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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
An update on heart disease risk associated with testosterone boosting medications
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<blockquote data-quote="madman" data-source="post: 147693" data-attributes="member: 13851"><p><strong>Abstract</strong></p><p></p><p><strong><span style="color: rgb(184, 49, 47)">Introduction:</span></strong> The cardiovascular (CV) safety of testosterone replacement therapy (TRT) remains a crucial issue in the management of subjects with late onset hypogonadism. <strong>The authors systematically reviewed and discussed the available evidence focusing our analysis on heart related issues.</strong></p><p></p><p><strong><span style="color: rgb(184, 49, 47)">Areas covered:</span></strong> All the available data from prospective observational studies evaluating the role endogenous T levels on the risk of acute myocardial infarction (AMI) were collected and analyzed. In addition, the impact of TRT on heart related diseases, as derived from pharmaco-epidemiological studies as well as from randomized placebo controlled trials (RCTs), was also investigated.</p><p></p><p><strong><span style="color: rgb(184, 49, 47)">Expert opinion: </span></strong></p><p><strong>Available<span style="color: rgb(184, 49, 47)"> evidence</span> indicates that <span style="color: rgb(184, 49, 47)">endogenous low T</span> represents <span style="color: rgb(184, 49, 47)">a risk factor of AMI incidence</span> and <span style="color: rgb(184, 49, 47)">its related mortality</span>. <span style="color: rgb(184, 49, 47)">TRT in hypogonadal patients </span>is able to <span style="color: rgb(184, 49, 47)">improve angina symptoms</span> in subjects with <span style="color: rgb(184, 49, 47)">ischemic heart diseases </span>and <span style="color: rgb(184, 49, 47)">exercise ability</span> in patients with <span style="color: rgb(184, 49, 47)">heart failure (HF)</span>. In addition, when <span style="color: rgb(44, 130, 201)">prescribed </span>according to <span style="color: rgb(44, 130, 201)">the recommended dosage</span>, <span style="color: rgb(44, 130, 201)">TRT does not increase the risk of heart-related events. </span></strong></p><p></p><p></p><p></p><p><strong><span style="color: rgb(184, 49, 47)">Article highlights </span></strong></p><p></p><p>• <span style="color: rgb(0, 0, 0)"><strong>Low endogenous testosterone (T) is </strong></span><span style="color: rgb(184, 49, 47)"><strong>associated with an increased risk of acute myocardial infarction (AMI)-related mortality and AMI incidence.</strong></span></p><p></p><p>• <strong><span style="color: rgb(0, 0, 0)">Testosterone replacement therapy (TRT) in hypogonadal patients is able to </span><span style="color: rgb(184, 49, 47)">improve angina symptoms in subjects with ischemic heart diseases and exercise ability in patients with heart failure. </span></strong></p><p></p><p><span style="color: rgb(0, 0, 0)">• </span><strong><span style="color: rgb(0, 0, 0)">In 2014, the European Medical Agency (EMA) </span><span style="color: rgb(184, 49, 47)">did not share the FDA’s opinion of an increased CV risk linked to T medication</span><span style="color: rgb(0, 0, 0)">, because of </span><span style="color: rgb(44, 130, 201)">the lack of convincing evidence.