Aims: 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). Methods: 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. Results: 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. Conclusions: Age and prior CV history, not TRT use, were predictors of new-onset CV events in this multi-national, prospective hypogonadism registry.

Testosterone treatment is not associated with increased risk of adverse cardiovascular events: results from the Registry of Hypogonadism in Men (RHYME) / Maggi, Mario; Wu, Frederick C.W.; Jones, Thomas H.; Jackson, Graham; Behre, Hermann M.; Hackett, Geoffrey; Martin-Morales, Antonio; Balercia, Giancarlo; Dobs, Adrian S.; Arver, Stefan T.E.; Maggio, Marcello; Cunningham, Glenn R.; Isidori, Andrea M.; Quinton, Richard; Wheaton, Olivia A.; Siami, Flora S.; Rosen, Raymond C; Meuleman, E.; Dohle, G.; Wu, F.; Porst, H.; Jones, H.; Lenzi, A.; Bouloux, P.-M.; Morales, A.M.; Stroberg, P.; Cruz, N.; Yassin, A.; Reisman, C.; Bassa, L.; Pescatori, E.; Martinez Salamanca, J.I.; Romero Otero, J.; Jockenhoevel, F.; Debruyne, F.. - In: INTERNATIONAL JOURNAL OF CLINICAL PRACTICE. - ISSN 1368-5031. - 70:10(2016), pp. 843-852. [10.1111/ijcp.12876]

Testosterone treatment is not associated with increased risk of adverse cardiovascular events: results from the Registry of Hypogonadism in Men (RHYME)

MAGGIO, Marcello Giuseppe;
2016

Abstract

Aims: 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). Methods: 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. Results: 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. Conclusions: Age and prior CV history, not TRT use, were predictors of new-onset CV events in this multi-national, prospective hypogonadism registry.
Testosterone treatment is not associated with increased risk of adverse cardiovascular events: results from the Registry of Hypogonadism in Men (RHYME) / Maggi, Mario; Wu, Frederick C.W.; Jones, Thomas H.; Jackson, Graham; Behre, Hermann M.; Hackett, Geoffrey; Martin-Morales, Antonio; Balercia, Giancarlo; Dobs, Adrian S.; Arver, Stefan T.E.; Maggio, Marcello; Cunningham, Glenn R.; Isidori, Andrea M.; Quinton, Richard; Wheaton, Olivia A.; Siami, Flora S.; Rosen, Raymond C; Meuleman, E.; Dohle, G.; Wu, F.; Porst, H.; Jones, H.; Lenzi, A.; Bouloux, P.-M.; Morales, A.M.; Stroberg, P.; Cruz, N.; Yassin, A.; Reisman, C.; Bassa, L.; Pescatori, E.; Martinez Salamanca, J.I.; Romero Otero, J.; Jockenhoevel, F.; Debruyne, F.. - In: INTERNATIONAL JOURNAL OF CLINICAL PRACTICE. - ISSN 1368-5031. - 70:10(2016), pp. 843-852. [10.1111/ijcp.12876]
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11381/2818350
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