Effect of Doxazosin Gastrointestinal Therapeutic System 4 mg vs Tamsulosin 0.2 mg on Nocturia in Chinese Men With Lower Urinary Tract Symptoms: A Prospective, Multicenter, Randomized, Open, Parallel Study

• Published in: Urology (Ridgewood, N.J.) Vol. 78; no. 3; pp. 636 - 640
• Main Authors: Zhang, Kai, Yu, Wei, Jin, Jie, Ye, Haiyun, Wang, Xiaofeng, Zhang, Ning, Yang, Yong, Zhong, Chenyang, Wan, Ben
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.09.2011; Elsevier
• Subjects: Adrenergic alpha-Antagonists - therapeutic use; Aged; Aged, 80 and over; Biological and medical sciences; Doxazosin - therapeutic use; Humans; Male; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Nocturia - complications; Nocturia - drug therapy; Nocturia - physiopathology; Prostatic Hyperplasia - complications; Sulfonamides - therapeutic use; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland; Urination Disorders - complications; Urology; Asia; China; Human; Doxazosin; Nephrology; Urinary system disease; Controlled release form; Quinazoline derivatives; Multicenter study; α1-Adrenergic receptor; Male; Urinary tract disease; Urology; Prospective; Voiding dysfunction; Randomization; Tamsulosin; Alpha blocking agent; Sulfonamides; Adult; Antihypertensive agent; Chinese; Antagonist; Lower urinary tract symptoms; Comparative study; Nocturia
• ISSN: 0090-4295; 1527-9995
• DOI: 10.1016/j.urology.2011.04.038

Objective To compare the efficacy of the doxazosin gastrointestinal therapeutic system (doxazosin-GITS) 4 mg and tamsulosin 0.2 mg on nocturia in Chinese men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). Methods Data were analyzed from a prospective, multicenter, randomized, open, parallel study of Chinese men aged 50-84 years with LUTS/BPH. Two hundred patients were randomized to receive daily treatment with 4 mg doxazosin-GITS (n = 100) or 0.2 mg tamsulosin (n = 100) for 8 weeks. Nocturia was assessed by question 7 of the International Prostate Symptom Score (IPSS-question 7) and a frequency–volume chart (FVC) at weeks 4 and 8. Self-reported quality of sleep and quality of life by the last question of the IPSS questionnaire were also evaluated. Results A total of 189 patients (94 receiving doxazosin-GITS, 95 tamsulosin) completed the study. The reduction from baseline in mean nocturia was greater with doxazosin-GITS than tamsulosin by the FVC (1.7 vs 1.3 at week 4; 2.1 vs 1.7 at week 8, both P = .001) and by the IPSS-question 7 (1.5 vs 1.1 at 4 weeks, P = .001; 2.0 vs 1.6 at 8 weeks, P < .001). The patients who reported improved quality of sleep was significantly more with doxazosin-GITS than tamsulosin (43.6% vs 27.4% at 4 weeks, P = .020; 81.9% vs 67.4% at 8 weeks, P = .022), and quality of life was better with doxazosin-GITS (2.5 vs 2.8 at 4 weeks, P = .001; 2.1 vs 2.5 at 8 weeks, P < .001). Conclusion In Chinese patients with LUTS/BPH, doxazosin-GITS is slightly better than tamsulosin in reducing the frequency of nocturia.