Korean J Urol.  2011 Jul;52(7):479-484.

Efficacy and Tolerability of Tamsulosin 0.4 mg in Patients with Symptomatic Benign Prostatic Hyperplasia

• Chung JW
• Choi SH
• Kim BS
• Kim TH
• Yoo ES
• Kim CI
• Lee KS
• Kwon TG

Abstract

PURPOSE
To evaluate the efficacy and tolerability of tamsulosin 0.4 mg once daily in Korean patients with symptomatic benign prostatic hyperplasia (BPH) and investigate whether tamsulosin 0.4 mg can improve symptoms in patients with refractory lower urinary tract symptoms (LUTS) who were previously receiving tamsulosin 0.2 mg once daily.
MATERIALS AND METHODS
A total of 116 patients from 3 urology centers participated. All study subjects entered a nonblind phase consisting of 8 weeks of tamsulosin 0.2 mg monotherapy followed by an additional 8 weeks of tamsulosin 0.2 mg (0.2 mg group) or 8 weeks of tamsulosin 0.4 mg (0.4 mg group). At week 8, we chose the 0.4 mg group on the basis of International Prostate Symptom Score (IPSS), quality of life (QoL), maximal urinary flow rate (Qmax), and adverse effects. At week 16, we compared the efficacy and tolerability of tamsulosin between the 0.2 and 0.4 mg groups.
RESULTS
A total of 26 patients (22.4%) were escalated to tamsulosin 0.4 mg at week 8. There were significant differences in IPSS, QoL, and Qmax at week 8 in both groups. There were significant differences in improvement in IPSS, QoL, Qmax, and postvoid residual urine volume from baseline to week 16 in both groups. There were no significant differences in efficacy or tolerability between the groups at week 16.
CONCLUSIONS
Our trial demonstrated that tamsulosin 0.4 mg has favorable efficacy and tolerability in Korean patients with symptomatic BPH refractory to tamsulosin 0.2 mg. No patients experienced any serious adverse effects when we escalated the dose of tamsulosin to 0.4 mg.

Keyword

Prostatic hyperplasia; Tamsulosin

MeSH Terms

Humans
Lower Urinary Tract Symptoms
Prostate
Prostatic Hyperplasia
Quality of Life
Sulfonamides
Urology
Sulfonamides

Figure

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  FIG. 1 Study design: tamsulosin 0.2 mg once daily monotherapy for 8 weeks followed by 8 weeks of additional tamsulosin 0.2 mg once daily or tamsulosin 0.4 mg once daily monotherapy.

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  FIG. 2 Mean total International Prostate Symptom Score (IPSS) at baseline and at week 16 in the 0.2 mg group (tamsulosin 0.2 mg once daily) and the 0.4 mg group (tamsulosin 0.4 mg once daily) (n=116). 0.2 mg group (n=90): tamsulosin 0.2 mg once daily, 0.4 mg group (n=26): tamsulosin 0.4 mg once daily, a: p<0.001 versus baseline, b: p<0.001 versus baseline.

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  FIG. 3 Change from baseline to week 8 and week 16 in total IPSS (International Prostate Symptom Score) in the 0.2 and 0.4 mg group, 0.2 mg group: 8 weeks tamsulosin 0.2 mg once daily+additional 8 weeks tamsulosin 0.2 mg once daily, 0.4 mg group: 8 weeks tamsulosin 0.2 mg once daily+additional 8 weeks tamsulosin 0.4 mg once daily.

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