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Testosterone therapy could benefit CV health, contrary to several studies
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No convincing evidence exists to link increased cardiovascular risks with testosterone therapy, according to a review published in Mayo Clinic Proceedings.
Rather, evidence from research conducted around the world for several decades suggests a beneficial relationship between the hormone therapy and CV health, researchers found.
“Testosterone has been presented as if there were a debate about whether it is good or evil. Rather, it is a long-accepted medical treatment for a medical condition recognized for centuries. Abraham Morgentaler, MD, FACS, of the division of urology at Beth Israel Deaconess Medical Center and director of Men’s Health Boston, said in a news release. “Our intention was to cut through the confusion of loudly expressed opinions on nonscientific issues — such as pharmaceutical advertising, antiaging claims, and the importance of sexuality in older men — to provide the most comprehensive review to date of the literature on testosterone and cardiovascular risk.”
Abraham Morgentaler
Morgentaler and colleagues from various institutions, with expertise spanning urology, endocrinology, family medicine and steroid research, reviewed the literature on testosterone and CV risks based on a MEDLINE search of articles published between 1940 and 2014. The researchers used testosterone, androgens, human, male, cardiovascular, stroke, cerebrovascular accident, myocardial infarction, heart attack, death and mortality as keywords.
Two recent studies that raised new concerns around CV risks with testosterone therapy were included.
The investigators evaluated the weight and direction of evidence, then assigned level of evidence (LOE).
Four articles pointed to elevated CV risks with testosterone prescriptions; two were retrospective analyses with “serious methodological limitations,” one a placebo-controlled trial with few major adverse CV events and one a meta-analysis with questionable studies and events, according to the researchers.
Several dozen articles assessing the associations between testosterone and heart-related issues, including coronary artery disease, ischemic stroke, cholesterol levels, angina and heart failure described a beneficial effect of normal testosterone levels on CV risks and mortality. Mortality and incident CAD were inversely associated with serum testosterone (LOE IIa) along with CAD severity (LOE IIa). Testosterone therapy was associated with reduced obesity, fat mass and waist circumference (LOE Ib) and improved glycemic control (LOE IIa).
Further, several randomized controlled trials that involved men with CAD or heart failure reported improved health with testosterone therapy vs. placebo. In the largest meta-analysis to date, no CV risk increase was seen among men on testosterone therapy, and those with metabolic disease demonstrated reduced CV risk.
Two retrospective studies showed a reduced mortality rate with testosterone therapy, and two observational studies found twice as many deaths among men with low testosterone who did not receive testosterone therapy than among those who did receive treatment.
Increased sex drive, energy and bone mineral density are among the benefits demonstrated in other studies. The researchers highlight “promising new data” suggesting testosterone therapy improved insulin sensitivity and reduced blood glucose and HbA1c levels in men with type 2 diabetes or obesity.
Morgentaler said in the release that “trumpeting studies providing remarkably weak evidence of risk, and ignoring a substantial literature with reassuring or beneficial results” have confused the assessment of testosterone.
“Public health may be harmed not only by inadequate appreciation of an actual risk, but also by the failure to offer beneficial treatment for a medical condition because of false claims of risk concerns,” the researchers wrote.
Disclosure: Morgentaler reports various financial ties with AbbVie, Antares Pharma, Auxilium Pharmaceuticals, Bayer, Clarus Therapeutics, Eli Lilly and Company, Endo Pharmaceuticals, Lipocine, MHB Labs, Pfizer and TesoRx. Other researchers report relationships with AbbVie, Auxilium Pharmaceuticals, Endo Pharmaceuticals, Forest Laboratories, Lipocine and Repros Pharmaceuticals Inc.
Perspective
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Paresh Dandona, MD, PhD
This review by Morgentaler and colleagues successfully undoes the myth about testosterone created by bad articles and will reverse a lot of the damage that has been done.
The investigators critically analyzed published studies, looking at scientific merit and statistical methodology employed. In at least one paper, the methodology was not appropriate and positive results for testosterone, through manipulations, appeared negative.
Practicing clinicians can feel safer using testosterone as replacement therapy in patients objectively shown to be deficient, with a precise and accurate diagnosis.
The researchers call for prospective, randomized studies to determine the safety, or otherwise, of testosterone. In all probability, when these studies are conducted, testosterone will turn out to benefit men who don’t have it — just like estradiol turned out to benefit postmenopausal women after being castigated earlier as leading to increased cardiovascular events.
Conditions hitherto unrecognized by the medical community-at-large that are associated with large numbers of patients having low testosterone will also then gain consideration.
The populations with type 2 diabetes and obesity constitute the largest number of patients with low testosterone today. These patients need help, and we need to devise strategies to treat them.
First, we need to recognize that testosterone treatment is not unsafe, secondly, that testosterone treatment is safe, and thereafter to use testosterone in appropriate settings, in appropriate patients who are appropriately diagnosed.
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