In particular, the Guidelines have advanced the field by acknowledging the utility of testosterone (T) therapy (TTh) in selected men with prostate cancer.
As experienced clinicians and investigators in the field, we welcomed the Journal’s invitation to provide a critique of the Guidelines. Below, we comment on a number of topics where our perspective differs from that of the Guideline authors.
These Guidelines, as do all others, emphasize reliance on evidence to support recommendations; yet, as Powers noted, “. guidelines are not just summaries of the evidence. They are also interpretations of that evidence by guideline authors who bring to the process their own conscious and unconscious biases.” Further, many aspects of clinical decision-making have never been tested experimentally.
Together, these limitations mean that many recommendations represent opinions rather than clear interpretations of high-quality data. This is a general feature of all guidelines. A study of cardiology guidelines found that of more than 7,000 recommendations a median of only 11% were based on data from randomized controlled trials, and 48% were based on expert opinion.
The challenge for new guidelines is to incorporate solid existing practices with the best research evidence. It is no wonder that numerous studies across many fields show poor compliance with guidelines.
…
Our greatest area of disagreement is with the overly conservative diagnostic threshold of 300 ng/dL. This threshold is not followed by most experienced clinicians, and its application will result in many men suffering from classic symptoms of TD being denied treatment. We hope this threshold value will be liberalized in future Guidelines. We also believe that free testosterone plays an important role in diagnosing TD, and we encourage ordering this test as well as SHBG to evaluate the man presenting with symptoms suggestive of TD.
Morgentaler A, Traish AM, Khera M. A Critique of the AUA Guidelines on Testosterone Deficiency. The Journal of Sexual Medicine. Redirecting
The publication of the first American Urological Association (AUA) guidelines regarding the evaluation and management of testosterone deficiency (TD) in 2018 (“Guidelines”) was a landmark event, serving to recognize the importance of this condition for US urologists.
Urologists play an outsized role in the treatment of men with TD because presenting symptoms are usually sexual. Urologists also have nearly 80 years of experience observing the effects of androgen deprivation.
The creation of clinical guidelines is a rigorous process intended to distill the best available evidence into a set of recommendations to guide health care providers in management of a condition. We congratulate the AUA Guidelines Committee for producing an excellent, useful document for the evaluation and management of men with TD.
In particular, the Guidelines have advanced the field by acknowledging the utility of testosterone (T) therapy (TTh) in selected men with prostate cancer.
As experienced clinicians and investigators in the field, we welcomed the Journal’s invitation to provide a critique of the Guidelines. Below, we comment on a number of topics where our perspective differs from that of the Guideline authors.
These Guidelines, as do all others, emphasize reliance on evidence to support recommendations; yet, as Powers noted, “. guidelines are not just summaries of the evidence. They are also interpretations of that evidence by guideline authors who bring to the process their own conscious and unconscious biases.” Further, many aspects of clinical decision-making have never been tested experimentally.
Together, these limitations mean that many recommendations represent opinions rather than clear interpretations of high-quality data. This is a general feature of all guidelines. A study of cardiology guidelines found that of more than 7,000 recommendations a median of only 11% were based on data from randomized controlled trials, and 48% were based on expert opinion.
The challenge for new guidelines is to incorporate solid existing practices with the best research evidence. It is no wonder that numerous studies across many fields show poor compliance with guidelines.
…
Our greatest area of disagreement is with the overly conservative diagnostic threshold of 300 ng/dL. This threshold is not followed by most experienced clinicians, and its application will result in many men suffering from classic symptoms of TD being denied treatment. We hope this threshold value will be liberalized in future Guidelines. We also believe that free testosterone plays an important role in diagnosing TD, and we encourage ordering this test as well as SHBG to evaluate the man presenting with symptoms suggestive of TD.
Morgentaler A, Traish AM, Khera M. A Critique of the AUA Guidelines on Testosterone Deficiency. The Journal of Sexual Medicine. Redirecting
[OA] European Academy of Andrology (EAA) Guidelines on Investigation, Treatment and Monitoring of Functional Hypogonadism
Background: Evidence regarding functional hypogonadism, previously referred to as "late-onset" hypogonadism (LOH), has increased substantially during the last 10 year.
Objective: To update the European Academy of Andrology (EAA) guidelines on functional hypogonadism.
