Long-term use of tamsulosin to treat lower urinary tract symptoms/benign prostatic hyperplasia.

Abstract

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