OBJECTIVE: The pharmacological action of 5-alpha-reductase inhibitors (5-ARI) would reduce angiogenesis associated with benign prostatic hyperplasia (BPH), thereby decreasing peroperative bleeding during transurethral resection of the prostate (TURP). Dutasteride, a double inhibitor of 5-alpha-reductase iso-enzymes types 1 and 2, was not been previously studied in the context of reduction of peroperative bleeding related to TURP. MATERIAL AND METHODS: We conducted a multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of dutasteride 0.5 mg per day, in peroperative bleeding related to TURP for BPH in patients over the age of 50 years with a prostatic volume greater than 30 cm3. Treatment was administered for 4 weeks before the operation. The primary endpoint was haemoglobin, expressed in grams, and expressed in relation to the weight of prostate resected, also expressed in grams. RESULTS:59 patients were evaluated (32 treated withdutasteride and 27 treated with placebo). A significant difference in peroperative bleeding was observed between the dutasteride group (1.944 +/- 1.816 g of Hb/g of prostate resected) and the placebo group (1.401 +/- 1.021 g of Hb/g of prostate resected). Preoperative treatment was well tolerated. CONCLUSION: The working hypothesis of the study was not confirmed due to the low bleeding rate in the placebo group and the results suggest that a longer duration of treatment with dutasteride would reduce intraoperative and postoperative bleeding in TURP.
RCT Entities:
OBJECTIVE: The pharmacological action of 5-alpha-reductase inhibitors (5-ARI) would reduce angiogenesis associated with benign prostatic hyperplasia (BPH), thereby decreasing peroperative bleeding during transurethral resection of the prostate (TURP). Dutasteride, a double inhibitor of 5-alpha-reductase iso-enzymes types 1 and 2, was not been previously studied in the context of reduction of peroperative bleeding related to TURP. MATERIAL AND METHODS: We conducted a multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of dutasteride 0.5 mg per day, in peroperative bleeding related to TURP for BPH in patients over the age of 50 years with a prostatic volume greater than 30 cm3. Treatment was administered for 4 weeks before the operation. The primary endpoint was haemoglobin, expressed in grams, and expressed in relation to the weight of prostate resected, also expressed in grams. RESULTS: 59 patients were evaluated (32 treated with dutasteride and 27 treated with placebo). A significant difference in peroperative bleeding was observed between the dutasteride group (1.944 +/- 1.816 g of Hb/g of prostate resected) and the placebo group (1.401 +/- 1.021 g of Hb/g of prostate resected). Preoperative treatment was well tolerated. CONCLUSION: The working hypothesis of the study was not confirmed due to the low bleeding rate in the placebo group and the results suggest that a longer duration of treatment with dutasteride would reduce intraoperative and postoperative bleeding in TURP.
Authors: Michael K Brawer; Danil V Makarov; Alan W Partin; Claus G Roehrborn; J Curtis Nickel; Michael B Chancellor; Dean G Assimos; Ellen Shapiro; Jacob Rajfer Journal: Rev Urol Date: 2007