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Reduced mortality with testosterone therapy unrelated to CVD risk factors in men with type 2 diabetes
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Testosterone therapy was shown to reduce mortality in men with type 2 diabetes regardless of improvements in cardiovascular disease risk factors, according to findings published in BJU International.
“[Previous testosterone research] showed clear benefits in sexual function, mood, depression, quality of life, physical performance, vitality, anemia and bone mineral density,” Geoffrey Hackett, MD, FRCPI, MRCGP, from the department of urology at the University Hospitals Birmingham NHS Foundation Trust in Birmingham, U.K., and the School of Health and Life Sciences at Aston University in Birmingham, U.K., and colleagues wrote. “Despite these positive outcomes, concern continues to exist regarding the cardiovascular safety of [testosterone therapy], especially from the U.S. FDA but not in Europe. In view of this, it is essential that the effects of [testosterone therapy] are extensively studied for outcomes and potential mechanism(s) leading to benefit.”
Hackett and colleagues assessed data on 857 U.K. men with type 2 diabetes collected between April 2007 and April 2009 for the BLAST RCT, a double-blind, randomized, placebo-controlled trial studying testosterone undecanoate (1,000 mg) and its effects on metabolism and sexual function. Participants were first divided according to testosterone level: a normal-testosterone group with total testosterone greater than 12 nmol/L and free testosterone greater than 0.25 nmol/L (n = 320; mean age, 64.2 years) and a low-testosterone group with levels below those cutoffs (n = 537; mean age, 63.2 years). The low-testosterone group was divided into participants who did not receive testosterone therapy (n = 362; mean age, 65.5 years) and those who did (n = 175; mean age, 58.3 years). The testosterone therapy group was further divided into those who continued the therapy (n = 78; mean age, 54 years) and those who discontinued therapy (n = 97; mean age, 61.8 years). Mortality was determined through general practice databases; and values for BMI, HbA1c, blood pressure, lipid levels and other CVD risk factors were collected from primary care records.
Mortality rates in the low-testosterone group that continued testosterone therapy (no deaths in mean follow-up of 3.6 years) and that discontinued testosterone therapy (6.19% in mean follow-up of 4 years; HR = 0.46; 95% CI, 0.17-1.07) were lower than those of the normal testosterone group (11.3%; HR = 0.59; 95% CI, 0.39-0.89) and the low-testosterone group without testosterone therapy (16.85% in mean follow-up of 3.6 years). The last group was used as reference during analysis.
Cox regression analysis showed no link between CVD risk factors and lower morality among those who received testosterone therapy. In addition, lower mortality was significantly linked to use of phosphodiesterase type 5 inhibitors by those who discontinued testosterone therapy (HR = 0.34; 95% CI, 0.12-0.94). After adjusting for age, weight and BMI, the researchers observed that reduced mortality was only found in men who weighed 93.8 kg or less.
“This study suggests that the reduction in all-cause mortality is more likely associated with increase in lean muscle mass and reduction in frailty rather than through conventional routinely measured diabetes risk factors,” Hackett told Endocrine Today. “The benefit was greatest in older men despite conventional practice warning that older men might be at increased risk from testosterone therapy.” – by Phil Neuffer
Disclosures: Hackett reports that he has received speaker honoraria from Bayer PLC. Please see the study for all other authors’ relevant financial disclosures.
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