The Controversy of Testosterone Replacement.

In November 2013 and January 2014, two studies raised concerns regarding increased cardiovascular (CV) risks in men receiving testosterone (T) therapy, resulting in significant public attention and concerns about the safety of T therapy. However, a review of the literature, including the mentioned studies, reveals that there is no convincing evidence to support the claim that testosterone therapy is associated with increased CV risks.

The two studies that raised concerns have been criticized for their methodological limitations. In contrast, numerous studies have reported a beneficial effect of normal testosterone levels on CV risks and mortality. These studies have shown that:

Mortality and incident coronary artery disease are inversely associated with serum testosterone concentrations (Level of Evidence IIa).

Severity of coronary artery disease is inversely associated with serum testosterone concentrations (Level of Evidence IIa).

Testosterone therapy is associated with reduced obesity, fat mass, and waist circumference (Level of Evidence Ib).

Testosterone therapy improves glycemic control (Level of Evidence IIa).

Mortality was reduced with testosterone therapy in two retrospective studies.

Several randomized controlled trials (RCTs) involving men with coronary artery disease or heart failure have reported improved function in those receiving testosterone compared to placebo. The largest meta-analysis to date, which included 75 placebo-controlled studies, found no increase in CV risks in men receiving testosterone therapy and reduced CV risk among those with metabolic disease.

In summary, there is no strong evidence to support the notion that testosterone therapy is associated with increased cardiovascular risks. Instead, numerous studies point to a beneficial relationship between normal testosterone levels and cardiovascular health. However, further research through large, long-term, placebo-controlled randomized clinical trials is necessary to provide definitive conclusions about the relationship between testosterone therapy and cardiovascular risks.

Morgentaler, A., et.al. Mayo Clinic Proceedings, 2015-02-01, Volume 90, Issue 2, Pages 224-251.

 It seems so strange that despite there being no credible evidence of cardiac compromise with testosterone replacement that the FDA has suggested potential detriment.  Hence why we find it so important to practice evidence based medicine. 

Jason & Rita.