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 Lee, Cheol Young Oh, Byungha Chung, Se Joong Kim, Chun Il Kim, Chul Sung Kim, Choung Soo Kim, Choong Hee Noh, Woo Chul Moon, Choal Hee Park, Soo Bang Ryu, Hwan Cheol Son, Jae Mann Song, Sang Eun Lee, Jeong Gu Lee, Hyuk Soo Chang, Young Beom Jeong, Hee Chang Jung

Research output: Contribution to journalArticle

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, non-comparative, 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.

Original languageEnglish
Pages (from-to)333-339
Number of pages7
JournalKorean Journal of Urology
Volume50
Issue number4
DOIs
Publication statusPublished - 2009 Apr 1

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Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Safety
Prostate
Nocturia
Ejaculation
Korea
Antihypertensive Agents
Observational Studies
alfuzosin
Quality of Life
Pain
Population

All Science Journal Classification (ASJC) codes

  • Urology

Cite this

Lee, Seung Wook ; Lee, Seung Hwan ; Oh, Cheol Young ; Chung, Byungha ; Kim, Se Joong ; Kim, Chun Il ; Kim, Chul Sung ; Kim, Choung Soo ; Noh, Choong Hee ; Moon, Woo Chul ; Park, Choal Hee ; Ryu, Soo Bang ; Son, Hwan Cheol ; Song, Jae Mann ; Lee, Sang Eun ; Lee, Jeong Gu ; Chang, Hyuk Soo ; Jeong, Young Beom ; Jung, Hee Chang. / 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. In: Korean Journal of Urology. 2009 ; Vol. 50, No. 4. pp. 333-339.
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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, non-comparative, 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.",
author = "Lee, {Seung Wook} and Lee, {Seung Hwan} and Oh, {Cheol Young} and Byungha Chung and Kim, {Se Joong} and Kim, {Chun Il} and Kim, {Chul Sung} and Kim, {Choung Soo} and Noh, {Choong Hee} and Moon, {Woo Chul} and Park, {Choal Hee} and Ryu, {Soo Bang} and Son, {Hwan Cheol} and Song, {Jae Mann} and Lee, {Sang Eun} and Lee, {Jeong Gu} and Chang, {Hyuk Soo} and Jeong, {Young Beom} and Jung, {Hee Chang}",
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doi = "10.4111/kju.2009.50.4.333",
language = "English",
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Lee, SW, Lee, SH, Oh, CY, Chung, B, Kim, SJ, Kim, CI, Kim, CS, Kim, CS, Noh, CH, Moon, WC, Park, CH, Ryu, SB, Son, HC, Song, JM, Lee, SE, Lee, JG, Chang, HS, Jeong, YB & Jung, HC 2009, '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', Korean Journal of Urology, vol. 50, no. 4, pp. 333-339. 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. / Lee, Seung Wook; Lee, Seung Hwan; Oh, Cheol Young; Chung, Byungha; Kim, Se Joong; Kim, Chun Il; Kim, Chul Sung; Kim, Choung Soo; Noh, Choong Hee; Moon, Woo Chul; Park, Choal Hee; Ryu, Soo Bang; Son, Hwan Cheol; Song, Jae Mann; Lee, Sang Eun; Lee, Jeong Gu; Chang, Hyuk Soo; Jeong, Young Beom; Jung, Hee Chang.

In: Korean Journal of Urology, Vol. 50, No. 4, 01.04.2009, p. 333-339.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of Alfuzosin 10 mg once daily in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia

T2 - A 6-months study in real life practice

AU - Lee, Seung Wook

AU - Lee, Seung Hwan

AU - Oh, Cheol Young

AU - Chung, Byungha

AU - Kim, Se Joong

AU - Kim, Chun Il

AU - Kim, Chul Sung

AU - Kim, Choung Soo

AU - Noh, Choong Hee

AU - Moon, Woo Chul

AU - Park, Choal Hee

AU - Ryu, Soo Bang

AU - Son, Hwan Cheol

AU - Song, Jae Mann

AU - Lee, Sang Eun

AU - Lee, Jeong Gu

AU - Chang, Hyuk Soo

AU - Jeong, Young Beom

AU - Jung, Hee Chang

PY - 2009/4/1

Y1 - 2009/4/1

N2 - 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, non-comparative, 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.

AB - 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, non-comparative, 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.

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