Methods: Expert group of Academicians appointed by the EAA generated a series of consensus recommendations according to the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system.
Results: The diagnosis of functional hypogonadism should be based on both the presence of clinical symptoms supported by repeatedly low morning fasting serum total testosterone (T) measured with a well-validated assay, after exclusion of organic causes of hypogonadism.
Lifestyle changes and weight reduction should be the first approach in all overweight and obese men. Whenever possible, withdrawal/modification of drugs potentially interfering with T production should be advised. Testosterone Replacement Therapy (TRT) is contra-indicated in men with untreated prostate or breast cancer, as well as severe heart failure.
Severe low urinary tract symptoms and haematocrit >48-50% represent relative contraindications for TRT. Prostate specific antigen (PSA) and digital rectal examination (DRE) of the prostate should be undertaken in men>40 years of age before initiating TRT to exclude occult prostate cancer.
Transdermal T should be preferred for initiation of TRT whereas gonadotrophin therapy is only recommended when fertility is desired in men with secondary hypogonadism. TRT is able to improve sexual function in hypogonadal men. Other potential positive outcomes of TRT remain uncertain and controversial.
Conclusion: TRT can reliably improve global sexual function in men with hypogonadism in the short term. Long-term clinical benefits, and safety of TRT in functional hypogonadism, remain to be fully documented. Clinicians should therefore explicitly discuss the uncertainties and benefits of TRT and engage them in shared management decision-making.
Corona G, Goulis DG, Huhtaniemi I, et al. European Academy of Andrology (EAA) guidelines on investigation, treatment and monitoring of functional hypogonadism in males [published online ahead of print, 2020 Feb 5]. Andrology. 2020;10.1111/andr.12770. Error - Cookies Turned Off
Background: Evidence regarding functional hypogonadism, previously referred to as "late-onset" hypogonadism (LOH), has increased substantially during the last 10 year.
Objective: To update the European Academy of Andrology (EAA) guidelines on functional hypogonadism.
Methods: Expert group of Academicians appointed by the EAA generated a series of consensus recommendations according to the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system.
Results: The diagnosis of functional hypogonadism should be based on both the presence of clinical symptoms supported by repeatedly low morning fasting serum total testosterone (T) measured with a well-validated assay, after exclusion of organic causes of hypogonadism.
Lifestyle changes and weight reduction should be the first approach in all overweight and obese men. Whenever possible, withdrawal/modification of drugs potentially interfering with T production should be advised. Testosterone Replacement Therapy (TRT) is contra-indicated in men with untreated prostate or breast cancer, as well as severe heart failure.
Severe low urinary tract symptoms and haematocrit >48-50% represent relative contraindications for TRT. Prostate specific antigen (PSA) and digital rectal examination (DRE) of the prostate should be undertaken in men>40 years of age before initiating TRT to exclude occult prostate cancer.
Transdermal T should be preferred for initiation of TRT whereas gonadotrophin therapy is only recommended when fertility is desired in men with secondary hypogonadism. TRT is able to improve sexual function in hypogonadal men. Other potential positive outcomes of TRT remain uncertain and controversial.
Conclusion: TRT can reliably improve global sexual function in men with hypogonadism in the short term. Long-term clinical benefits, and safety of TRT in functional hypogonadism, remain to be fully documented. Clinicians should therefore explicitly discuss the uncertainties and benefits of TRT and engage them in shared management decision-making.
Corona G, Goulis DG, Huhtaniemi I, et al. European Academy of Andrology (EAA) guidelines on investigation, treatment and monitoring of functional hypogonadism in males [published online ahead of print, 2020 Feb 5]. Andrology. 2020;10.1111/andr.12770. Error - Cookies Turned Off
Old
New Member
Yes, obesity needs to be addressed, however TRT can help. The question would be, does weight loss restore proper T levels?
If it is a question of lipid generated E2, then an AI might be useful. But expecting someone to loose weight with hypogonadism can be problematic.
Why would a patient be prescribed an unneeded drug? Oh, yea, now I remember - medical mismanagement is one of the top reasons for death.
No, No, and No. Outdated info.
Erythrocytosis of itself in not dangerous.
Note: can't comment on the extremes AAS users might find themselves in.
