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Lookup NU author(s): Professor Graham Jackson, Dr Richard Quinton
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AimsThe 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).MethodsThe 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 2-3years. Independent adjudication was performed on all mortalities and CV outcomes.ResultsOf 999 patients enrolled with clinically diagnosed HG, 750 (75%) initiated some form of TRT. Registry participants, including both treated and untreated patients, contributed 23900 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 100000 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.ConclusionsAge and prior CV history, not TRT use, were predictors of new-onset CV events in this multi-national, prospective hypogonadism registry.
Author(s): Maggi M, Wu FCW, Jones TH, Jackson G, Behre HM, Hackett G, Martin-Morales A, Balercia G, Dobs AS, Arver STE, Maggio M, Cunningham GR, Isidori AM, Quinton R, Wheaton OA, Siami FS, Rosen RC, RHYME Investigators
Publication type: Article
Publication status: Published
Journal: International Journal of Clinical Practice
Year: 2016
Volume: 70
Issue: 10
Pages: 843-852
Print publication date: 01/10/2016
Online publication date: 23/10/2016
Acceptance date: 22/08/2016
ISSN (print): 1368-5031
ISSN (electronic): 1742-1241
Publisher: Wiley-Blackwell Publishing Ltd.
URL: http://dx.doi.org/10.1111/ijcp.12876
DOI: 10.1111/ijcp.12876
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