Korean J Urol.  2012 Mar;53(3):178-183.

Efficacy and Safety of Tamsulosin for Treating Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled, Open-Label Non-Inferiority Study

• Lee HS
• Kim SW
• Oh SJ
• Choo MS
• Lee KS

Abstract

PURPOSE
To compare the efficacy and safety of Sulosin D (PACIFICPHARMA, Korea) and Harnal D (ASTELLAS PHARMA KOREA, Korea) in treating patients with lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
MATERIALS AND METHODS
This randomized, controlled, open-label, multicenter non-inferiority study was conducted at four sites in Korea. We randomly assigned 123 patients with an International Prostate Symptom Score (IPSS) > or =12 to receive either Sulosin D or Harnal D treatment for 8 weeks. The primary outcome was the mean change in IPSS from baseline to endpoint. Secondary outcomes were the mean change from baseline to endpoint in IPSS quality of life subscores, maximum uroflowmetry (Qmax), and post-voiding residuals (PVR).
RESULTS
In all, 123 patients were randomly assigned (60 Sulosin D and 63 Harnal D). The changes in the total IPSS from baseline in the Sulosin D- and Harnal D-treated groups were -4.97 and -4.03, respectively. There were significant decreases compared with baseline in both groups. The mean difference (Sulosin D - Harnal D) was -0.91 (with a two-sided 90% confidence interval), inferring that Sulosin D was not inferior to Harnal D. The mean changes in the IPSS subscore, Qmax, and PVR from baseline were comparable between the groups (both p>0.05). During the treatment periods, the incidence of adverse events was 23.33% and 34.92% in the Sulosin D and Harnal D groups, respectively (p=0.1580).
CONCLUSIONS
We demonstrate the non-inferiority of Sulosin D to Harnal D in patients with lower urinary tract symptoms associated with BPH.

Keyword

Drugs, generic; Prostatic hyperplasia; Tamsulosin

MeSH Terms

Drugs, Generic
Humans
Incidence
Korea
Lower Urinary Tract Symptoms
Prostate
Prostatic Hyperplasia
Quality of Life
Sulfonamides
Drugs, Generic
Sulfonamides

Figure

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  FIG. 1 Flow diagram of patient allocation. ITT, intention-to-treat; PP, per-protocol.

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  FIG. 2 Comparison of patient's perception of treatment benefit between the two groups at 8 weeks.

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  FIG. 3 Comparison of global response assessment of treatment of benign prostatic hyperplasia between the two groups after 8 weeks of treatment (p=0.8132).

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