Tamsulosin: 3-year long-term efficacy and safety in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction: analysis of a European, multinational, multicenter, open-label study. European Tamsulosin Study Group.
OBJECTIVE
This open-label extension study evaluated the efficacy and safety of tamsulosin (0.4 mg as a modified release formulation) once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO) treated for up to 3 years.


METHODS
Patients were enrolled from two European, 12-week, placebo-controlled trials. This analysis reports on 355 patients randomized originally to tamsulosin (n = 244) or placebo (n = 111) in the two placebo-controlled trials with follow-up data for up to 3 years.


RESULTS
The significant improvements in the primary efficacy parameters, maximum urinary flow rate (Q(max)) and total Boyarsky symptom score that were observed during the placebo-controlled trials were sustained throughout the long-term extension study for up to 3 years in patients who remained on therapy. Mean Q(max) increased from baseline (range 0.7-1.8 ml/s; p < 0.05 vs. baseline) and remained between 11.5 and 12 ml/s during the entire follow-up period. Total Boyarsky symptom score also improved from baseline (range -3.7 to -4.1 (or -39 to -44%); p < 0.001 vs. baseline). Similarly, the percentage of treatment responders, defined as an increase in Q(max) of >/=30% or a decrease in total symptom score of >/=25%, remained constant throughout the 3-year period. The number of patients who had a clinically significant total Boyarsky symptom score response ranged between 69 and 80%. During the 3-year study period, 95 patients (27%) experienced an adverse event considered to be possibly or probably related to study medication, the most common of which (occurring in </=6% of patients) were dizziness and abnormal ejaculation. There were no clinically significant changes in blood pressure or pulse rate during the study.


CONCLUSIONS
Long-term tamsulosin therapy is safe, well-tolerated and improvements in urinary flow and symptoms are maintained in patients with LUTS suggestive of BPO who remain on treatment for up to 3 years.
Schulman
C C
CC
Erasmus University Hospital, Brussels, Belgium.
Cortvriend
J
J
Jonas
U
U
Lock
T M
TM
Vaage
S
S
Speakman
M J
MJ
D000284:Administration, Oral; D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001794:Blood Pressure / Q000187:drug effects; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000032:analysis; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D013449:Sulfonamides / Q000627:therapeutic use*; D000077409:Tamsulosin; D016896:Treatment Outcome; D014554:Urination / Q000187:drug effects
D000317:Adrenergic alpha-Antagonists; D013449:Sulfonamides; D017430:Prostate-Specific Antigen; D000077409:Tamsulosin