Y J Na1, Y L Guo, F L Gu. 1. Institute of Urology, Beijing Medical University, China.
Abstract
To examine the clinical usefulness of selective and non-selective alpha 1-adrenoceptor antagonists, we compared a selective (tamsulosin) and non-selective (terazosin) alpha 1-adrenoceptor antagonists in the treatment of Chinese patients with benign prostatic hyperplasia (BPH). The study was a single-blind, randomized, multicenter design to compare a fixed dose of tamsulosin (0.2 mg) or terazosin (2 mg) given once daily after breakfast for four weeks. A total of 212 patients were enrolled with 201 patients included in the analysis. The primary variables assessed were changes in total International Prostatic Symptom Score (IPSS), maximum urinary flow rate (Qmax), and average urinary flow rate (AFR) four weeks after dosing. Adverse events were recorded through the treatment period. Both tamsulosin and terazosin produced significant improvements in total IPSS (total score of 11.8 +/- 4.5; decrease in 45.1% and total score of 13.3 +/- 5.3; decrease in 39.0%, respectively) (p < 0.001), Qmax (13.2 +/- 4.1 mL/s, 37.5% increase and 13.6 +/- 3.6 mL/s, 30.8% increase, respectively) (p < 0.001) and AFR (7.7 +/- 3.3 mL/s, 37.5% increase and 7.8 +/- 3.1 mL/s, 25.8% increase, respectively) (p < 0.001) at endpoint. Tamsulosin was superior to terazosin in improvement of total IPSS (p < 0.05) and AFR (p < 0.05). The incidence of adverse events by administration of tamsulosin was less than that by terazosin (13 and 50, respectively; p < 0.01). Among the adverse event, incidence of dizziness (p < 0.001) and hypotension (p < 0.01) by administration of terazosin were significantly greater than that by tamsulosin. Both systolic and diastolic blood pressure of sitting position decreased significantly in patients treated with terazosin (p < 0.01). These results suggest that tamsulosin, a selective alpha 1A-adrenoceptor antagonist, was superior to terazosin, a non-selective alpha 1-adrenoceptor antagonist, in efficacy and adverse events in patients with symptomatic BPH.
RCT Entities:
To examine the clinical usefulness of selective and non-selective alpha 1-adrenoceptor antagonists, we compared a selective (tamsulosin) and non-selective (terazosin) alpha 1-adrenoceptor antagonists in the treatment of Chinese patients with benign prostatic hyperplasia (BPH). The study was a single-blind, randomized, multicenter design to compare a fixed dose of tamsulosin (0.2 mg) or terazosin (2 mg) given once daily after breakfast for four weeks. A total of 212 patients were enrolled with 201 patients included in the analysis. The primary variables assessed were changes in total International Prostatic Symptom Score (IPSS), maximum urinary flow rate (Qmax), and average urinary flow rate (AFR) four weeks after dosing. Adverse events were recorded through the treatment period. Both tamsulosin and terazosin produced significant improvements in total IPSS (total score of 11.8 +/- 4.5; decrease in 45.1% and total score of 13.3 +/- 5.3; decrease in 39.0%, respectively) (p < 0.001), Qmax (13.2 +/- 4.1 mL/s, 37.5% increase and 13.6 +/- 3.6 mL/s, 30.8% increase, respectively) (p < 0.001) and AFR (7.7 +/- 3.3 mL/s, 37.5% increase and 7.8 +/- 3.1 mL/s, 25.8% increase, respectively) (p < 0.001) at endpoint. Tamsulosin was superior to terazosin in improvement of total IPSS (p < 0.05) and AFR (p < 0.05). The incidence of adverse events by administration of tamsulosin was less than that by terazosin (13 and 50, respectively; p < 0.01). Among the adverse event, incidence of dizziness (p < 0.001) and hypotension (p < 0.01) by administration of terazosin were significantly greater than that by tamsulosin. Both systolic and diastolic blood pressure of sitting position decreased significantly in patients treated with terazosin (p < 0.01). These results suggest that tamsulosin, a selective alpha 1A-adrenoceptor antagonist, was superior to terazosin, a non-selective alpha 1-adrenoceptor antagonist, in efficacy and adverse events in patients with symptomatic BPH.
Authors: Sung Ryul Shim; Jae Heon Kim; In Ho Chang; In Soo Shin; Sung Dong Hwang; Khae Hwan Kim; Sang Jin Yoon; Yun Seob Song Journal: Yonsei Med J Date: 2016-03 Impact factor: 2.759