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• W1980217767 abstract "Two recent observational studies 1 Vigen R O'Donnell CI Barón AE et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013; 310: 1829-1836 Crossref PubMed Scopus (716) Google Scholar , 2 Finkle WD Greenland S Ridgeway GK et al. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One. 2014; 9: e85805 Crossref PubMed Scopus (534) Google Scholar and associated articles in the press 3 The New York Times Editorial BoardOverselling testosterone, dangerously. http://www.nytimes.com/2014/02/05/opinion/overselling-testosterone-dangerously.html?_r=0Date: Feb 4, 2014 Google Scholar , 4 La Puma John Don't ask your doctor about ‘Low T’. http://www.nytimes.com/2014/02/04/opinion/dont-ask-your-doctor-about-low-t.html?action=click&contentCollection=Opinion&module=RelatedCoverage&region=Marginalia&pgtype=articleDate: Feb 3, 2014 Google Scholar have raised concerns about the potential risks associated with prescription of testosterone to older men. However, these concerns are not new and are reminiscent of the debate about hormone replacement therapy and heart disease in women that raged before the Women's Health Initiative. However, if one thing was learnt from the Women's Health Initiative, it is that cumulative observational data cannot replace well-designed and undertaken randomised clinical trials. Observational studies such as those done by Vigen 1 Vigen R O'Donnell CI Barón AE et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013; 310: 1829-1836 Crossref PubMed Scopus (716) Google Scholar and Finkle 2 Finkle WD Greenland S Ridgeway GK et al. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One. 2014; 9: e85805 Crossref PubMed Scopus (534) Google Scholar and their collaborators should serve to galvanise both the public and medical communities to fund an appropriate clinical study to assess the risks and benefits of testosterone treatment in older men in an era when millions of men are using testosterone every day. The danger is that funding and regulatory agencies will overinterpret these types of observational studies and conclude that appropriate trials are unnecessary and unwarranted. This conclusion would do men's health a disservice. Testosterone and cardiovascular diseaseIn The Lancet Diabetes & Endocrinology, Stephanie T Page1 argues strongly for a large randomised controlled trial to assess the effects of testosterone treatment. In 2004, the Institute of Medicine2 concluded that such a trial was not justified because there was little evidence for benefit. In the past 10 years, however, prescriptions of testosterone have increased, particularly in the USA, even though evidence of benefit remains uncertain.3 Concerns have arisen about the cardiovascular safety of testosterone therapy. Full-Text PDF Testosterone and cardiovascular disease–Author's replyThe letters from T Hugh Jones and Schooling and Xu discuss continuing controversies in testosterone replacement therapy in men, further highlighting the need for a large randomised controlled trial to assess the risks for testosterone therapy in men. Although such a trial might not be definitive, the current knowledge deficit makes both clinicians and patients reliant on inconsistent expert opinion for treatment decision making, with experts citing selected, poorer quality data.1 Although the resource investment would be considerable, a large trial would likely reap large economic benefits, as recently shown by the Women's Health Initiative, from which the return on each US$1 invested is about $140. Full-Text PDF Testosterone and cardiovascular diseaseIt is important to distinguish between the use of testosterone as replacement therapy and testosterone being given without a diagnosis of hypogonadism to men with healthy testosterone status. Hypogonadism is defined as a clinical syndrome that comprises several symptoms, with or without signs, as well as biochemical evidence of testosterone deficiency. The recent studies critically discussed by Stephanie Page in her Comment1 provide no details about symptoms or pretreatment concentrations of testosterone, or even whether samples were collected before 1100 h on at least two separate occasions—concentrations can change between samples due to intercurrent illness, which can give a falsely low result. Full-Text PDF" @default.
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• W1980217767 title "Testosterone, cardiovascular disease, and mortality in men: living in the dark" @default.
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