Treatment of Estrogen Levels in The Management of Hypogonadism: An Anonymous Survey of ISSM Members
Objective - To assess the variability in management of estrogen levels in men treated with testosterone therapy (TTh). With the significant increase in the last two decades in the treatment of hypogonadism and the use of TTh, detailed guidelines for the management of estrogen levels are necessary. (1)
Materials and Methods - An anonymous survey was electronically distributed to the membership of the International Society for Sexual Medicine including questions on demographics, symptoms, and their approach to management of estrogen in patients on TTh. Chi-square test was used to determine associations.
Results - The response rate was 22.5% (489/2168). 62.4% indicated that they check serum estrogen at initial evaluation, but only 54.7% monitor levels in patients on TTh (p=0.02). Fellowship-trained and North American respondents were more likely to monitor patients(p<0.05).
69.4%, 47.7%, and 14.4% of respondents prescribe anti-estrogenic medications in symptomatic patients with elevated estrogen levels, for asymptomatic elevated estrogen levels, and prophylactically respectively.
Academic respondents were more likely to prescribe an anti-estrogen medication to symptomatic patients and prophylactically(p<0.05). Anastrozole was the most common medication prescribed for symptomatic hyperestrogenemia (62.3%), but starting doses varied significantly, from 1mg weekly to 1mg daily.
Conclusions - Approximately 50% of practitioners treating men with TTh monitor estrogen levels. Symptoms play a role in prescribing patterns and significant variability in aromatase inhibitors regimens exists. Increased monitoring of estrogen levels in men on TTh will facilitate an understanding of the symptoms, effects of high and low estrogen levels, and aid in standardization of research and therapy.
Butaney M, Thirumavalavan N, Balasubramanian A, et al. Treatment of estrogen levels in the management of hypogonadism: An anonymous survey of ISSM members. Urology. Redirecting
Objective - To assess the variability in management of estrogen levels in men treated with testosterone therapy (TTh). With the significant increase in the last two decades in the treatment of hypogonadism and the use of TTh, detailed guidelines for the management of estrogen levels are necessary. (1)
Materials and Methods - An anonymous survey was electronically distributed to the membership of the International Society for Sexual Medicine including questions on demographics, symptoms, and their approach to management of estrogen in patients on TTh. Chi-square test was used to determine associations.
Results - The response rate was 22.5% (489/2168). 62.4% indicated that they check serum estrogen at initial evaluation, but only 54.7% monitor levels in patients on TTh (p=0.02). Fellowship-trained and North American respondents were more likely to monitor patients(p<0.05).
69.4%, 47.7%, and 14.4% of respondents prescribe anti-estrogenic medications in symptomatic patients with elevated estrogen levels, for asymptomatic elevated estrogen levels, and prophylactically respectively.
Academic respondents were more likely to prescribe an anti-estrogen medication to symptomatic patients and prophylactically(p<0.05). Anastrozole was the most common medication prescribed for symptomatic hyperestrogenemia (62.3%), but starting doses varied significantly, from 1mg weekly to 1mg daily.
Conclusions - Approximately 50% of practitioners treating men with TTh monitor estrogen levels. Symptoms play a role in prescribing patterns and significant variability in aromatase inhibitors regimens exists. Increased monitoring of estrogen levels in men on TTh will facilitate an understanding of the symptoms, effects of high and low estrogen levels, and aid in standardization of research and therapy.
Butaney M, Thirumavalavan N, Balasubramanian A, et al. Treatment of estrogen levels in the management of hypogonadism: An anonymous survey of ISSM members. Urology. Redirecting
[OA] (D)evolving attitudes toward late onset hypogonadism
Although chemotherapy is no complete substitute for psychotherapy in the treatment of impotence of the male patient, nevertheless, in cases where psychologic and/or somatic failure plays a role as etiologic agent then indeed chemotherapy is indicated.
—T. Jakobovits
Our Fertility and Sterility no longer focuses on issues related to the clinical condition variably referred to as andropause, male menopause, or late-onset hypogonadism (LoH). In fact, the Food and Drug Administration, as evidenced by their 2015 Safety Advisory for testosterone supplements, argues that this condition may not even exist.
