World J Mens Health.  2015 Dec;33(3):130-142. 10.5534/wjmh.2015.33.3.130.

Testosterone Replacement Therapy and Cardiovascular Risk: A Review

• Corona G G
• Rastrelli
• Maseroli E
• Sforza A
• Maggi M

• KMID: 2405141
• DOI: http://doi.org/10.5534/wjmh.2015.33.3.130

Abstract

Recent reports in the scientific and lay press have suggested that testosterone (T) replacement therapy (TRT) is likely to increase cardiovascular (CV) risk. In a final report released in 2015, the Food and Drug Administration (FDA) cautioned that prescribing T products is approved only for men who have low T levels due to primary or secondary hypogonadism resulting from problems within the testis, pituitary, or hypothalamus (e.g., genetic problems or damage from surgery, chemotherapy, or infection). In this report, the FDA emphasized that the benefits and safety of T medications have not been established for the treatment of low T levels due to aging, even if a man's symptoms seem to be related to low T. In this paper, we reviewed the available evidence on the association between TRT and CV risk. In particular, data from randomized controlled studies and information derived from observational and pharmacoepidemiological investigations were scrutinized. The data meta-analyzed here do not support any causal role between TRT and adverse CV events. This is especially true when hypogonadism is properly diagnosed and replacement therapy is correctly performed. Elevated hematocrit represents the most common adverse event related to TRT. Hence, it is important to monitor hematocrit at regular intervals in T-treated subjects in order to avoid potentially serious adverse events.

Keyword

Hematocrit; Mortality; Myocardial infarction; Testosterone

MeSH Terms

Aging
Drug Therapy
Hematocrit
Humans
Hypogonadism
Hypothalamus
Male
Mortality
Myocardial Infarction
Testis
Testosterone*
United States Food and Drug Administration
Testosterone

Figure

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  Fig. 1 (A) Standardized Mean (95% Confidence Interval [Ci]) Differences In Hematocrit Levels (%) And (B) Mantel-haenzel (Mh) Odds Ratios (95% Ci) For Pathological Hematocrit Elevation (>52%) At Endpoint Between Subjects Treated With Testosterone Supplementation Or Placebo. These Data Were Obtained From A Previous metaanalysis [21].

• 

  Fig. 2 Odds ratios (95% confidence interval [CI]) for overall mortality (A) and acute myocardial inferction (B) in testosteroneuntreated vs. treated (tosterone replacement therapy) patients. These data were derived from available pharmacoepidemiological studies [35363740414243]. TS: testosterone supplementation.

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