E Lee1, C Lee. 1. Department of Urology, Seoul National University College of Medicine, Korea.
Abstract
OBJECTIVE: To compare the efficacy and safety of a fixed dose (0.2 mg) of tamsulosin, a selective alpha 1A-adrenoreceptor antagonist, with an increasing dose (1-5 mg) of terazosin, a non-selective antagonist, in the treatment of urinary outflow obstruction associated with benign prostatic hyperplasia (BPH) in Korean patients. PATIENTS AND METHODS: The study comprised a single-blind and randomized design with tamsulosin or terazosin taken once daily for 8 weeks. A total of 98 patients was enrolled, with 72 patients included in the analyses after 4 and 8 weeks. The primary variables assessed were changes in the maximum urinary flow rate Qmax and the total International Prostate Symptom Score (IPSS), with the post-void residual urine volume, 'obstructive' and 'irritative' questions in the IPSS, and the investigators' global assessment of efficacy also determined. The number of patients with a clinically significant response to treatment with tamsulosin or terazosin was determined and defined as those with > 20% improvement from the baseline Qmax or > 20% decrease in total IPSS. Adverse reactions possibly or probably related to study medication were recorded throughout the treatment period. RESULTS: Both tamsulosin and terazosin produced similar significant improvements in subjective and objective symptoms of urinary outflow obstruction (P > 0.05). Systolic and diastolic (standing) blood pressures decreased significantly in patients treated with terazosin (P < 0.05). The adverse reactions, most frequently dry mouth and dizziness which were usually mild and transient, were significantly higher in patients on terazosin (18 patients, versus one on tamsulosin, P < 0.001). The changes led to discontinuation of therapy in two patients on terazosin. CONCLUSION:Tamsulosin was as effective as terazosin in treating urinary outflow obstruction associated with BPH, but had a markedly better safety profile.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of a fixed dose (0.2 mg) of tamsulosin, a selective alpha 1A-adrenoreceptor antagonist, with an increasing dose (1-5 mg) of terazosin, a non-selective antagonist, in the treatment of urinary outflow obstruction associated with benign prostatic hyperplasia (BPH) in Korean patients. PATIENTS AND METHODS: The study comprised a single-blind and randomized design with tamsulosin or terazosin taken once daily for 8 weeks. A total of 98 patients was enrolled, with 72 patients included in the analyses after 4 and 8 weeks. The primary variables assessed were changes in the maximum urinary flow rate Qmax and the total International Prostate Symptom Score (IPSS), with the post-void residual urine volume, 'obstructive' and 'irritative' questions in the IPSS, and the investigators' global assessment of efficacy also determined. The number of patients with a clinically significant response to treatment with tamsulosin or terazosin was determined and defined as those with > 20% improvement from the baseline Qmax or > 20% decrease in total IPSS. Adverse reactions possibly or probably related to study medication were recorded throughout the treatment period. RESULTS: Both tamsulosin and terazosin produced similar significant improvements in subjective and objective symptoms of urinary outflow obstruction (P > 0.05). Systolic and diastolic (standing) blood pressures decreased significantly in patients treated with terazosin (P < 0.05). The adverse reactions, most frequently dry mouth and dizziness which were usually mild and transient, were significantly higher in patients on terazosin (18 patients, versus one on tamsulosin, P < 0.001). The changes led to discontinuation of therapy in two patients on terazosin. CONCLUSION:Tamsulosin was as effective as terazosin in treating urinary outflow obstruction associated with BPH, but had a markedly better safety profile.
Authors: R F Schäfers; B Fokuhl; A Wasmuth; H Schumacher; K Taguchi; C de Mey; T Philipp; M C Michel Journal: Br J Clin Pharmacol Date: 1999-01 Impact factor: 4.335
Authors: Petros Sountoulides; Marleen M van Dijk; Hessel Wijkstra; Jean J M C H de la Rosette; Martin Christian Michel Journal: World J Urol Date: 2009-10-09 Impact factor: 4.226