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Safety and Efficacy of Anastrozole for the Treatment of Pubertal Gynecomastia: A Randomized, Double-Blind, Placebo-Controlled Trial

AstraZeneca Pharmaceuticals LP (P.V.P., H.-C.J., P.E.D., S.D.R.), Wilmington, Delaware 19850; Baystate Medical Center-Children’s Hospital (E.O.R.), Springfield, Massachusetts 01199; University of South Florida (B.B.B., F.B.D.), St. Petersburg, Florida 33701; and Cincinnati Children’s Hospital Medical Center (P.F.B.), Cincinnati, Ohio 45229

Address all correspondence and requests for reprints to: Dr. Paul V. Plourde, AstraZeneca Pharmaceuticals LP, Chesapeake 2B-126, 1800 Concord Pike, P.O. Box 15437, Wilmington, Delaware 19850-5437. E-mail: paul.plourde{at}astrazeneca.com.

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.

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