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  • Title: Long-term use of tamsulosin to treat lower urinary tract symptoms/benign prostatic hyperplasia.
    Author: Schulman CC, Lock TM, Buzelin JM, Boeminghaus F, Stephenson TP, Talja M, European Tamsulosin Study Group.
    Journal: J Urol; 2001 Oct; 166(4):1358-63. PubMed ID: 11547074.
    Abstract:
    PURPOSE: 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. MATERIALS AND 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.
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