Long-term use of tamsulosin to treat lower urinary tract symptoms/benign prostatic hyperplasia.
OBJECTIVE
The long-term efficacy and safety of 0.4 mg. tamsulosin once daily were assessed in patients with lower urinary tract symptoms/benign prostatic hyperplasia treated for up to 4 years.


METHODS
A total of 516 patients were enrolled from 2 European open label studies that were extensions of 3 double-blind controlled studies.


RESULTS
Significant improvement in maximum urine flow and total Boyarsky symptom score during the controlled trials was sustained throughout the extension study for up to 4 years in patients who remained on therapy. The increase in mean maximum urine flow from baseline was 1.2 to 2.2 ml. per second (p <0.001) and it remained 11.5 to 12 ml. per second during followup. Total Boyarsky symptom score was decreased from baseline by 4.1 to 4.7 points (p <0.001). The incidence of treatment responders, defined as a 25% or greater decrease in total symptom score, remained stable throughout the 4-year period. Increasing the dose of tamsulosin from 0.4 to 0.8 mg. seemed to have no substantial additional benefit. During the 4 years of treatment 26% of patients had side effects that were considered possibly or probably drug related. However, only 5% of patients discontinued treatment because of drug related side effects. No clinically significant changes in blood pressure or pulse rate occurred during the study.


CONCLUSIONS
Long-term treatment with tamsulosin is safe and well tolerated in patients with lower urinary tract symptoms/benign prostatic hyperplasia. Improved efficacy was sustained during 4 years of followup.
Schulman
C C
CC
Erasmus University Hospital, Brussels, Belgium.
Lock
T M
TM
Buzelin
J M
JM
Boeminghaus
F
F
Stephenson
T P
TP
Talja
M
M
D058668:Adrenergic alpha-1 Receptor Antagonists; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000627:therapeutic use*; D000077409:Tamsulosin; D013997:Time Factors; D014555:Urination Disorders / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D014563:Urodynamics
D058668:Adrenergic alpha-1 Receptor Antagonists; D013449:Sulfonamides; D000077409:Tamsulosin