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Wider use of testosterone therapy is not risk free

As one of those whose passions were aroused by testosterone replacement therapy (TRT) in men, I am delighted that Clinical Pharmacist has provided Geoff Hackett with a platform to clarify the current clinical position (Clinical Pharmacist 2017;9:195). Hackett rightly points out that we should have no truck with those who have “preconceived views on testosterone and interpret studies based on these preconceptions”.

Indeed, with the feel of his erudite hand firmly on my collar, I confess that my own comments on this matter which used the inflammatory term “male menopause” (The Pharmaceutical Journal 2017;298;100) did not have the benefit of more recent studies quoted in this excellent article and I apologise if I appeared trite, cynical or indifferent. It is good to have a dispassionate, objective review of this subject focused on the facts.

My initial concerns about safety and efficacy of TRT were based on a letter from my colleague Sid Dajani (The Pharmaceutical Journal 2016;297:364) who appeared to me to be promoting the medicalisation of the ageing male population — a population I am now part of and hope to be for some time — by screening for low testosterone levels and, where identified, treating. In fact, I believe they should first stop smoking, reduce their drinking, take more exercise and relax. These steps would reduce their risk of cardiovascular disease and diabetes yet, I admit, they may not enjoy an early morning erection. Dajani was defiant about my concerns (The Pharmaceutical Journal 2017;298:235) over efficacy and I now know that I was wrong. There is good evidence for efficacy across a number of clear clinical outcomes. Hackett has convinced me of this.

But what about safety? Hackett attempts to convince me (and it may be just my stupidity so forgive me) but he seems to find studies that disagree with his case methodologically flawed whereas supportive studies do not attract such censure. I know that by saying that I risk being called out as one of the “biased evangelical healthcare professionals dispensing their own standards of social justice”. I hope not.

For example, he severely criticises the methodology in a paper published by Vigen et al[1]. The conclusion of this paper states: Long-term exposure to testosterone replacement therapy was associated with reduced risks of mortality, cardiovascular events, and prostate cancer. However, testosterone replacement therapy increased the risk of mortality and cardiovascular events with short durations of therapy. In view of the limitations of observational data and the potential for selection bias, these results warrant confirmation in a randomised trial.”

I seem to understand what these authors are saying as; if the treatment does not kill you in the first few months then it might save your life. Very Nietzsche indeed.

I bow to Hackett’s expertise on methodology. However, he also quotes a paper by Wallis et al[2] and without any criticisms of its methodology, quotes this study as supporting a decreased risk in all-cause mortality from TRT making no reference to the authors’ safety concerns: “Use of testosterone therapy in this cohort of veterans with significant medical comorbidities was associated with increased risk of mortality, myocardial infarction, or ischaemic stroke. These findings were not modified by the presence of coronary artery disease. Future studies including randomised controlled trials are needed to properly characterise the potential risks of testosterone therapy in men with comorbidities.”

This is clearly a complex clinical area. I would respectfully suggest that, accepting that TRT has an important clinical role when in the hands of experts such as Hackett, wider use of TRT is not a risk free-panacea for the ills of the ageing baby boomers.

Terry Maguire

Belfast

Citation: Clinical Pharmacist DOI: 10.1211/CP.2017.20203367

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