Dr. Khera highlights TRAVERSE trial of testosterone replacement therapy

[madman]

"So far, we have only 2 published, which is the cardiovascular results, which showed no increase in cardiovascular events, and the sexual function results, showing improvements in libido, but not erectile function, in up to 2 years," says Mohit Khera, MD, MBA, MPH.

Dr. Khera highlights TRAVERSE trial of testosterone replacement therapy

"So far, we have only 2 published, which is the cardiovascular results, which showed no increase in cardiovascular events, and the sexual function results, showing improvements in libido, but not erectile function, in up to 2 years," says Mohit Khera, MD, MBA, MPH.

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[madman]

Testosterone and Cardiovascular Disease (Traverse Trial)

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[madman]

New and emergent preparations for male hypogonadism treatment

ABSTRACT Introduction The specific role of testosterone (T) replacement therapy in patients with late-onset hypogonadism is still conflicting. Several available preparations have been developed to restore either fertility and normal testosterone (T) levels (secondary hypogonadism) or just T...

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TRAVERSE/CVD

*However, it should be recognized that the long-term CV safety of TRT still represents a conflicting issue. One of the most recent meta-analyses showed that TRT does not increase short-term or medium-term CV risk in men with hypogonadism [69]. The same study emphasized the paucity of data evaluating TRT-related long-term CV safety. In addition, although the TRAVERSE study did not report any differences in MACE risk after 2 years of treatment, a mild, although significant, increased risk of arrhythmias, and atrial fibrillation, in particular, as well as of venous thromboembolism, has been reported in the active arm when compared to placebo [23]. The high (>60%) dropout observed during the study and the lack of formal adjudication of the latter events, which were secondary endpoints (venous thromboembolism) and investigator-reported (arrhythmias), represent crucial bias in the data interpretation [23].

 

[Nelson Vergel]

Of 5,204 randomized participants, 2,643 (50.8%) had significant depressive symptoms, but only 49 (1.5%) met rigorous criteria for LG-PDD. Among those with LG-PDD, there was no significant difference in any outcome measure between the TRT and placebo groups, possibly reflecting low statistical power. In men with significant depressive symptoms n=2643) and in all randomized participants (n=5204), TRT was associated with modest but significantly greater improvements in mood and energy but not cognition or sleep quality.

Depressive Syndromes in Men with Hypogonadism in the TRAVERSE Trial: Response to Testosterone Replacement Therapy

AbstractContext. The effect of testosterone on depressive symptoms in men with hypogonadism remains incompletely understood.Objective. We assessed the effects o

academic.oup.com

 

[madman]

Testosterone Therapy and the Risk of Cardiovascular Disease

Abstract The debate over the cardiovascular (CV) implications of testosterone therapy (TT) have resulted in diverging safety recommendations and clinical guidelines worldwide. This narrative review synthesizes and critically evaluates long-term studies examining the effects of TT within the...

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4. Conclusion

The therapeutic approach for TT for symptomatic hypogonadism and low testosterone levels associated with aging, obesity, and systemic illness presents challenges. These conditions are intricately linked with CVD outcomes and may confound the relationship between low testosterone and CVD. Although observational studies suggest an association between low testosterone and increased risk of CVD, results from testosterone supplementation are inconsistent. RCTs indicate that short-term TT at standard replacement is not associated with increased CVD risk. Nevertheless, the cardiovascular sub-study of T Trials observed increases in NCP and CAC, signaling the need for further investigation into potential long-term implications of TT.

The TRAVERSE trial, a landmark study unique in its capacity to evaluate CVD events, contributes valuable insights into the short-term safety of TT at lower physiological levels. However, the long-term effects and implications of mid to high physiological testosterone levels are not yet fully understood. The trials’ limitations — achievement of only low-normal testosterone levels, high discontinuation rates, brief follow-up period, and high loss to follow-up rate — suggest that the findings should be interpreted with caution. It is important to avoid generalizing the safety of TT based on these results alone and to approach the extrapolation of TRAVERSE’s conclusions to higher dosages or longer-term therapy with caution.

The decision to initiate TT requires a nuanced approach, which must account for current gaps in evidence regarding CV safety. A personalized assessment and management of CVD risk factors is essential for older men with known CVD. The CV effects of exogenous testosterone, when given to maintain physiological levels, remain to be fully explored. In this regard, an important question remains the identification of male patients with symptomatic hypogonadism who may benefit from TT. This topic continues to be the subject of ongoing debate. Hopefully, future trials will provide clarity on whether TT confers beneficial, neutral, or adverse cardiovascular effects in middle-aged and older men. Until definitive evidence surfaces, clinical practice should exercise caution and prioritize individualized care with informed discussions regarding the potential CV implications of TT.