M Maggi, FC Wu, TH Jones, G Jackson, HM Behre, G Hackett, A Martin-Morales, G Balercia, AS Dobs, ST Arver, M Maggio, GR Cunningham, AM Isidori, R Quinton, OA Wheaton, FS Siami, RC Rosen, E Meuleman, G Dohle, F Wu, H Porst, H Jones, A Lenzi, PM Bouloux, AM Morales, P Stroberg, N Cruz, A Yassin, C Reisman, L Bassa, E Pescatori, JI Martinez Salamanca, J Romero Otero, F Jockenhoevel and F Debruyne,
International journal of clinical practice, Oct 2016
The aim of this study was to assess cardiovascular (CV) safety of testosterone replacement therapy (TRT) in a large, diverse cohort of European men with hypogonadism (HG).The Registry of Hypogonadism in Men (RHYME) was designed as a multi-national, longitudinal disease registry of men diagnosed with hypogonadism (HG) at 25 clinical sites in six European countries. Data collection included a complete medical history, physical examination, blood sampling and patient questionnaires at multiple study visits over 2-3 years. Independent adjudication was performed on all mortalities and CV outcomes.Of 999 patients enrolled with clinically diagnosed HG, 750 (75%) initiated some form of TRT. Registry participants, including both treated and untreated patients, contributed 23 900 person-months (99.6% of the targeted) follow-up time. A total of 55 reported CV events occurred in 41 patients. Overall, five patients died of CV-related causes (3 on TRT, 2 untreated) and none of the deaths were adjudicated as treatment-related. The overall CV incidence rate was 1522 per 100 000 person-years. CV event rates for men receiving TRT were not statistically different from untreated men (P=.70). Regardless of treatment assignment, CV event rates were higher in older men and in those with increased CV risk factors or a prior history of CV events.Age and prior CV history, not TRT use, were predictors of new-onset CV events in this multi-national, prospective hypogonadism registry.