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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
TRAVERSE: Testosterone and Cardiovascular Safety
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<blockquote data-quote="madman" data-source="post: 266102" data-attributes="member: 13851"><p>Much more to look into!</p><p></p><p><strong>The authors reply:</strong> <em><strong><u>We agree with Huang et al. that the relationship between circulating testosterone levels and the risk of atrial fibrillation remains unclear</u>.</strong> The FINRISK study1 showed a weak negative association between baseline testosterone levels and the risk of atrial fibrillation or stroke (a composite end point), whereas the Atherosclerosis Risk in Communities (ARIC) study2 showed a positive association between testosterone levels and incident atrial fibrillation. <strong>A meta-analysis did not show a significant difference between testosterone treatment and placebo with respect to the incidence of cardiac arrhythmias among men.3 <u>We agree that more detailed post hoc analyses of the data, including subgroup analyses, may help generate exploratory hypotheses for future studies</u>.</strong></em></p><p><em><strong></strong></em></p><p><em><strong><u>The narrow target range of testosterone levels mentioned by Malozowski and Reboussin is not recommended by the Endocrine Society guidelines, which suggest that clinicians aim to attain testosterone values in the mid-normal range</u>.4 <strong>Testosterone levels during treatment vary substantially at different times of the day and on different days in the same person, which makes it difficult to maintain testosterone levels continuously within the narrow limits mentioned, even if average 24-hour concentrations are within the normal range. <u>Testosterone levels in the TRAVERSE trial were measured at the nadir during therapy (24 hours after the last dose)</u>.</strong> <strong><u>Nadir levels are 30 to 40% lower than the peak levels 2 to 8 hours after gel application</u>. <u>Because the trial was intended to rule out a cardiovascular hazard, the efficacy data was reserved for subsequent manuscripts</u>. <u>We agree that the reported safety data, along with the efficacy data, will facilitate a more informed appraisal of the potential benefits and risks of testosterone-replacement therapy</u>.</strong></strong></em></p><p><em><strong><strong></strong></strong></em></p><p><em><strong><strong>Grossman and Zajac express concern about whether the patients in our trial were truly hypogonadal. Patients were enrolled in the trial if they met the criteria established by the Endocrine Society guidelines for the diagnosis of hypogonadism.4 Patients were required to have one or more symptoms of hypogonadism and two fasting, morning testosterone levels of less than 300 ng per deciliter. <u>We agree that some of the symptoms of hypogonadism, such as fatigue, can be nonspecific and overlap with other chronic diseases</u>. Eligibility criteria included the presence of preexisting cardiovascular disease or three or more cardiovascular risk factors, which resulted in a high percentage of men with obesity, diabetes, or both — a prevalence that is similar to that among hypogonadal men receiving testosterone treatment in the United States.5 <u>The results of the trial do not preclude the need for management of diabetes, obesity, sleep apnea, clinical depression, or other coexisting conditions before considering testosterone-replacement therapy</u>.</strong></strong></em></p><p></p><p></p><p><strong>Shalender Bhasin, M.B., B.S.</strong></p><p>Brigham and Women’s Hospital</p><p>Boston, MA</p><p></p><p><strong>A. Michael Lincoff, M.D.</strong></p><p><strong>Steven E. Nissen, M.D.</strong></p><p>Cleveland Clinic</p><p>Cleveland, OH</p><p></p><p>[URL unfurl="true"]https://www.excelmale.com/forum/threads/traverse-cardiovascular-safety-of-tth.28521/[/URL]</p></blockquote><p></p>
[QUOTE="madman, post: 266102, member: 13851"] Much more to look into! [B]The authors reply:[/B] [I][B][U]We agree with Huang et al. that the relationship between circulating testosterone levels and the risk of atrial fibrillation remains unclear[/U].[/B] The FINRISK study1 showed a weak negative association between baseline testosterone levels and the risk of atrial fibrillation or stroke (a composite end point), whereas the Atherosclerosis Risk in Communities (ARIC) study2 showed a positive association between testosterone levels and incident atrial fibrillation. [B]A meta-analysis did not show a significant difference between testosterone treatment and placebo with respect to the incidence of cardiac arrhythmias among men.3 [U]We agree that more detailed post hoc analyses of the data, including subgroup analyses, may help generate exploratory hypotheses for future studies[/U]. [U]The narrow target range of testosterone levels mentioned by Malozowski and Reboussin is not recommended by the Endocrine Society guidelines, which suggest that clinicians aim to attain testosterone values in the mid-normal range[/U].4 [B]Testosterone levels during treatment vary substantially at different times of the day and on different days in the same person, which makes it difficult to maintain testosterone levels continuously within the narrow limits mentioned, even if average 24-hour concentrations are within the normal range. [U]Testosterone levels in the TRAVERSE trial were measured at the nadir during therapy (24 hours after the last dose)[/U].[/B] [B][U]Nadir levels are 30 to 40% lower than the peak levels 2 to 8 hours after gel application[/U]. [U]Because the trial was intended to rule out a cardiovascular hazard, the efficacy data was reserved for subsequent manuscripts[/U]. [U]We agree that the reported safety data, along with the efficacy data, will facilitate a more informed appraisal of the potential benefits and risks of testosterone-replacement therapy[/U]. Grossman and Zajac express concern about whether the patients in our trial were truly hypogonadal. Patients were enrolled in the trial if they met the criteria established by the Endocrine Society guidelines for the diagnosis of hypogonadism.4 Patients were required to have one or more symptoms of hypogonadism and two fasting, morning testosterone levels of less than 300 ng per deciliter. [U]We agree that some of the symptoms of hypogonadism, such as fatigue, can be nonspecific and overlap with other chronic diseases[/U]. Eligibility criteria included the presence of preexisting cardiovascular disease or three or more cardiovascular risk factors, which resulted in a high percentage of men with obesity, diabetes, or both — a prevalence that is similar to that among hypogonadal men receiving testosterone treatment in the United States.5 [U]The results of the trial do not preclude the need for management of diabetes, obesity, sleep apnea, clinical depression, or other coexisting conditions before considering testosterone-replacement therapy[/U].[/B][/B][/I] [B]Shalender Bhasin, M.B., B.S.[/B] Brigham and Women’s Hospital Boston, MA [B]A. Michael Lincoff, M.D. Steven E. Nissen, M.D.[/B] Cleveland Clinic Cleveland, OH [URL unfurl="true"]https://www.excelmale.com/forum/threads/traverse-cardiovascular-safety-of-tth.28521/[/URL] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
TRAVERSE: Testosterone and Cardiovascular Safety
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