While this controversy rages on, Dr. Thomas Jakobovits, working in Boston, MA, provides us with evidence for an impressive treatment response to empiric hormonal therapy among such men. Although this article is thin on methodology and scientific rationale, it is a precious double-blind, placebo-controlled trial examining treatment effects of combination methytestosterone-thyroid supplementation on male sexual dysfunction.
The language Dr. Jakobovits uses to describe this controversial clinical entity is both flowery and archaic—“climacteric,” “eunuchism.” Men present with “lasitude” and other symptoms we would be hard pressed to associate with LoH, such as tinnitus and palpitations.
In fact, the description of LoH is all that we find distasteful by our present standards and feeds into an outmoded myth—that testosterone deficiency among aging men is the multi-purpose boogey-man, and its correction is a fountain of youth.
…
Kathrins M. (D)evolving attitudes toward late onset hypogonadism. Fertility and Sterility 2020;113:95-6. Redirecting
Although chemotherapy is no complete substitute for psychotherapy in the treatment of impotence of the male patient, nevertheless, in cases where psychologic and/or somatic failure plays a role as etiologic agent then indeed chemotherapy is indicated.
—T. Jakobovits
Our Fertility and Sterility no longer focuses on issues related to the clinical condition variably referred to as andropause, male menopause, or late-onset hypogonadism (LoH). In fact, the Food and Drug Administration, as evidenced by their 2015 Safety Advisory for testosterone supplements, argues that this condition may not even exist.
While this controversy rages on, Dr. Thomas Jakobovits, working in Boston, MA, provides us with evidence for an impressive treatment response to empiric hormonal therapy among such men. Although this article is thin on methodology and scientific rationale, it is a precious double-blind, placebo-controlled trial examining treatment effects of combination methytestosterone-thyroid supplementation on male sexual dysfunction.
The language Dr. Jakobovits uses to describe this controversial clinical entity is both flowery and archaic—“climacteric,” “eunuchism.” Men present with “lasitude” and other symptoms we would be hard pressed to associate with LoH, such as tinnitus and palpitations.
In fact, the description of LoH is all that we find distasteful by our present standards and feeds into an outmoded myth—that testosterone deficiency among aging men is the multi-purpose boogey-man, and its correction is a fountain of youth.
…
Kathrins M. (D)evolving attitudes toward late onset hypogonadism. Fertility and Sterility 2020;113:95-6. Redirecting
[OA] Occurrence of Pulmonary Oil Microembolism After Testosterone Undecanoate Injection
BACKGROUND: The Aveed Risk Evaluation and Mitigation Strategy program was instituted because of potential risk of pulmonary oil microembolism (POME) and/or anaphylaxis after intramuscular injection of Aveed (testosterone undecanoate), indicated for treatment of adult male patients with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
AIM: To analyze the reporting rate of POME associated with testosterone undecanoate administration (750 mg/3 mL) during postmarketing surveillance. METHODS: The Endo Pharmaceuticals Inc database was searched for POME reports occurring from testosterone undecanoate approval on March 5, 2014, through June 30, 2018. Each case was reviewed and adjudicated by a drug safety physician to confirm the reported event had predefined clinical characteristics consistent with POME.
OUTCOMES: Annual rate and clinical features of spontaneously reported POME cases were characterized.
RESULTS: During the 4.3-year period, 90,092 doses of intramuscular testosterone undecanoate were distributed via an Aveed Risk Evaluation and Mitigation Strategy program to health-care professionals for patient treatment.
Of 633 individual case safety reports in the Endo Pharmaceuticals Inc safety database, 28 spontaneously reported adverse events were classified as POME, for a yearly spontaneously reported adverse event per-injection rate of <0.1%. Most (21/22) events resolved, and of those with a resolution time reported, most (13/17) resolved in </=30 minutes. More than 60% (13/21) of patients required no medical intervention (ie, the POME event resolved spontaneously).
One fatality was reported 18 months after a documented POME event and appeared unrelated to the reported testosterone undecanoate injection or subsequent injections after the POME event. In 3 out of 4 POME cases with symptoms serious enough to require an emergency room visit, issues with injection technique or dosing were identified as a potential contributing factor.
CLINICAL IMPLICATIONS: Injection technique and proper product usage are key elements in the prevention of POME events.
STRENGTHS & LIMITATIONS: The reported rate of POME events was determined from a real-world clinical practice patient population; however, postmarketing safety data typically are underreported and retrospective in nature.
