Risk factors associated with cardiovascular events during testosterone administration in older men with mobility limitation

Shehzad Basaria, Maithili N. Davda, Thomas G. Travison, Jagadish Ulloor, Ravinder Singh, Shalender Bhasin

Research output: Contribution to journalArticle

46 Scopus citations

Abstract

Background.Testosterone in Older Men with Mobility Limitations Trial found an increased incidence of cardiovascular events in men randomized to testosterone, resulting in enrollment cessation by trial's Data and Safety Monitoring Board. We evaluated changes in gonadal hormones and markers of inflammation and coagulation to elucidate risk factors associated with cardiovascular events.Methods.Men aged 65 years or more, with mobility limitation, total testosterone 100-350 ng/dL, or free testosterone less than 50 pg/mL, were randomized to placebo or 10 g testosterone gel daily for 6 months. Changes in total and free testosterone, estradiol and estrone, C-reactive protein, interleukin 6, fibrinogen, plasminogen activator inhibitor-1, and pro-brain naturetic peptide were compared between groups and within the testosterone group between subjects who experienced cardiovascular events and those who did not.Results.Of 209 men randomized (mean age 74 years), gonadal hormones and biomarkers were available in 179 men. Baseline body mass index, gonadal hormones, lipids, Framingham risk scores, and other biomarkers were similar in the two treatment groups. Within the testosterone group, the 6-month increase in free testosterone was significantly greater in men who experienced cardiovascular events than in those who did not [mean (95% confidence interval), 10.6 (4.6-16.7) vs 5.2 (3.0-7.5) ng/dL, p =. 05]. In multivariable logistic regression analysis, the change in the serum levels of free testosterone was associated with cardiovascular events.Conclusion.Mobility-limited older men who experienced cardiovascular events had greater increases in serum free testosterone levels than those who did not.

Original languageEnglish (US)
Pages (from-to)153-160
Number of pages8
JournalJournals of Gerontology - Series A Biological Sciences and Medical Sciences
Volume68
Issue number2
DOIs
StatePublished - Feb 2013

Keywords

  • Cardiovascular disease
  • Mobility limitation
  • Older men
  • Testosterone

ASJC Scopus subject areas

  • Aging
  • Geriatrics and Gerontology

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