LONDON — Testosterone replacement therapy does not appear to increase the risk for cardiovascular disease or thromboembolic events in middle-aged men, but it does increase the risk for obstructive sleep apnea, results from a large cohort study suggest.
In fact, the risk for a cardiovascular event was lower in men taking supplemental testosterone than in those who were not, said lead investigator Julian Hanske, MD, from Ruhr University Bochum in Herne, Germany, who collaborated on the study during a fellowship at Brigham & Women's Hospital in Boston.
But physicians should know whether a patient suffers from obstructive sleep apnea before prescribing testosterone, Dr Hanske said here at the European Association of Urology 2017 Congress.
Cohort studies of the cardiovascular and thromboembolic consequences of supplemental testosterone have generally relied on sources such as the Surveillance, Epidemiology, and End Results Medicare database, which is limited to an older population, he told Medscape Medical News.
To get a better handle on the relative risks associated with testosterone replacement therapy in a younger population, Dr Hanske and his team searched the TRICARE American military insurance database, which covers all retired and active-duty military personnel and their dependents.
They looked for men 40 to 65 years of age treated for low levels of testosterone. Patients were excluded if they had a history of heart disease, thromboembolism, prostate cancer, or obstructive sleep apnea.
For the final cohort, 3422 men who took testosterone were matched with 3422 control subjects who did not by year of birth, then by date of first testosterone prescription, and then by race and baseline comorbidities.
The study outcomes were event-free survival and absolute risk for cardiovascular disease, thromboembolism or obstructive sleep apnea.
Cardiovascular event-free survival was significantly better in the testosterone group than in the control group (P = .0085), and risk for coronary artery disease was lower in the testosterone group (P = .0082).
There was no difference in thromboembolic event-free survival between the testosterone and control groups (P = .0998).
However, the 2-year absolute risk for obstructive sleep apnea was significantly higher in the testosterone group than in the control group (16.5% vs 12.7%; P = .0001).
These findings are reassuring, said session comoderator Raanan Tal, MD, head of the male infertility program at Rambam Medical Center in Haifa, Israel.
"We have so many fears of testosterone replacement therapy, and actually what they showed is that so many beliefs that we have cannot be supported," he told Medscape Medical News.
"The fact that you don't have an increase in cardiovascular events or thrombotic events is an important message — more important than the risk of increased obstructive sleep apnea," he explained.
But the other comoderator said he thinks the findings would be more compelling if the investigators had used propensity-score matching or a similar statistical method to ensure a close case–control match.
"Age is a risk factor," Andrea Salonia, MD, from the Vita-Salute San Raffaele University in Milan, pointed out. "The younger the patient, the lower the probability of having difficulties sleeping at night, and they did not adjust for that specific issue, or at least they did not find any kind of difference according to this specific variable."
"At the same time, the number of patients they considered was amazing, and it is probably one of the most important studies in terms of the huge cohort they selected," Dr Salonia told Medscape Medical News.
Dr Hanske, Dr Tal, and Dr Salonia have disclosed no relevant financial relationships.
European Association of Urology (EAU) 2017 Congress: Abstract 256. Presented March 25, 2017.
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Cite this: Testosterone Tie to Cardiovascular Disease Loosened - Medscape - Mar 27, 2017.
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