CONCLUSION: POME events appear to be rare, with resolution occurring quickly without medical intervention in most cases.
Pastuszak AW, Hu Y, Freid JD. Occurrence of Pulmonary Oil Microembolism After Testosterone Undecanoate Injection: A Postmarketing Safety Analysis. Sex Med 2020. https://www.smoa.jsexmed.org/article/S2050-1161(20)30023-4/fulltext
BACKGROUND: The Aveed Risk Evaluation and Mitigation Strategy program was instituted because of potential risk of pulmonary oil microembolism (POME) and/or anaphylaxis after intramuscular injection of Aveed (testosterone undecanoate), indicated for treatment of adult male patients with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
AIM: To analyze the reporting rate of POME associated with testosterone undecanoate administration (750 mg/3 mL) during postmarketing surveillance. METHODS: The Endo Pharmaceuticals Inc database was searched for POME reports occurring from testosterone undecanoate approval on March 5, 2014, through June 30, 2018. Each case was reviewed and adjudicated by a drug safety physician to confirm the reported event had predefined clinical characteristics consistent with POME.
OUTCOMES: Annual rate and clinical features of spontaneously reported POME cases were characterized.
RESULTS: During the 4.3-year period, 90,092 doses of intramuscular testosterone undecanoate were distributed via an Aveed Risk Evaluation and Mitigation Strategy program to health-care professionals for patient treatment.
Of 633 individual case safety reports in the Endo Pharmaceuticals Inc safety database, 28 spontaneously reported adverse events were classified as POME, for a yearly spontaneously reported adverse event per-injection rate of <0.1%. Most (21/22) events resolved, and of those with a resolution time reported, most (13/17) resolved in </=30 minutes. More than 60% (13/21) of patients required no medical intervention (ie, the POME event resolved spontaneously).
One fatality was reported 18 months after a documented POME event and appeared unrelated to the reported testosterone undecanoate injection or subsequent injections after the POME event. In 3 out of 4 POME cases with symptoms serious enough to require an emergency room visit, issues with injection technique or dosing were identified as a potential contributing factor.
CLINICAL IMPLICATIONS: Injection technique and proper product usage are key elements in the prevention of POME events.
STRENGTHS & LIMITATIONS: The reported rate of POME events was determined from a real-world clinical practice patient population; however, postmarketing safety data typically are underreported and retrospective in nature.
CONCLUSION: POME events appear to be rare, with resolution occurring quickly without medical intervention in most cases.
Pastuszak AW, Hu Y, Freid JD. Occurrence of Pulmonary Oil Microembolism After Testosterone Undecanoate Injection: A Postmarketing Safety Analysis. Sex Med 2020. https://www.smoa.jsexmed.org/article/S2050-1161(20)30023-4/fulltext
CrispyRockClimber
Member
Does this have any relation to Tren-cough?
[OA] NHS Discrimination of Testosterone Deficiency Syndrome
Testosterone deficiency syndrome (TDS), unlike menopausal symptoms, tends not to be managed by general practitioners. Here the author argues that this approach is not logical given that the condition is not rare, and the biological importance of testosterone in men. In addition, there are clear guidelines that enable primary care physicians to meet the needs of TDS patients.
Cervoni E. NHS discrimination of testosterone deficiency syndrome. Trends in Urology & Men's Health 2020;11:23-6. Error - Cookies Turned Off
Testosterone deficiency syndrome (TDS), unlike menopausal symptoms, tends not to be managed by general practitioners. Here the author argues that this approach is not logical given that the condition is not rare, and the biological importance of testosterone in men. In addition, there are clear guidelines that enable primary care physicians to meet the needs of TDS patients.
Cervoni E. NHS discrimination of testosterone deficiency syndrome. Trends in Urology & Men's Health 2020;11:23-6. Error - Cookies Turned Off
“Technique” meaning the depot SITE deviated from the manufactures recommendation.
“Dosing” meaning the depot VOLUME was exceeded the manufactures recommendation.
Both were believed to be contributing factors allowing a large volume of OIL to reach the systemic circulation directly and expeditiously.
The cause of Tren cough is unknown.
