Effects of aromatase inhibition in hypogonadal older men: a randomized, double‐blind, placebo‐controlled trial

SAM Burnett‐Bowie, KC Roupenian… - Clinical …, 2009 - Wiley Online Library
SAM Burnett‐Bowie, KC Roupenian, ME Dere, H Lee, BZ Leder
Clinical endocrinology, 2009Wiley Online Library
Objective To assess the effects of sustained aromatase inhibition in older hypogonadal men.
Design and patients In a 1‐year randomized, double‐blind, placebo‐controlled trial, 88 men,
aged 60 years 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 with
symptoms of hypogonadism were recruited. Subjects received either anastrozole 1 mg daily
or placebo. Measurements Changes in gonadal steroid hormone levels, body composition …
Summary
Objective  To assess the effects of sustained aromatase inhibition in older hypogonadal men.
Design and patients  In a 1‐year randomized, double‐blind, placebo‐controlled trial, 88 men, aged 60 years 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 with symptoms of hypogonadism were recruited. Subjects received either anastrozole 1 mg daily or placebo.
Measurements  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), haematocrit 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). E2 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, haematocrit or lipid levels.
Conclusions  Anastrozole administration normalized androgen production in older hypogonadal men and decreased E2 production modestly. These alterations did not improve body composition or strength.
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