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From: pete
Date: 6/4/2002
Time: 11:30:23 AM
Remote Name: 213.122.151.249
EFFECT OF THE DUAL 5a-REDUCTASE INHIBITOR DUTASTERIDE ON ENDOCRINE PARAMETERS Claus G Roehrborn*, Dallas, TX; Gerald L Andriole, St Louis, MO; Curtis Nickel, Ontario, Canada; Peter Boyle, Milan, Italy
Introduction and Objectives: Inhibition of the 5a-reductase type II isoenzyme causes a reduction in circulating levels of dihydrotestosterone (DHT). Effects on other hormones such as testosterone (T) and luteinizing hormone (LH) have not been well characterized. Our objectives were to study the impact of dutasteride (D), a dual inhibitor of 5a-reductase types I and II, on circulating androgenic hormones.
Methods: Three 2-year multi-center, double-blind, placebo-controlled studies were conducted (n = 4325);D was administered at a dose of 0.5 mg/day. Inclusion criteria were: moderate to severe symptoms (AUA-SI ³ 12); prostate volume ³ 30 ml; PSA ³ 1.5 ng/ml to £ 10.0 ng/ml; and maximum flow rate (Qmax) £ 15 ml/sec. DHT and T were measured in the 3 studies in a subset of the total patient population at baseline, 1, 3, 6, 12, 18 and 24 months and in all patients at baseline, month 12 and 24. LH was measured in all patients in 1 of the 3 studies at months 6, 12, 18 and 24.
Results: The table shows the median % change from baseline for DHT, T and LH at each timepoint. The overall median%change from baseline in D-treated subjects for DHT at month 24 was -93.7% (SD=17) and for T 19.6% (SD=40); LH increased by 21.2% (SD=161). The decrease in DHT for D-treated subjects was predictable with 97% of the subjects achieving at least a 70% reduction, 95% achieving at least an 80% reduction, and 81% achieving at least a 90% reduction at month 24. The changes in LH and T were small and not regarded as clinically significant.
Conclusions: The new dual 5a-reductase inhibitor D induces early hormonal changes with a near total reduction in serum DHT as early as 1 month. The overall reduction in DHT is much greater than that usually observed with finasteride (~70%) and is less variable. Serum testosterone increases early and remains constant over the 24-month treatment period.
1 mo 3 mo 6 mo 12 mo 18 mo 24 mo
DHT/D (n=195) -91 (15) -92.7 (12) -93.6 (14) -94.4 (7) -94.7 (16) -94.1 (14)
DHT/Plc (n=195) 9.2 (51) 10.4 (52) 13.0 (48) 4.3 (39) 3.9 (44) 6.1 (60)
T/D (n=195) 18.1 (37) 18.4 (36) 19.3 (36) 22.7 (33) 13.9 (39) 16.1 (38)
T/Plc(n=195) 3.4 (28) 8.1 (27) 5.2 (36) 0.6 (25) 2.7 (27) 5.2 (34)
LH/D (n=770) NA NA 11.8 (248) 20.2 (310) 22.6 (57) 21.2 (161)
LH/Plc (n=753) NA NA 4.2 (66) 5.1 (110) 9.7 (79) 5.7 (73)
From: <Default>
Date: 26 Aug 2007
Time: 01:21:50
Remote Name: 84.109.83.61
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