Testosterone replacement therapy in hypogonadal male patients with hypogonadism and heart failure: a meta-analysis of randomized controlled studies

INTRODUCTION: The recently published guidelines of the European Academy of Andrology (EAA) recommended not to prescribe testosterone replacement therapy (TRT) in male patients with hypotestosteronemia and severe heart failure (HF) [New York Hearth Association (NYHA) class III and IV] since the risk in these patients has not been formally documented. Therefore, the aim of this study was to systematically evaluate the risk of TRT on the cardiac function and angina, in male patients with hypotestosteronemia and HF or coronary heart disease. EVIDENCE ACQUISITION: Randomized controlled trials (RCTs) on male patients with hypotestosteronemia and chronic HF (ejection fraction <40%) or stable angina documenting the effect of TRT on NYHA class, left ventricular ejection fraction (LVE F), adverse events, ST depression and other indexes of cardiovascular function. EVIDENCE SYNTHESIS: Seven articles were included, for a total of 140 participants with HF (71 on TRT and 69 on placebo or no treatment). Included patients were of NYHA class II and III. TRT had no effect on death and rehospitalization rates of patients with HF and significantly delayed the time to ischemia in patients with chronic angina. TRT had no effect on the NYHA class, the LVEF, and on the Minnesota Living with Heart Failure questionnaire. Although a significant increase of oxygen consumption was found in the TRT group, no improvement to the physical exercise tolerance tests was observed. TRT showed no effect on systolic nor diastolic blood pressure, but it significantly ameliorated the heart rate. It significantly decreased the insulin serum levels and the HOMA index. CONCLUSIONS: These results suggest the safety of TRT, in patients with hypotestosteronemia and severe HF (class NYHA II and III). Although deriving from a limited number of studies, these data could prompt to perform other RCTs on the effects of TRT in patients with hypotestosteronemia and severe HFrEF (NYHA class III).