Effects of aromatase inhibition in hypogonadal older men: a randomized, double-blind, placebo-controlled trial.
OBJECTIVE
To assess the effects of sustained aromatase inhibition in older hypogonadal men.


METHODS
In a 1-year randomized, double-blind, placebo-controlled trial, 88 men, aged 60 and older with testosterone levels between 5.2 and 10.4 nmol/L on a single measure or between 10.4 and 12.1 nmol/L on two consecutive measures, and symptoms of hypogonadism were recruited. Subjects received either anastrozole 1 mg daily or placebo.


METHODS
Changes in gonadal steroid hormone levels, body composition (by computerized tomography (CT) and dual x-ray absorptiometry (DXA)), strength, prostate specific antigen (PSA), symptoms of benign prostatic hypertrophy (BPH), hematocrit and lipid levels were assessed.


RESULTS
Testosterone levels increased from 11.2 +/- 3.3 nmol/L at baseline to 18.2 +/- 4.8 nmol/L at month 3 (p < 0.0001 vs. placebo) while bioavailable testosterone levels increased from 2.7 +/- 0.8 nmol/L at baseline to 5.4 +/- 1.7 nmol/L at month 3 (p < 0.0001 vs. placebo). Testosterone and biotestosterone levels peaked at month 3 and then declined by month 12 (though they remained significantly higher than baseline and greater than placebo). Estradiol levels decreased from 55.8 +/- 15.4 pmol/L at baseline to 42.2 +/- 13.6 pmol/L at month 3 and then remained stable (p < 0.0001). Body composition and strength did not change, nor did PSA, BPH symptoms, hematocrit or lipid levels.


CONCLUSIONS
Anastrozole administration normalized androgen production in older hypogonadal men and decreased estradiol production modestly. These alterations did not improve body composition or strength.
Burnett-Bowie
Sherri-Ann M
SA
Endocrine Unit, Massachusetts General Hospital, Boston, MA, USA. sburnett-bowie@partners.org.
Roupenian
Kristen C
KC
Dere
Melissa E
ME
Lee
Hang
H
Leder
Benjamin Z
BZ
D000368:Aged; D000077384:Anastrozole; D047072:Aromatase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D001682:Biological Availability; D001823:Body Composition / Q000187:drug effects; D015232:Dinoprostone / Q000097:blood; D004311:Double-Blind Method; D006801:Humans; D007006:Hypogonadism / Q000097:blood* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D017063:Outcome Assessment, Health Care; D013739:Testosterone / Q000097:blood*; D014230:Triazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*
D047072:Aromatase Inhibitors; D009570:Nitriles; D014230:Triazoles; D000077384:Anastrozole; D013739:Testosterone; D015232:Dinoprostone