</span> </strong></p><p></p><p>• <span style="color: rgb(0, 0, 0)"><strong>The analysis of </strong></span><span style="color: rgb(44, 130, 201)"><strong>all randomized placebo controlled controlled trials</strong></span> <span style="color: rgb(0, 0, 0)"><strong>showed that when prescribed according to the recommended dosage, </strong></span><span style="color: rgb(44, 130, 201)"><strong>TRT does not increase the risk of heart-related events</strong></span><span style="color: rgb(0, 0, 0)"><strong>. </strong></span></p><p></p><p></p><p></p><p></p><p></p><p></p><p><strong><span style="color: rgb(184, 49, 47)">4.0</span></strong> <strong><span style="color: rgb(0, 0, 0)">Conclusions </span></strong></p><p></p><p><strong>The <span style="color: rgb(184, 49, 47)">studies critically scrutinized here</span> clearly show that</strong><span style="color: rgb(184, 49, 47)"><strong> low T is a marker of poor CV outcomes, including CAD</strong></span><strong>. Meta-analysis of retrospective observational studies <span style="color: rgb(184, 49, 47)">suggest that correcting T deficiency marginally improves cardiac outcomes</span>. However, <span style="color: rgb(184, 49, 47)">many of the weaknesses linked to pharmaco-epidemiological studies</span>, here discussed, <span style="color: rgb(184, 49, 47)">hamper confidence</span> in this conclusion.</strong> <span style="color: rgb(0, 0, 0)"><strong>Meta-analysis of interventional studies having cardiac outcomes as a primary end-point </strong></span><span style="color: rgb(184, 49, 47)"><strong>suggest an acute and chronic positive effect of TRT on increasing time to ST-segment depression and in some measures of HF</strong></span><span style="color: rgb(0, 0, 0)"><strong>. However, all these studies were of </strong></span><span style="color: rgb(184, 49, 47)"><strong>short duration and enrolling a limited number of subjects</strong></span><span style="color: rgb(0, 0, 0)"><strong> and therefore they are</strong></span><span style="color: rgb(184, 49, 47)"><strong> underpowered</strong></span><span style="color: rgb(0, 0, 0)"><strong>. In addition, they may have </strong></span><span style="color: rgb(184, 49, 47)"><strong>overlooked early positive transient effects</strong></span><span style="color: rgb(0, 0, 0)"><strong>. </strong></span><strong><span style="color: rgb(0, 0, 0)">Nevertheless, prospective studies of </span><span style="color: rgb(184, 49, 47)">longer duration enrolling hypogonadal subjects having cardiac safety as a primary end-point are difficult to realize, due to </span><span style="color: rgb(44, 130, 201)">ethical reasons</span></strong>.<strong><span style="color: rgb(0, 0, 0)"> For all these reasons, we here summarize in </span><span style="color: rgb(184, 49, 47)">Forest plots results from different meta-analyses </span><span style="color: rgb(0, 0, 0)">of available </span><span style="color: rgb(44, 130, 201)">RCTs not having cardiac outcomes as an endpoint</span><span style="color: rgb(0, 0, 0)">, but reporting information on them.</span></strong> <span style="color: rgb(0, 0, 0)"><strong>Overall, included trials were of </strong></span><span style="color: rgb(184, 49, 47)"><strong>low-to-medium quality</strong></span><span style="color: rgb(0, 0, 0)"><strong>, </strong></span><span style="color: rgb(184, 49, 47)"><strong>enrolling subjects with variable characteristics</strong></span><span style="color: rgb(0, 0, 0)"><strong>, using different </strong></span><span style="color: rgb(184, 49, 47)"><strong>TRT protocols for various duration </strong></span><span style="color: rgb(0, 0, 0)"><strong>and, again, </strong></span><span style="color: rgb(44, 130, 201)"><strong>not powered to evaluate cardiac events</strong></span><span style="color: rgb(0, 0, 0)"><strong>. </strong></span><strong><span style="color: rgb(0, 0, 0)">Meta-analysis is particularly useful when there are </span><span style="color: rgb(184, 49, 47)">a variety of reports with low statistical power</span><span style="color: rgb(0, 0, 0)">; thus, </span><span style="color: rgb(184, 49, 47)">pooling data can improve power and provide a convincing result</span></strong>. <strong><span style="color: rgb(0, 0, 0)">All the different meta-analyses indicate that there is </span><span style="color: rgb(44, 130, 201)">no significant risk for TRT in several cardiac outcomes</span><span style="color: rgb(0, 0, 0)">, including </span><span style="color: rgb(44, 130, 201)">AMI and acute coronary syndrome</span><span style="color: rgb(0, 0, 0)">.</span></strong> <strong>It is important to recognize that all the <span style="color: rgb(184, 49, 47)">available trials included in the meta-analyses</span> have a relatively <span style="color: rgb(44, 130, 201)">short duration</span>, lasting at maximum <span style="color: rgb(44, 130, 201)">three years</span>.</strong> <strong>Therefore, although there is <span style="color: rgb(44, 130, 201)">no clear sign of risk in the short term</span>, <span style="color: rgb(184, 49, 47)">no information is available on </span><span style="color: rgb(44, 130, 201)">possible long-term effects</span>. Considering that <span style="color: rgb(184, 49, 47)">TRT is meant to be a lifelong treatment in the majority of cases</span> the last issue is <span style="color: rgb(44, 130, 201)">a relevant point</span>.</strong> <strong><span style="color: rgb(26, 188, 156)">In conclusion, five years later, we fully endorse the EMA statement concerning TRT saying: “evidence regarding the risk of heart problems was inconsistent” (12).</span> A new trial <span style="color: rgb(184, 49, 47)">(TRAVERSE; clinicaltrials.gov, NCT03518034)</span> to evaluate the effect of TRT on the incidence of <span style="color: rgb(184, 49, 47)">MACE and efficacy measures</span> in men with hypogonadism is ongoing. </strong><span style="color: rgb(44, 130, 201)"><strong>This is the first TRT trial with adequate power to assess CV events in hypogonadal population and it will give important information on this topic in the near future.</strong></span></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p>Important point for everyone to keep in mind!</p><p></p><p></p><p><strong><span style="color: rgb(184, 49, 47)">*</span></strong> <strong> A new trial <span style="color: rgb(184, 49, 47)">(TRAVERSE; clinicaltrials.gov, NCT03518034)</span> to evaluate the effect of TRT on the incidence of <span style="color: rgb(184, 49, 47)">MACE and efficacy measures</span> in men with hypogonadism is ongoing. </strong><span style="color: rgb(44, 130, 201)"><strong>This is the </strong></span><span style="color: rgb(184, 49, 47)"><strong>first TRT trial </strong></span><span style="color: rgb(44, 130, 201)"><strong>with </strong></span><span style="color: rgb(184, 49, 47)"><strong>adequate power</strong></span><span style="color: rgb(44, 130, 201)"><strong> to assess</strong></span><span style="color: rgb(184, 49, 47)"><strong> CV events in hypogonadal population</strong></span><span style="color: rgb(44, 130, 201)"><strong> and it will give </strong></span><span style="color: rgb(184, 49, 47)"><strong>important information</strong></span><span style="color: rgb(44, 130, 201)"><strong> on this topic in the near future.</strong></span></p></blockquote><p></p>
[QUOTE="madman, post: 147693, member: 13851"] [B]Abstract[/B] [B][COLOR=rgb(184, 49, 47)]Introduction:[/COLOR][/B] The cardiovascular (CV) safety of testosterone replacement therapy (TRT) remains a crucial issue in the management of subjects with late onset hypogonadism. [B]The authors systematically reviewed and discussed the available evidence focusing our analysis on heart related issues.