The Efficacy and Safety of Doxazosin GITS in Patients with Benign Prostatic Hyperplasia / 대한비뇨기과학회지

ABSTRACT

PURPOSE: The doxazosin-gastrointestinal therapeutic system (GITS) greatly minimizes the need for titration by changing the drug-delivery rate and pharmacokinetic profiles. This multi-center study was designed to evaluate the efficacy and safety of doxazosin GITS in patients with BPH when used under the standard usage conditions. MATERIALS AND METHODS: A total of 487 men, aged 40 years or over, with clinical evidence of BPH were enrolled. Demographic profiles were gathered at the baseline and the patients followed up at 4 and 8 weeks for dose adjustment and final assessment of the efficacy, respectively. The efficacy, measured in terms of the International Prostate Symptom Score (IPSS), quality of life (QOL), maximum urinary flow rate (Qmax) and post-voiding residual volume were assessed on each visit. RESULTS: On completion of the study, the mean change in the IPSS and QOL from the baseline were -6.9+/-5.7 (p<0.01) and -1.4+/-1.1 (p<0.01), respectively. The Qmax and post-voiding residual volume were significantly improved compared to the baseline (p<0.01). Decreases in the mean systolic and diastolic blood pressures from the baseline in hypertensive patients (n=139) were significantly greater than in normotensive patients (n=309). There were 25 cases (5.1%) among 487 patients in which adverse events, such as dizziness, impotence, dryness of mouth and postural hypotension, were reported. CONCLUSIONS: In treating BPH, doxazosin GITS significantly improved the IPSS, QOL, Qmax and post-voiding residual volume. Doxazosin GITS is a safe and effective drug for the treatment of BPH in Korean men when used in a standard clinical setting.