05 Feb Testosterone Replacement Therapy Update
Testosterone replacement therapy (TRT) is a growing and important male health factor that is subject to considerable confusion in social media and medical publications alike. The best way to sort through the noise is to focus attention on peer reviewed research such as the one published just this last month in the journal Aging Male.
Japanese researchers were studying the effective of TRT on a case controlled, cohort of 36 hypogonadal males on blood pressure, fasting blood sugar and HbA1C (diabetes risk), total cholesterol, triglyceride (TG), high density lipoprotein-Chol values, and prostate specific antigen (PSA) level at baseline, 1-, 3-, and 5-years from initial intervention.
Researchers found that 5 years of TRT optimized all of these risk factors without increasing PSA a biomarker of prostate cancer. This is an important study since many patient’s and some doctors believe, incorrectly, that TRT can increase the risk of prostate cancer. This study supports the consensus that TRT is safe for the prostate, provided that the patient is screened for prostate cancer BEFORE starting TRT.
The Japanese study focussed on the individual biomarkers that are associated with LOWER risk of cardiovascular disease (CVD) in men taking TRT and deepen our understanding of the existing research documenting the benefits of TRT.
Other recent studies focus on the risk of blood clots in the leg (deep vein thrombosis) and the lung (pulmonary embolism) and once again, the myth that TRT increases the risk was refuted. This study did not detect a significant association between testosterone replacement therapy and risk of DVT/PE in adult men with low sTT who were at low to moderate baseline risk of DVT/PE.
In fact there is significant and growing evidence that TRT LOWERS mortality risk in men, including the veterans administration study of 83,000 men that concluded: [in] men with low testosterone levels, testosterone treatment was associated with decreased mortality compared with no testosterone treatment.
Testosterone replacement therapy is safe, effective and reduces the risk of heart disease, diabetes, obesity and death in hypogonadal males when treated by a qualified and experienced physician with special focus on pre treatment screening of contraindications, particularly looking for occult prostate cancer before initiation of therapy.
Dr. R. Knipping BSc MD CCFP FAARM ABAARM
Aging Male. 2019 Jan 16:1-6. doi: 10.1080/13685538.2018.1550060. [Epub ahead of print]
The five-year effects of testosterone replacement therapy on lipid profile and glucose tolerance among hypogonadal men in Japan: a case control study.
This study investigated the efficacy of 5-year testosterone replacement therapy (TRT) on lipid profile and glucose tolerance in Japanese hypogonadal men.
Fourteen patients, who received continuous TRT for 5 years, and 22 controls with 5-year observations were enrolled. The patients in the TRT group had received intramuscular injections of testosterone enanthate (250 mg) every month for 5 years. We collected the following data: blood pressure, fasting blood sugar (FBS), hemoglobin A1c (HbA1c), total cholesterol, triglyceride (TG), high density lipoprotein-Chol values, and prostate specific antigen (PSA) level at baseline, 1-, 3-, and 5-years from initial intervention. These data were compared between the two groups.
There were no statistically significant differences in any other baseline characteristic, excluding SBP, between the two groups. FBS was significantly improved at 3- and 5-year visits in the TRT group compared to the control group. Furthermore, the HbA1c level and TG value demonstrated a significant decrease at 1-, 3-, and 5-years in the TRT group. However, no significant difference in changes to PSA levels from baseline in both groups was observed.
Five-year TRT could improve FBS, HbA1c, and TG levels among Japanese hypogonadal men with no significant increase in PSA.
Testosterone replacement therapy; glucose tolerance; hypogonadism; lipid profile; long-term
Chest. 2016 Sep;150(3):563-71. doi: 10.1016/j.chest.2016.05.007. Epub 2016 May 12.
Association Between Testosterone Replacement Therapy and the Incidence of DVT and Pulmonary Embolism: A Retrospective Cohort Study of the Veterans Administration Database.
Testosterone replacement therapy (TRT) prescriptions have increased several-fold in the last decade. There have been concerns regarding a possible increased incidence of DVT and pulmonary embolism (PE) with TRT. Few data support the association between TRT and DVT/PE. We evaluated the incidence of DVT and PE in men who were prescribed TRT for low serum total testosterone (sTT) levels.
This is a retrospective cohort study, conducted using data obtained from the Veterans Affairs Informatics and Computing Infrastructure. We compared the incidence of DVT/PE between those who received TRT and subsequently had normal on-treatment sTT levels (Gp1), those who received TRT but continued to have low on-treatment sTT (Gp2), and those who did not receive TRT (Gp3). Those with prior history of DVT/PE, cancer, hypercoagulable state, and chronic anticoagulation were excluded.
The final cohort consisted of 71,407 subjects with low baseline sTT. Of these, 10,854 did not receive TRT (Gp3) and 60,553 received TRT. Of those who received TRT, 38,362 achieved normal sTT (Gp1) while 22,191 continued to have low sTT (Gp2). The incidence of DVT/PE was 0.5%, 0.4%, and 0.4% in Gp1, Gp2, and Gp3, respectively. Univariate, multivariate, and stabilized inverse probability of treatment weights analyses showed no statistically significant difference in DVT/PE-free survival between the various groups.
This study did not detect a significant association between testosterone replacement therapy and risk of DVT/PE in adult men with low sTT who were at low to moderate baseline risk of DVT/PE.
Copyright © 2016 American College of Chest Physicians. All rights reserved.
J Clin Endocrinol Metab. 2012 Jun;97(6):2050-8. doi: 10.1210/jc.2011-2591. Epub 2012 Apr 11.
Testosterone treatment and mortality in men with low testosterone levels.
Low testosterone levels in men have been associated with increased mortality. However, the influence of testosterone treatment on mortality in men with low testosterone levels is not known.
The objective of the study was to examine the association between testosterone treatment and mortality in men with low testosterone levels.
This was an observational study of mortality in testosterone-treated compared with untreated men, assessed with time-varying, adjusted Cox proportional hazards regression models. Effect modification by age, diabetes, and coronary heart disease was tested a priori.
The study was conducted with a clinical database that included seven Northwest Veterans Affairs medical centers.
Patients included a cohort of 1031 male veterans, aged older than 40 yr, with low total testosterone [≤250 ng/dl (8.7 nmol/liter)] and no history of prostate cancer, assessed between January 2001 and December 2002 and followed up through the end of 2005.
MAIN OUTCOME MEASURE:
Total mortality in testosterone-treated compared with untreated men was measured.
Testosterone treatment was initiated in 398 men (39%) during routine clinical care. The mortality in testosterone-treated men was 10.3% compared with 20.7% in untreated men (P<0.0001) with a mortality rate of 3.4 deaths per 100 person-years for testosterone-treated men and 5.7 deaths per 100 person-years in men not treated with testosterone. After multivariable adjustment including age, body mass index, testosterone level, medical morbidity, diabetes, and coronary heart disease, testosterone treatment was associated with decreased risk of death (hazard ratio 0.61; 95% confidence interval 0.42-0.88; P = 0.008). No significant effect modification was found by age, diabetes, or coronary heart disease.
In an observational cohort of men with low testosterone levels, testosterone treatment was associated with decreased mortality compared with no testosterone treatment. These results should be interpreted cautiously because residual confounding may still be a source of bias. Large, randomized clinical trials are needed to better characterize the health effects of testosterone treatment in older men with low testosterone levels.