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, M; Wu, Fc; Jones, Th; Jackson, G; Behre, Hm; Hackett, G; Martin Morales, A; Balercia, G; Dobs, As; Arver, St; Maggio, M; Cunningham, Gr; Isidori, Andrea; Quinton, R; Wheaton, Oa; Siami, Fs; Rosen, Rc. - In: INTERNATIONAL JOURNAL OF CLINICAL PRACTICE. - ISSN 1368-5031. - STAMPA. - 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)

ISIDORI, Andrea;
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.
2016
testosterone, hypogonadism, RHYME, cardiovascular, registry
01 Pubblicazione su rivista::01a Articolo in rivista
Testosterone treatment is not associated with increased risk of adverse cardiovascular events: results from the Registry of Hypogonadism in Men (RHYME) / Maggi, M; Wu, Fc; Jones, Th; Jackson, G; Behre, Hm; Hackett, G; Martin Morales, A; Balercia, G; Dobs, As; Arver, St; Maggio, M; Cunningham, Gr; Isidori, Andrea; Quinton, R; Wheaton, Oa; Siami, Fs; Rosen, Rc. - In: INTERNATIONAL JOURNAL OF CLINICAL PRACTICE. - ISSN 1368-5031. - STAMPA. - 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: https://hdl.handle.net/11573/902236
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