Safety and efficacy of anastrozole for the treatment of pubertal gynecomastia: a randomized, double-blind, placebo-controlled trial.
Pubertal gynecomastia is thought to result from transient imbalances between estrogen and androgen concentrations. Anastrozole (ARIMIDEX), a potent and selective aromatase inhibitor, decreases estrogen and increases testosterone concentrations in pubertal boys. The safety and efficacy of anastrozole for the treatment of pubertal gynecomastia were evaluated. In a randomized, double-blind, placebo-controlled study of 80 boys, aged 11-18 yr, with pubertal gynecomastia that had not reduced over a 3-month interval, subjects received either anastrozole (1 mg) or placebo once daily for 6 months. A response was defined as a 50% or greater reduction in the calculated volume of both breasts combined using ultrasonography measurements. A comparison of response rates was performed using logistic regression analysis. Secondary end points included changes in serum hormone concentrations. The percentage of patients with a response was 38.5% for the anastrozole group and 31.4% for the placebo group (odds ratio, 1.513; 95% confidence interval, 0.496-4.844; P = 0.47). At 6 months, the median percent change in the testosterone/estradiol ratio was 166% for the anastrozole group and 39% for the placebo group. Anastrozole treatment was well tolerated. In patients with pubertal gynecomastia, no significant difference in the percentage of patients with a 50% or greater reduction in total breast volume, as calculated from ultrasonography measurements, was demonstrated between the anastrozole and placebo groups.
Plourde
Paul V
PV
AstraZeneca Pharmaceuticals LP, Chesapeake 2B-126, 1800 Concord Pike, P.O. Box 15437, Wilmington, Delaware 19850-5437, USA. paul.plourde@astrazeneca.com
Reiter
Edward O
EO
Jou
Hann-Chang
HC
Desrochers
Paul E
PE
Rubin
Stephen D
SD
Bercu
Barry B
BB
Diamond
Frank B
FB
Backeljauw
Philippe F
PF
D000293:Adolescent; D000077384:Anastrozole; D002648:Child; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D004958:Estradiol / Q000097:blood; D006177:Gynecomastia / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D008297:Male; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use*; D013739:Testosterone / Q000097:blood; D014230:Triazoles / Q000009:adverse effects / Q000627:therapeutic use*
D004791:Enzyme Inhibitors; D009570:Nitriles; D014230:Triazoles; D000077384:Anastrozole; D013739:Testosterone; D004958:Estradiol