[/B] [B][COLOR=rgb(184, 49, 47)]Areas covered:[/COLOR][/B] All the available data from prospective observational studies evaluating the role endogenous T levels on the risk of acute myocardial infarction (AMI) were collected and analyzed. In addition, the impact of TRT on heart related diseases, as derived from pharmaco-epidemiological studies as well as from randomized placebo controlled trials (RCTs), was also investigated. [B][COLOR=rgb(184, 49, 47)]Expert opinion: [/COLOR] Available[COLOR=rgb(184, 49, 47)] evidence[/COLOR] indicates that [COLOR=rgb(184, 49, 47)]endogenous low T[/COLOR] represents [COLOR=rgb(184, 49, 47)]a risk factor of AMI incidence[/COLOR] and [COLOR=rgb(184, 49, 47)]its related mortality[/COLOR]. [COLOR=rgb(184, 49, 47)]TRT in hypogonadal patients [/COLOR]is able to [COLOR=rgb(184, 49, 47)]improve angina symptoms[/COLOR] in subjects with [COLOR=rgb(184, 49, 47)]ischemic heart diseases [/COLOR]and [COLOR=rgb(184, 49, 47)]exercise ability[/COLOR] in patients with [COLOR=rgb(184, 49, 47)]heart failure (HF)[/COLOR]. In addition, when [COLOR=rgb(44, 130, 201)]prescribed [/COLOR]according to [COLOR=rgb(44, 130, 201)]the recommended dosage[/COLOR], [COLOR=rgb(44, 130, 201)]TRT does not increase the risk of heart-related events. [/COLOR][/B] [B][COLOR=rgb(184, 49, 47)]Article highlights [/COLOR][/B] • [COLOR=rgb(0, 0, 0)][B]Low endogenous testosterone (T) is [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]associated with an increased risk of acute myocardial infarction (AMI)-related mortality and AMI incidence.[/B][/COLOR] • [B][COLOR=rgb(0, 0, 0)]Testosterone replacement therapy (TRT) in hypogonadal patients is able to [/COLOR][COLOR=rgb(184, 49, 47)]improve angina symptoms in subjects with ischemic heart diseases and exercise ability in patients with heart failure. [/COLOR][/B] [COLOR=rgb(0, 0, 0)]• [/COLOR][B][COLOR=rgb(0, 0, 0)]In 2014, the European Medical Agency (EMA) [/COLOR][COLOR=rgb(184, 49, 47)]did not share the FDA’s opinion of an increased CV risk linked to T medication[/COLOR][COLOR=rgb(0, 0, 0)], because of [/COLOR][COLOR=rgb(44, 130, 201)]the lack of convincing evidence.[/COLOR] [/B] • [COLOR=rgb(0, 0, 0)][B]The analysis of [/B][/COLOR][COLOR=rgb(44, 130, 201)][B]all randomized placebo controlled controlled trials[/B][/COLOR] [COLOR=rgb(0, 0, 0)][B]showed that when prescribed according to the recommended dosage, [/B][/COLOR][COLOR=rgb(44, 130, 201)][B]TRT does not increase the risk of heart-related events[/B][/COLOR][COLOR=rgb(0, 0, 0)][B]. [/B][/COLOR] [B][COLOR=rgb(184, 49, 47)]4.0[/COLOR][/B] [B][COLOR=rgb(0, 0, 0)]Conclusions [/COLOR][/B] [B]The [COLOR=rgb(184, 49, 47)]studies critically scrutinized here[/COLOR] clearly show that[/B][COLOR=rgb(184, 49, 47)][B] low T is a marker of poor CV outcomes, including CAD[/B][/COLOR][B]. Meta-analysis of retrospective observational studies [COLOR=rgb(184, 49, 47)]suggest that correcting T deficiency marginally improves cardiac outcomes[/COLOR]. However, [COLOR=rgb(184, 49, 47)]many of the weaknesses linked to pharmaco-epidemiological studies[/COLOR], here discussed, [COLOR=rgb(184, 49, 47)]hamper confidence[/COLOR] in this conclusion.[/B] [COLOR=rgb(0, 0, 0)][B]Meta-analysis of interventional studies having cardiac outcomes as a primary end-point [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]suggest an acute and chronic positive effect of TRT on increasing time to ST-segment depression and in some measures of HF[/B][/COLOR][COLOR=rgb(0, 0, 0)][B]. However, all these studies were of [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]short duration and enrolling a limited number of subjects[/B][/COLOR][COLOR=rgb(0, 0, 0)][B] and therefore they are[/B][/COLOR][COLOR=rgb(184, 49, 47)][B] underpowered[/B][/COLOR][COLOR=rgb(0, 0, 0)][B]. In addition, they may have [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]overlooked early positive transient effects[/B][/COLOR][COLOR=rgb(0, 0, 0)][B]. [/B][/COLOR][B][COLOR=rgb(0, 0, 0)]Nevertheless, prospective studies of [/COLOR][COLOR=rgb(184, 49, 47)]longer duration enrolling hypogonadal subjects having cardiac safety as a primary end-point are difficult to realize, due to [/COLOR][COLOR=rgb(44, 130, 201)]ethical reasons[/COLOR][/B].