Proven safety of testosterone replacement therapy in men with hypogonadism
Testosterone prescriptions for middle-aged and older men have increased significantly over the past few decades. Recently, researchers evaluated the cardiovascular safety of testosterone replacement therapy in adult men with hypogonadism. The incidence of adverse cardiac events did not increase with long-term use of testosterone gel.Researchers from Harvard Medical School, Boston University and cardiologists at the Cleveland Clinic Coordinating Center studied the adverse events of long-term use of testosterone gel among middle-aged and elderly men. The results of the study are published in The New England Journal of Medicine.
They analyzed data from 5246 men between the ages of 45 and 80 with a risk of cardiovascular disease or high risk of cardiovascular complications. These participants had symptoms of hypogonadism with fasting blood testosterone levels <300 ng/dL. Patients were divided into two groups: a group applying a 1.62% testosterone gel to maintain testosterone levels between 350 and 750 ng/dL and a group applying a testosterone-free gel. After applying the gel for an average of two years, the researchers analyzed deaths from cardiovascular disease, non-fatal myocardial infarction, non-fatal stroke, and coronary revascularization. The mean duration of follow-up was 33 months.
There were no significant differences between groups in the incidence of major cardiovascular complications: 7.3% in the testosterone group and 7.0% in the placebo group. A higher incidence of atrial fibrillation, acute kidney injury and pulmonary embolism was observed in the testosterone group.