Long-term follow-up study to evaluate the efficacy and safety of the doxazosin gastrointestinal therapeutic system in patients with benign prostatic hyperplasia with or without concomitant hypertension.

OBJECTIVE: To assess the long-term efficacy and safety of extended-release doxazosin gastrointestinal therapeutic system (GITS) under routine clinical care conditions over 12 months in Korean men with benign prostatic hyperplasia (BPH) with and without coexisting hypertension. PATIENTS AND METHODS: In this open-label, multicentre, uncontrolled, flexible-dose study, 475 men (> or =40 years old) with clinical evidence of BPH were enrolled from 40 centres. Patients were evaluated at baseline and at 1, 2, 6 and 12 months of treatment. The primary efficacy variable was the Clinicians Global Assessment of Change (CGAC; improved, no change, or worse). Secondary efficacy variables were International Prostate Symptom Score (IPSS), quality of life (QoL), maximum urinary flow rate (Q(max)), and postvoid residual (PVR) urine volume. Adverse events (AEs) and blood pressure (BP) were also recorded.
RESULTS: In all, 186 patients completed the study; based on the CGAC, most patients (155, 83.8%) improved and 31 (16.2%) had no change in symptoms. The mean (sd) change in the IPSS and QoL from baseline were -9.0 (6.8) and -1.6 (1.4), respectively (both P < 0.05). The Q(max) and PVR urine volume were significantly better than at baseline, with means of 10.5 (4.3) vs 13.7 (6.3), and 39.1 (37.0) vs 23.2 (33.7); P < 0.05). The decrease in systolic BP (SBP) and diastolic BP (DBP) from baseline in 52 hypertensive patients was significantly greater than in 134 normotensive patients, at (SBP/DBP) -9.5 (18.4)/-13.4 (10.9) vs -3.3 (12.5)/-1.4 (9.5); P < 0.05). A total of 47 AEs were reported in 41 of 475 patients (8.6%); the most common were dizziness (2.7%), erectile dysfunction (1.1%), dry mouth (1.1%), prostatic disorder (0.6%), and postural hypotension (0.4%).
CONCLUSIONS: After 12 months, treatment with doxazosin GITS resulted in an improvement in > 83% of patients based on the CGAC, with significant improvements in IPSS, QoL, Q(max,) and PVR urine volume. Doxazosin GITS was effective and well tolerated as long-term therapy for Korean patients with BPH.