Research news

Survival and cardiovascular events in men treated with testosterone replacement therapy: an intention-to-treat observational cohort study. Wallis CJD, Lo K, Lee Y, et al. The Lancet Diabetes & Endocrinology. 2016; May 7

On the surface, testosterone therapy is a controversial treatment because previous studies investigating the effects of testosterone therapy have been conflicting, with some studies showing supposed harm and others showing significant benefit.

Here we present the results of a new study published in The Lancet Diabetes & Endocrinology on May 7 2016, which addressed some shortcomings in previous studies by analyzing effects based on duration of testosterone treatment.

KEY POINTS 

Effects of continuous long-term testosterone therapy (TTh) on anthropometric, endocrine and metabolic parameters for up to 10 years in 115 hypogonadal elderly men: real-life experience from an observational registry study.
Yassin AA, Nettleship J, Almehmadi Y, Salman M, Saad F. Andrologia 2016:Jan 14 [Epub ahead of print]

While it is well documented that testosterone levels decline in aging men, recent studies show that obesity and impaired general health can be more influential causes of testosterone deficiency than chronological age per se.

Serum testosterone, testosterone replacement therapy and all-cause mortality in men with type 2 diabetes: retrospective consideration of the impact of PDE5 inhibitors and statins.
Hackett G, Heald AH, Sinclair A, Jones PW, Strange RC, Ramachandran S. Int. J. Clin. Pract. 2016;70(3):244-253.

The prevalence of testosterone deficiency is higher in men with type 2 diabetes than among non-diabetic men, and testosterone deficiency is associated with increased mortality.

Type 2 diabetic men often have dyslipidemia and erectile dysfunction, and hence concomitant medications are widely used in these patients.

Effects of Testosterone Treatment in Older Men.
Snyder PJ, Bhasin S, Cunningham GR, et al. N. Engl. J. Med. 2016;374(7):611-624.

The double-blind randomized controlled trial (RCT) is accepted by medicine as the gold standard objective scientific methodology, and provides the highest strength of evidence for the effectiveness of a treatment. An accumulating body of evidence shows that treating hypogonadal men with testosterone therapy provides a number of wide-ranging benefits beyond mere relief of symptoms, including improvements in muscle mass, insulin sensitivity, fat mass (both total body fat and visceral fat), endothelial function, blood pressure, lipid profile and bone mineral density.

Insulin Resistance and Inflammation in Hypogonadotropic Hypogonadism and Their Reduction After Testosterone Replacement in Men With Type 2 Diabetes.
Dhindsa S, Ghanim H, Batra M, et al. Diabetes Care. 2016;39(1):82-91.

Testosterone deficiency – defined as low levels of total testosterone in the presence of symptoms - is common among men with obesity and type 2 diabetes, with a reported prevalence of 58% and 45%, respectively. However, even after adjusting for age and BMI, the prevalence of subnormal free testosterone levels (<5 ng/dL or 144 pmol/L) in men with type 2 diabetes is higher than in men without (45% versus 33%).

Hackett GI. Testosterone Replacement Therapy and Mortality in Older Men.
Drug Saf. 2016;39(2):117-130.

Despite a large prevalence of hypogonadism and increased testosterone prescribing over the past decade, population-based (BACH, Boston Area Community Health) and clinical-based studies (HIM, Health In Men) report that only 10-12% of hypogonadal patients (comprising 40-45% of studied populations) are receiving treatment.

Effects of Testosterone Administration for 3 Years on Subclinical Atherosclerosis Progression in Older Men With Low or Low-Normal Testosterone Levels: A Randomized Clinical Trial.
Basaria S, Harman SM, Travison TG, et al. JAMA. 2015;314(6):570-581.

Currently there are only a few high quality studies investigating the effects of testosterone therapy for a duration of 3 years and medical societies have long been urging for more long-term studies evaluating the safety and efficacy of testosterone therapy.

Critical Update of the 2010 Endocrine Society Clinical Practice Guidelines for Male Hypogonadism: A Systematic Analysis. Seftel AD, Kathrins M, Niederberger C. Mayo Clin Proc. 2015; 90(8): 1104-1115.

In 2010, the Endocrine Society published a Clinical Practice Guideline “Testosterone Therapy in Adult Men With Androgen Deficiency Syndromes”, which addressed important issues regarding the diagnosis and treatment of male hypogonadism.

STUDY: Sharma R, Oni OA, Gupta K, et al. Normalization of testosterone level is associated with reduced incidence of myocardial infarction and mortality in men. Eur Heart J. 2015;36(40):2706-2715.

The effect of testosterone replacement therapy on cardiovascular outcomes such as myocardial infarction (MI) and stroke are controversial and have been generating heated discussions among clinicians as well as researchers. This, coupled with biased media sensationalism blowing up the supposed “dangers” of testosterone therapy has created great confusion among suffering men, who could gain tremendous health benefits from testosterone therapy.

STUDY: Saad F, Yassin A, Doros G, Haider A. Effects of long-term treatment with testosterone on weight and waist size in 411 hypogonadal men with obesity classes I-III: observational data from two registry studies. Int J Obes (Lond). 2016;40(1):162-170.

Testosterone, historically believed to be important only for male reproduction and sexuality, has over the past decades transformed from niche hormone to multi-system player. A rapidly accumulating body of research is showing that testosterone is an important metabolic hormone with marked effects on energy metabolism and body composition.