title: Testosterone treatment is not associated with increased risk of adverse cardiovascular events: results from the Registry of Hypogonadism in Men (RHYME).
abstract: OBJECTIVE
  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.
authors: Department of Experimental and Clinical Biomedical Sciences, Sexual Medicine and Andrology Unit, University of Florence, Florence, Italy.
authors: Mario
authors: M
authors: Maggi
authors: Andrology Research Unit, Centre for Endocrinology and Diabetes, Central Manchester University Hospitals NHS Foundation Trust, University of Manchester, Manchester, UK.
authors: Frederick C W
authors: FC
authors: Wu
authors: Department of Diabetes and Endocrinology, Barnsley Hospital NHS Foundation Trust, Barnsley, UK.
authors: Thomas H
authors: TH
authors: Jones
authors: Department of Cardiology, London Bridge Hospital, London, UK.
authors: Graham
authors: G
authors: Jackson
authors: Center for Reproductive Medicine and Andrology, Martin Luther University Halle-Wittenberg, Halle, Germany.
authors: Hermann M
authors: HM
authors: Behre
authors: Holly Cottage Clinic, Lichfield, UK.
authors: Geoffrey
authors: G
authors: Hackett
authors: Carlos Haya University Hospital, Malaga, Spain.
authors: Antonio
authors: A
authors: Martin-Morales
authors: Ospedali Riuniti - Ancona, Ancona, Italy.
authors: Giancarlo
authors: G
authors: Balercia
authors: Division of Endocrinology, Diabetes and Metabolism, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors: Adrian S
authors: AS
authors: Dobs
authors: Karolinska University Hospital, Stockholm, Sweden.
authors: Stefan T E
authors: ST
authors: Arver
authors: University of Parma, Parma, Italy.
authors: Marcello
authors: M
authors: Maggio
authors: Department of Endocrinology, Baylor College of Medicine, Houston, TX, USA.
authors: Glenn R
authors: GR
authors: Cunningham
authors: Sapienza University of Rome, Rome, Italy.
authors: Andrea M
authors: AM
authors: Isidori
authors: Institute of Genetic Medicine, University of Newcastle-on-Tyne, Newcastle-on-Tyne, UK.
authors: Richard
authors: R
authors: Quinton
authors: New England Research Institutes, Inc., Watertown, MA, USA.
authors: Olivia A
authors: OA
authors: Wheaton
authors: New England Research Institutes, Inc., Watertown, MA, USA.
authors: Flora S
authors: FS
authors: Siami
authors: New England Research Institutes, Inc., Watertown, MA, USA. rrosen@neriscience.com.
authors: Raymond C
authors: RC
authors: Rosen
mesh_terms: D000328:Adult; D000368:Aged; D000728:Androgens / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000139:chemically induced*; D020249:Hormone Replacement Therapy / Q000009:adverse effects*; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D012042:Registries; D012307:Risk Factors; D013739:Testosterone / Q000627:therapeutic use*
chemical_list: D000728:Androgens; D013739:Testosterone