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Lee, Lee, Oh, Chung, and Korean Alfuzosin Study Group: Efficacy and Safety of Alfuzosin 10 mg Once Daily in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: A 6-Months Study in Real Life Practice
Original Article
Urological Oncology
Korean Journal of Urology

Korean Journal of Urology 2009; 50(4): 333-339.

Published online: 27 April 2009

DOI: https://doi.org/10.4111/kju.2009.50.4.333

Efficacy and Safety of Alfuzosin 10 mg Once Daily in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: A 6-Months Study in Real Life Practice

Seung Wook Lee, Seung Hwan Lee1, Cheol Young Oh2, Byung Ha Chung1; Korean Alfuzosin Study Group

Depatment of Urology, Eulji University College of Medicine, Seoul, Korea.

1Urological Science Institute, Yonsei University College of Medicine, Korea.

2Depatment of Urology, Hallym University College of Medicine, Chuncheon, Korea.

Correspondence to: Byung Ha Chung. Department of Urology, Urological Science Institute, Yonsei University College of Medicine, 146-92, Dogok-dong, Gangnam-gu, Seoul 135-720, Korea. TEL: 02-3497-3474, FAX: 02-3462-8887, chung646@yumc.yonsei.ac.kr

Received 5 December 2008       Accepted 11 February 2009

Copyright © The Korean Urological Association, 2009

Abstract

Purpose

The aim of the study was to evaluate the long-term safety profile and efficacy of Alfuzosin 10 mg once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH), under daily practice conditions in Korea.

Materials and Methods

In this 6-months, open-label, multicenter, noncomparative, observational study, 511 men were enrolled. International Prostate Symptom Score (IPSS), IPSS 8th question (bother score), maximum flow rate (Qmax), Danish Prostate Symptom Score (DAN-PSS) were evaluated at baseline and after 3, 6 months of treatment. Safety was analyzed in all patients exposed to alfuzosin (n=480). Analysis was performed at end-point in the intent to treat population (n=368).

Results

Of the 511 enrolled patients in the study, 218 patients (42.7%) dropped out. With alfuzosin, IPSS and bother score significantly improved from baseline by -6.7±6.4 (-31.9%, p<0.001) and -1.2±1.2 (-29.3%, p<0.001), respectively. Nocturia also significantly improved from 2.3±1.3 at baseline to 1.8±1.0 at end-point (-0.6±1.1, p<0.001). In the subgroup of patients likely to be obstructed (Qmax <10 ml/sec at baseline), Qmax improved from 8.3±1.2 at baseline to 13.7±6.1 at end-point (+5.4±5.8, p=0.001). In patients with pain/discomfort on ejaculation, weighted score significantly improved from 2.4±2.2 at baseline to 1.5±1.9 at end-point (-31%, p=0.002). There were no clinically relevant changes in sitting systolic BP and diastolic BP at endpoint.

Conclusions

Alfuzosin 10 mg once daily administered for 6-months is effective in improving LUTS and quality of life, and is well tolerated from a sexual and cardiovascular perspective, including in elderly men and those receiving anti-hypertensive co-medication.

Keywords: Prostatic hyperplasia, Alfuzosin

Figures and Tables

Fig. 1
The improvement of lower urinary tract symptoms (LUTS) following treatment with alfuzosin 10 mg once daily. IPSS: International Prostate Symptom Score (observed case at each visit). a: p<0.001 vs. baseline, b: p<0.05 vs. M3.
kju-50-333-g001
Fig. 2
The improvement of weighted score following treatment with alfuzosin 10 mg once daily. DAN-PSS weighted item: Danish Prostate Symptom Score (observed case at each visit). a: p<0.05 vs. baseline, b: p<0.05 vs. M3.
kju-50-333-g002
Fig. 3
Comparison of changes in blood pressure by sub-groups. a: p>0.05 vs. baseline, b: p>0.05 vs. not treated group, c: p>0.05 vs. ≥65 years old group.
kju-50-333-g003
Table 1
Demographic and other baseline characteristics (n=511)
kju-50-333-i001

SBP: systolic blood pressure, DBP: diastolic blood pressure, LUTS: lower urinary tract symptoms, QoL: quality of life

Table 2
Changes in IPSS, QoL, Qmax, heart rate and blood pressure from baseline to endpoint (Mean±SD)
kju-50-333-i002

IPSS: International Prostate Symptom Score, QoL: quality of life, Qmax: maximun flow rate, bpm: beat per minute, SBP: systolic blood pressure, DBP: diastolic blood pressure, a: p<0.05 vs. baseline

Table 3
Frequency of adverse events under exposure to alfuzosin 10 mg (n=480)
kju-50-333-i003

AE: adverse events, NOS: not organ specific

Table 4
Comparison of changes in heart rate, blood pressure between hypertensive and normotensive group (Mean±SD)
kju-50-333-i004

bpm: beat per minute, SBP: systolic blood pressure, DBP: diastolic blood pressure, a: p>0.05 vs. baseline

ACKNOWLEDGEMENTS

The following investigators participated in the Alfuzosin study group: Se Joong Kim (Ajou University College of Medicine), Chun Il Kim (Keimyung University College of Medicine), Chul Sung Kim (Chosun University College of Medicine), Choung Soo Kim (Ulsan University College of Medicine), Choong Hee Noh (Inje University College of Medicine), Woo Chul Moon (Chung-Ang University College of Medicine), Choal Hee Park (Keimyung University College of Medicine), Soo Bang Ryu (Chonnam National University College of Medicine), Hwan Cheol Son (Seoul National University College of Medicine), Jae Mann Song (Yonsei University Wonju College of Medicine), Sang Eun Lee (Seoul National University College of Medicine), Jeong Gu Lee (Korea University Collegeof Medicine), Hyuk Soo Chang (Keimyung University College of Medicine), Young Beom Jeong (Chonbuk National University College of Medicine), Hee Chang Jung (Yeungnam University College of Medicine).

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