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[OA] Efficacy and Safety of Testosterone Therapy Based on Guideline Recommendations
A clinical guideline provides physicians with the convenience of applying an appropriate treatment, but it can prevent physicians from alleviating a patients' worst-case scenarios. Therefore, physicians should strive to formulate a treatment policy by interpreting the common and different parts among guidelines. In this sense, we truly appreciate the recent informative work by Dr. Salter and Dr. Mulhall where they summarized the guidelines for ‘testosterone therapy for testosterone deficiency (TD)’ [1].
Despite the consensus that the effect of testosterone therapy in TD on several symptoms such as sexual function, whether testosterone therapy is advantageous for some areas associated with TD is still inconclusive among guidelines. Very recently, a guideline for testosterone therapy based on a systematic review supported by the American College of Physicians (ACP) was published [2, 3] where the authors recommend testosterone therapy only for enhancing sexual function in TD.
When we reviewed the guidelines [3, 4, 5, 6, 7, 8], the sources of statements on the efficacy and safety of testosterone therapy on several clinical statuses were different from one another; the range of sources was from a handful of systematic reviews to a well-designed randomized controlled trial. …
Lee DS, Park HJ. Efficacy and Safety of Testosterone Therapy Based on Guideline Recommendations; Re: Clinical Practice Guideline by the American College of Physicians [published online ahead of print, 2020 Apr 29]. World J Mens Health. 2020;10.5534/wjmh.200062. doi:10.5534/wjmh.200062 Efficacy and Safety of Testosterone Therapy Based on Guideline Recommendations; Re: Clinical Practice Guideline by the American College of Physicians
A clinical guideline provides physicians with the convenience of applying an appropriate treatment, but it can prevent physicians from alleviating a patients' worst-case scenarios. Therefore, physicians should strive to formulate a treatment policy by interpreting the common and different parts among guidelines. In this sense, we truly appreciate the recent informative work by Dr. Salter and Dr. Mulhall where they summarized the guidelines for ‘testosterone therapy for testosterone deficiency (TD)’ [1].
Despite the consensus that the effect of testosterone therapy in TD on several symptoms such as sexual function, whether testosterone therapy is advantageous for some areas associated with TD is still inconclusive among guidelines. Very recently, a guideline for testosterone therapy based on a systematic review supported by the American College of Physicians (ACP) was published [2, 3] where the authors recommend testosterone therapy only for enhancing sexual function in TD.
When we reviewed the guidelines [3, 4, 5, 6, 7, 8], the sources of statements on the efficacy and safety of testosterone therapy on several clinical statuses were different from one another; the range of sources was from a handful of systematic reviews to a well-designed randomized controlled trial. …
Lee DS, Park HJ. Efficacy and Safety of Testosterone Therapy Based on Guideline Recommendations; Re: Clinical Practice Guideline by the American College of Physicians [published online ahead of print, 2020 Apr 29]. World J Mens Health. 2020;10.5534/wjmh.200062. doi:10.5534/wjmh.200062 Efficacy and Safety of Testosterone Therapy Based on Guideline Recommendations; Re: Clinical Practice Guideline by the American College of Physicians
[OA] Testosterone Deficiency and Risk of Cognitive Disorders
Cognitive impairment and dementia are predicted to undergo a dramatic increase in the following years with more than 131.5 million people being affected by 2030. Although vascular diseases play the most important role in the pathogenesis of memory impairment in aging men, some pre-clinical and clinical evidence has suggested a possible contribution of the age-dependent reduction of testosterone (T).
In this paper we have summarized and discussed all the information derived from available animal and experimental studies. In addition, we meta-analyzed data rising from all randomized placebo controlled trials (RCTs) published so far.
Only limited preclinical and clinical evidence can support a possible contribution of T in the pathogenesis of the age-dependent impairment of cognitive functions. In addition, our meta-analysis did not support the use of T replacement therapy for the improvement of several cognitive domains analyzed including attention/working memory, executive function, language, verbal memory, visual memory, visuomotor ability, and visuospatial ability.
However, it is important to recognize that the vast majority of available RCTs included mixed populations of subjects with eugonadism and hypogonadism preventing any final conclusion being drawn on these issues.
