TY - JOUR
T1 - Testosterone treatment is not associated with increased risk of adverse cardiovascular events
T2 - results from the Registry of Hypogonadism in Men (RHYME)
AU - the RHYME Investigators
AU - Maggi, Mario
AU - Wu, Frederick C.W.
AU - Jones, Thomas H.
AU - Jackson, Graham
AU - Behre, Hermann M.
AU - Hackett, Geoffrey
AU - Martin-Morales, Antonio
AU - Balercia, Giancarlo
AU - Dobs, Adrian S.
AU - Arver, Stefan T.E.
AU - Maggio, Marcello
AU - Cunningham, Glenn R.
AU - Isidori, Andrea M.
AU - Quinton, Richard
AU - Wheaton, Olivia A.
AU - Siami, Flora S.
AU - Rosen, Raymond C.
AU - Meuleman, E.
AU - Dohle, G.
AU - Wu, F.
AU - Porst, H.
AU - Jones, H.
AU - Lenzi, A.
AU - Bouloux, P. M.
AU - Morales, A. M.
AU - Stroberg, P.
AU - Cruz, N.
AU - Yassin, A.
AU - Reisman, C.
AU - Bassa, L.
AU - Pescatori, E.
AU - Martinez Salamanca, J. I.
AU - Romero Otero, J.
AU - Jockenhoevel, F.
AU - Debruyne, F.
N1 - Funding Information:
We gratefully acknowledge the outstanding contributions of RHYME investigators at the following sites: University of Florence, Italy, M. Maggi; University Hospital Halle, Germany, H. Behre; VU Medical Center, Netherlands, E. Meuleman; Erasmus MC Rotterdam, Netherlands, G. Dohle; Karolinska University Hospital, Sweden, S. Arver; University of Manchester, Central Manchester University Hospitals NHS Foundation Trust, UK, F. Wu; Private Practice of Urology/Andrology, Germany, H. Porst; Barnsley Hospital NHS Foundation Trust, UK, H. Jones; Royal Victoria Infirmary, UK, R. Quinton; Sapienza University of Rome, Italy, A. Lenzi; Royal Free Hampstead NHS, UK, P-M. Bouloux; Carlos Haya University Hospital, Spain, A.M. Morales; Holly Cottage Clinic, UK, G. Hackett; Urohälsan i Skövde, Sweden, P. Stroberg; University of Parma, Italy, M. Maggio; Hospital Virgen del Rocio, Spain, N. Cruz; Ospediali Riuniti di Ancona, Italy, G. Balercia; Segeberger Kliniken, Germany, A. Yassin; Amstelland Hospital, Netherlands, C. Reisman; Fundacio Puigvert, Spain, L. Bassa; Hesperia Hospital, Italy, E. Pescatori; Hospital Universitario Puerta de Hierro-Majadahonda, Spain, J.I. Martinez Salamanca; Hospital Universitario 12 Octubre, Spain, J. Romero Otero; Evangelisches Krankenhaus Herne, Germany, F. Jockenhoevel; Andros Mens Health Institutes, Netherlands, F. Debruyne. Valuable assistance was provided by Ms. Juli Martha, Madhavi Kamma, Blandyna Williams and other research staff at NERI. We acknowledge funding and technical support from Drs Farid Saad, Albert Radlmaier and Andreas Mattern at Bayer Healthcare.
Publisher Copyright:
© 2016 John Wiley & Sons Ltd
PY - 2016/10/1
Y1 - 2016/10/1
N2 - 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.
AB - 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.
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U2 - 10.1111/ijcp.12876
DO - 10.1111/ijcp.12876
M3 - Article
C2 - 27774779
AN - SCOPUS:84992152261
VL - 70
SP - 843
EP - 852
JO - Medical bookman and historian
JF - Medical bookman and historian
SN - 1368-5031
IS - 10
ER -