Efficacy and safety of tamsulosin hydrochloride compared to doxazosin in the treatment of Indonesian patients with lower urinary tract symptoms due to benign prostatic hyperplasia.
OBJECTIVE
The objective of the study was to compare the efficacy and safety of tamsulosin hydrochloride and doxazosin in patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).


METHODS
The safety and efficacy of tamsulosin (0.2 mg) and doxazosin (2 mg) was determined after once daily administration for 6 weeks in an open-label, randomized, multicenter study of 101 men with BPH. The International Prostatic Symptom Score (IPSS), maximal urinary flow rates (Qmax), average urinary flow rates (Qave) and residual urine were determined at baseline and again at 6 weeks as efficacy parameters. The primary parameters used for safety evaluation were vital signs (blood pressure and heart rate) and adverse events. The number of patients with a clinically significant response to treatment with tamsulosin or doxazosin was determined and defined as those with >20% improvement from the baseline Qmax or >20% decrease in total IPSS.


RESULTS
The total IPSS decreased significantly in both the tamsulosin and doxazosin groups compared to baseline. There was a significant difference in the decrease in total IPSS between two groups. Qmax, Qave and residual urine significantly improved only in the tamsulosin group. There were no significant differences in systolic blood pressure, diastolic blood pressure or heart rate profile in the tamsulosin group; however, doxazosin resulted in a significant difference in systolic and diastolic blood pressure. Tamsulosin was well tolerated; only three patients (6%) in the tamsulosin group reported an adverse event (dizziness) while 11 patients (22%) in the doxazosin group reported an adverse event (dizziness), one of whom withdrew from the study.


CONCLUSIONS
Tamsulosin was shown to be more effective than doxazosin in the treatment of LUTS due to BPH.
Rahardjo
Djoko
D
Subdivision of Urology, Department of Surgery University of Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
Soebadi
Doddy M
DM
Sugandi
Suwandi
S
Birowo
Ponco
P
Djati
Wahjoe
W
Wahyudi
Irfan
I
D000317:Adrenergic alpha-Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D017292:Doxazosin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications*; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077409:Tamsulosin; D016896:Treatment Outcome; D014522:Urethral Diseases / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D001748:Urinary Bladder Neck Obstruction / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D014563:Urodynamics / Q000187:drug effects
D000317:Adrenergic alpha-Antagonists; D013449:Sulfonamides; D000077409:Tamsulosin; D017292:Doxazosin