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.


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.
Chung
Byung Ha
BH
Yonsei University College of Medicine, Seoul, Korea. chung646@yumc.yonsei.ac.kr
Hong
Sung Joon
SJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D017292:Doxazosin / Q000008:administration & dosage* / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000150:complications* / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy*; D011788:Quality of Life; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D003692:Delayed-Action Preparations; D017292:Doxazosin