[B][COLOR=rgb(0, 0, 0)] For all these reasons, we here summarize in [/COLOR][COLOR=rgb(184, 49, 47)]Forest plots results from different meta-analyses [/COLOR][COLOR=rgb(0, 0, 0)]of available [/COLOR][COLOR=rgb(44, 130, 201)]RCTs not having cardiac outcomes as an endpoint[/COLOR][COLOR=rgb(0, 0, 0)], but reporting information on them.[/COLOR][/B] [COLOR=rgb(0, 0, 0)][B]Overall, included trials were of [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]low-to-medium quality[/B][/COLOR][COLOR=rgb(0, 0, 0)][B], [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]enrolling subjects with variable characteristics[/B][/COLOR][COLOR=rgb(0, 0, 0)][B], using different [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]TRT protocols for various duration [/B][/COLOR][COLOR=rgb(0, 0, 0)][B]and, again, [/B][/COLOR][COLOR=rgb(44, 130, 201)][B]not powered to evaluate cardiac events[/B][/COLOR][COLOR=rgb(0, 0, 0)][B]. [/B][/COLOR][B][COLOR=rgb(0, 0, 0)]Meta-analysis is particularly useful when there are [/COLOR][COLOR=rgb(184, 49, 47)]a variety of reports with low statistical power[/COLOR][COLOR=rgb(0, 0, 0)]; thus, [/COLOR][COLOR=rgb(184, 49, 47)]pooling data can improve power and provide a convincing result[/COLOR][/B]. [B][COLOR=rgb(0, 0, 0)]All the different meta-analyses indicate that there is [/COLOR][COLOR=rgb(44, 130, 201)]no significant risk for TRT in several cardiac outcomes[/COLOR][COLOR=rgb(0, 0, 0)], including [/COLOR][COLOR=rgb(44, 130, 201)]AMI and acute coronary syndrome[/COLOR][COLOR=rgb(0, 0, 0)].[/COLOR][/B] [B]It is important to recognize that all the [COLOR=rgb(184, 49, 47)]available trials included in the meta-analyses[/COLOR] have a relatively [COLOR=rgb(44, 130, 201)]short duration[/COLOR], lasting at maximum [COLOR=rgb(44, 130, 201)]three years[/COLOR].[/B] [B]Therefore, although there is [COLOR=rgb(44, 130, 201)]no clear sign of risk in the short term[/COLOR], [COLOR=rgb(184, 49, 47)]no information is available on [/COLOR][COLOR=rgb(44, 130, 201)]possible long-term effects[/COLOR]. Considering that [COLOR=rgb(184, 49, 47)]TRT is meant to be a lifelong treatment in the majority of cases[/COLOR] the last issue is [COLOR=rgb(44, 130, 201)]a relevant point[/COLOR].[/B] [B][COLOR=rgb(26, 188, 156)]In conclusion, five years later, we fully endorse the EMA statement concerning TRT saying: “evidence regarding the risk of heart problems was inconsistent” (12).[/COLOR] A new trial [COLOR=rgb(184, 49, 47)](TRAVERSE; clinicaltrials.gov, NCT03518034)[/COLOR] to evaluate the effect of TRT on the incidence of [COLOR=rgb(184, 49, 47)]MACE and efficacy measures[/COLOR] in men with hypogonadism is ongoing. [/B][COLOR=rgb(44, 130, 201)][B]This is the first TRT trial with adequate power to assess CV events in hypogonadal population and it will give important information on this topic in the near future.[/B][/COLOR] Important point for everyone to keep in mind! [B][COLOR=rgb(184, 49, 47)]*[/COLOR][/B] [B] A new trial [COLOR=rgb(184, 49, 47)](TRAVERSE; clinicaltrials.gov, NCT03518034)[/COLOR] to evaluate the effect of TRT on the incidence of [COLOR=rgb(184, 49, 47)]MACE and efficacy measures[/COLOR] in men with hypogonadism is ongoing. [/B][COLOR=rgb(44, 130, 201)][B]This is the [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]first TRT trial [/B][/COLOR][COLOR=rgb(44, 130, 201)][B]with [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]adequate power[/B][/COLOR][COLOR=rgb(44, 130, 201)][B] to assess[/B][/COLOR][COLOR=rgb(184, 49, 47)][B] CV events in hypogonadal population[/B][/COLOR][COLOR=rgb(44, 130, 201)][B] and it will give [/B][/COLOR][COLOR=rgb(184, 49, 47)][B]important information[/B][/COLOR][COLOR=rgb(44, 130, 201)][B] on this topic in the near future.[/B][/COLOR] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
An update on heart disease risk associated with testosterone boosting medications
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