Testosterone use in older men is increasing, but its long-term effects on progression of atherosclerosis are unknown.
To determine the effect of testosterone administration on subclinical atherosclerosis progression in older men with low or low-normal testosterone levels.
Testosterone's Effects on Atherosclerosis Progression in Aging Men (TEAAM) was a placebo-controlled, double-blind, parallel-group randomized trial involving 308 men 60 years or older with low or low-normal testosterone levels (100-400 ng/dL; free testosterone
One hundred fifty-six participants were randomized to receive 7 5 g of 1% testosterone and 152 were randomized to receive placebo gel packets daily for 3 years The dose was adjusted to achieve testosterone levels between 500 and 900 ng/dL
Coprimary outcomes included common carotid artery intima-media thickness and coronary artery calcium; secondary outcomes included sexual function and health-related quality of life
Baseline characteristics were similar between groups: patients were a mean age of 67 6 years; 42% had hypertension; 15%, diabetes; 15%, cardiovascular disease; and 27%, obesity The rate of change in intima-media thickness was 0 010 mm/year in the placebo group and 0 012 mm/year in the testosterone group (mean difference adjusted for age and trial site, 0 0002 mm/year; 95% CI, -0 003 to 0 003, P = 89) The rate of change in the coronary artery calcium score was 41 4 Agatston units/year in the placebo group and 31 4 Agatston units/year in the testosterone group (adjusted mean difference, -10 8 Agatston units/year; 95% CI, -45 7 to 24 2; P = 54) Changes in intima-media thickness or calcium scores were not associated with change in testosterone levels among individuals assigned to receive testosterone Sexual desire, erectile function, overall sexual function scores, partner intimacy, and health-related quality of life did not differ significantly between groups Hematocrit and prostate-specific antigen levels increased more in testosterone group
Among older men with low or low-normal testosterone levels, testosterone administration for 3 years vs placebo did not result in a significant difference in the rates of change in either common carotid artery intima-media thickness or coronary artery calcium nor did it improve overall sexual function or health-related quality of life Because this trial was only powered to evaluate atherosclerosis progression, these findings should not be interpreted as establishing cardiovascular safety of testosterone use in older men
clinicaltrials gov Identifier: NCT00287586
JAMA 2015 Aug 11 [Epub]
Shehzad Basaria, S Mitchell Harman, Thomas G Travison, Howard Hodis, Panayiotis Tsitouras, Matthew Budoff, Karol M Pencina, Joseph Vita, Connie Dzekov, Norman A Mazer, Andrea D Coviello, Philip E Knapp, Kathleen Hally, Emma Pinjic, Mingzhu Yan, Thomas W Storer, Shalender Bhasin
Research Program in Men's Health: Aging and Metabolism, Boston Claude D Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts , Kronos Longevity Research Institute, Phoenix, Arizona3Phoenix VA Health Care System, Phoenix, Arizona , Research Program in Men's Health: Aging and Metabolism, Boston Claude D Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts11Institute for Aging Research, Hebrew SeniorLife, Boston, Mass , Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles , Kronos Longevity Research Institute, Phoenix, Arizona5DWR Department of Geriatric Medicine, University of Oklahoma, Oklahoma City , Los Angeles Biomedical Research Institute, Division of Cardiology, Harbor-UCLA Medical Center, Torrance, California , Research Program in Men's Health: Aging and Metabolism, Boston Claude D Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts , Division of Cardiology, Boston University School of Medicine, Boston, Massachusetts , Division of Endocrinology, Metabolism, and Molecular Medicine, Charles R Drew University of Medicine and Science, Los Angeles, California , Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland10Division of Endocrinology, Boston University School of Medicine, Boston, Massachusetts , Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland , Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland , Research Program in Men's Health: Aging and Metabolism, Boston Claude D Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts , Research Program in Men's Health: Aging and Metabolism, Boston Claude D Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts , Atherosclerosis Research Unit, Keck School of Medicine, University of Southern California, Los Angeles , Research Program in Men's Health: Aging and Metabolism, Boston Claude D Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts , Research Program in Men's Health: Aging and Metabolism, Boston Claude D Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts