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The American Association of Clinical Endocrinologists (AACE) has issued a position statement questioning claims that testosterone replacement therapy (TRT) increases the risk of cardiovascular disease among users. The position statement is published in the September 2015 edition of Endocrine Practice.
The position statement notes that low testosterone is often a marker for cardiovascular illness, not a causal factor, and that TRT in men with cardiovascular risk factors can be beneficial. TRT use has been associated with a decrease in fat mass, an increase in muscle mass, decreased insulin resistance, and a reversal of metabolic syndrome in some patients. However, these benefits can only be assessed and supported in patients with documented hypogonadism.
The AACE believes that even after extensive literature review, there is no compelling evidence to suggest that TRT increases cardiovascular risk, with the FDA even concluding that the “signal of cardiovascular risk is weak”. In March 2015, the FDA had all manufacturers of TRT update their prescribing information to clarify the approved use of these medications and to inform clinicians of the possible increased risk of heart attacks and strokes in patients taking testosterone.
RELATED: FDA: Testosterone Replacement Tx Review Prompts New Warnings, Updated Labeling
To determine the impact of TRT on cardiovascular disease risk, the AACE is recommending large-scale studies focusing on controlled trials. In the meanwhile, AACE recommends TRT clinical decisions be guided by the individual patients’ signs and symptoms and testosterone concentrations rather than the underlying cause of low testosterone such as aging. Clinicians should discuss the available evidence with patients so they are aware of the risks and benefits before starting TRT replacement.
The entire AACE position statement can be found here.
