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Estrogen reduction by aromatase inhibition for benign prostatic hyperplasia: Results of a double‐blind, placebo‐controlled, randomized clinical trial using two doses of the aromatase‐inhibitor atamestane
Author(s) -
Radlmaier Albert,
Eickenberg Hans U.,
Fletcher Matthew S.,
Fourcade Richard O.,
Santos José M. Reis,
van Aubel Olav G.J. M.,
Bono Aldo V.
Publication year - 1996
Publication title -
the prostate
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.295
H-Index - 123
eISSN - 1097-0045
pISSN - 0270-4137
DOI - 10.1002/(sici)1097-0045(199610)29:4<199::aid-pros1>3.0.co;2-7
Subject(s) - placebo , medicine , aromatase inhibitor , aromatase , estrone , estrogen , hyperplasia , urology , randomized controlled trial , endocrinology , finasteride , prostate , pathology , breast cancer , cancer , alternative medicine
BACKGROUND The concept of estrogen withdrawal by an aromatase inhibitor in the treatment of benign prostatic hyperplasia (BPH) was assessed in a prospective, randomized, double‐blind, placebo‐controlled multicenter trial. METHODS Two hundred and ninety‐two patients with clinical symptoms of BPH were randomly allocated to one of the following treatments for 48 weeks: placebo or the selective aromatase inhibitor, atamestane, at a daily dose of 100 mg or 300 mg. Both doses of atamestane significantly reduced serum concentrations of estradiol and estrone, and produced a slight, dose‐dependent, counter‐regulatory increase in peripheral androgen concentration. RESULTS Clinical symptoms improved during treatment in all three groups. Even after 48 weeks, the effect of active treatment did not exceed the effect seen with placebo. Overall tolerance of 100 mg atamestane was excellent, but 300 mg showed a slightly increased incidence of side effects compared with placebo. CONCLUSIONS The conclusion from this study is that the reduction in estrogen concentration using the selective aromatase inhibitor atamestane has no effect on clinically established BPH. © 1996 Wiley‐Liss, Inc.