Corona G, Guaraldi F, Rastrelli G, Sforza A, Maggi M. Testosterone Deficiency and Risk of Cognitive Disorders in Aging Males [published online ahead of print, 2020 Apr 1]. World J Mens Health. 2020;10.5534/wjmh.200017. doi:10.5534/wjmh.200017 Testosterone Deficiency and Risk of Cognitive Disorders in Aging Males
Cognitive impairment and dementia are predicted to undergo a dramatic increase in the following years with more than 131.5 million people being affected by 2030. Although vascular diseases play the most important role in the pathogenesis of memory impairment in aging men, some pre-clinical and clinical evidence has suggested a possible contribution of the age-dependent reduction of testosterone (T).
In this paper we have summarized and discussed all the information derived from available animal and experimental studies. In addition, we meta-analyzed data rising from all randomized placebo controlled trials (RCTs) published so far.
Only limited preclinical and clinical evidence can support a possible contribution of T in the pathogenesis of the age-dependent impairment of cognitive functions. In addition, our meta-analysis did not support the use of T replacement therapy for the improvement of several cognitive domains analyzed including attention/working memory, executive function, language, verbal memory, visual memory, visuomotor ability, and visuospatial ability.
However, it is important to recognize that the vast majority of available RCTs included mixed populations of subjects with eugonadism and hypogonadism preventing any final conclusion being drawn on these issues.
Corona G, Guaraldi F, Rastrelli G, Sforza A, Maggi M. Testosterone Deficiency and Risk of Cognitive Disorders in Aging Males [published online ahead of print, 2020 Apr 1]. World J Mens Health. 2020;10.5534/wjmh.200017. doi:10.5534/wjmh.200017 Testosterone Deficiency and Risk of Cognitive Disorders in Aging Males
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Nothing to do with the oil, the volume, or the injection technique, people used to get the cough when applying transdermally tren powder mixed in DMSO too.
[OA] Testosterone Therapy in Adolescent Boys: The Need for a Structured Approach
Background: In adolescents, testosterone may have several effects including promotion of secondary sexual characteristics and pubertal growth, attainment of optimal muscle mass and peak bone mass, optimization of the metabolic profile, and psychosocial maturation and well-being.
Summary: Testosterone therapy is a cornerstone of the management of hypogonadism in boys. Since the initial report of the chemical synthesis of testosterone, several formulations have continued to develop, and although many of these have been used in boys, none of them have been studied in detail in this age group. Given the wide ranging effects of testosterone, the level of evidence for their effects in boys and the heterogeneity of conditions that lead to early-onset hypogonadism, a standardized protocol for monitoring testosterone replacement in this age group is needed.
Key Messages: In this review, we focus on the perceived benefits of androgen replacement in boys affected by pubertal delay and highlight the need to improve the health monitoring of boys who receive androgen replacement therapy, proposing different approaches based on the underlying pathophysiology.
Stancampiano MR, Lucas-Herald AK, Russo G, Rogol AD, Ahmed SF. Testosterone Therapy in Adolescent Boys: The Need for a Structured Approach. Horm Res Paediatr. 2019;92(4):215‐228. doi:10.1159/000504670 Testosterone Therapy in Adolescent Boys: The Need for a Structured Approach
Background: In adolescents, testosterone may have several effects including promotion of secondary sexual characteristics and pubertal growth, attainment of optimal muscle mass and peak bone mass, optimization of the metabolic profile, and psychosocial maturation and well-being.
Summary: Testosterone therapy is a cornerstone of the management of hypogonadism in boys. Since the initial report of the chemical synthesis of testosterone, several formulations have continued to develop, and although many of these have been used in boys, none of them have been studied in detail in this age group. Given the wide ranging effects of testosterone, the level of evidence for their effects in boys and the heterogeneity of conditions that lead to early-onset hypogonadism, a standardized protocol for monitoring testosterone replacement in this age group is needed.
Key Messages: In this review, we focus on the perceived benefits of androgen replacement in boys affected by pubertal delay and highlight the need to improve the health monitoring of boys who receive androgen replacement therapy, proposing different approaches based on the underlying pathophysiology.
Stancampiano MR, Lucas-Herald AK, Russo G, Rogol AD, Ahmed SF. Testosterone Therapy in Adolescent Boys: The Need for a Structured Approach. Horm Res Paediatr. 2019;92(4):215‐228. doi:10.1159/000504670 Testosterone Therapy in Adolescent Boys: The Need for a Structured Approach
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