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Lee, Lee, Choe, Shin, and Cho: Safety and Efficacy of BearxatⓇXL Tablet (alfuzosin 10 mg) in Patients with Benign Prostatic Hyperplasia: A Prospective Multicenter Study of Primary Care Clinics
Original Article

Korean J Androl 2012;30(1):71-79.

Published online: 17 April 2012

DOI: https://doi.org/10.5534/kja.2012.30.1.71

Safety and Efficacy of BearxatⓇXL Tablet (alfuzosin 10 mg) in Patients with Benign Prostatic Hyperplasia: A Prospective Multicenter Study of Primary Care Clinics

Seung-Ju Lee1, Dong Sup Lee1, Hyun-Sop Choe1, Myung Sik Shin2, Yong-Hyun Cho1,

1Department of Urology, The Catholic University of Korea, College of Medicine, Seoul, Korea

2Myung Urology Clinic, Bchenon, Korea

교신저자: 조용현, 가톨릭대학교 의과대학 여의도성모병원 비뇨기과, 서울시 영등포구 여의도동 62 150-713 Tel: 02-3779-1227, Fax: 02-761-1626, E-mail: cyh0831@catholic.ac.kr

∗ This study was financially supported by Daewoong Co., Ltd.

      Revised 21 December 201127 February 20121 April 2012       Accepted 2 April 2012

Copyright © 2012 Journal of the Korean Society for Male Gynecology

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

A prospective multicenter study was conducted to evaluate the safety and efficacy of alfuzosin (10 mg), for male lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in primary care clinics.

Conclusions

Treatment with alfuzosin (10 mg) once daily led to significant improvements in LUTS associated with BPH and QoL in primary care clinic patients. alfuzosin (10 mg) use resulted in few hypotensive events, no deleterious effect on sexual function, and no drug related SAEs during the study. The study findings suggest that alfuzosin (10 mg) can be safely prescribed in primary care clinics for male LUTS with efficacy.

Materials and Methods

Three hundred twenty-four patients with complaints of LUTS associated with BPH were enrolled from 17 clinics. Patients received a 12-week course of 10 mg alfuzosin (Bearxat®XL Tablet) once daily, and underwent followup at 2∼4 and 12 weeks posttreatment. The maximum flow rate (Qmax) and residual urine volume (RUV) were measured at each visit. The International Prostate Symptom Score (IPSS), Quality of Life (QoL), and International Index of Erectile Function (IIEF-5) were evaluated at baseline and posttreatment. During the study period, the presence of orthostatic hypotension was evaluated by blood pressure measurement before and after a postural change. Any adverse effects of alfuzosin including retrograde ejaculation were assessed.

Results

Of the 324 enrolled patients, 62 (19.1%) patients dropped out and a total of 262 patients were evaluated. Each value of Qmax, RUV, IPSS, QoL, and IIEF-5 was significantly improved from 14.19±8.85 ml/sec, 41.10±81.44 ml, 18.04±7.36, 3.81±0.86, and 11.75±6.91, respectively, at baseline, to 15.68±6.25 ml/sec, 24.29±29.46 ml, 12.19±5.59, 2.54±0.91, and 12.33±7.55, respectively, at end-point. Retrograde ejaculation was found in 2 patients (2/255, 0.78%) at 2∼4 weeks and 1 patient (1/152, 0.66%) at 12 weeks. The frequency of orthostatic hypotension was 13.27% (30/226) at baseline, 13.11% (27/206, p=0.8658) at 2∼4 weeks, and 14.29% (19/133, p=0.8348) at end-point. The number of patients with adverse events was 36 where the number of adverse events was 60. Among those 60 adverse events, 8 events were related to treatment, which consisted of headache (2), dizziness (2), palpitation (1), voiding difficulty (1), erectile dysfunction (1), and arthralgia (1).

Keywords: Prostatic hyperplasia, alfuzosin, Adverse effects

REFERENCES

1). Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984; 132:474–9.
crossref
2). Fine SR, Ginsberg P. Alpha-adrenergic receptor antagonists in older patients with benign prostatic hyperplasia: issues and potential complications. J Am Osteopath Assoc. 2008; 108:333–7.
3). Hellstrom WJ, Sikka SC. Effects of acute treatment with tamsulosin versus alfuzosin on ejaculatory function in normal volunteers. J Urol. 2006; 176:1529–33.
crossref
4). Yoshida M, Kudoh J, Homma Y, Kawabe K. Safety and efficacy of silodosin for the treatment of benign prostatic hyperplasia. Clin Interv Aging. 2011; 6:161–72.
crossref
5). Moon DG, Bae YD, Lee SW, Moon KH, Ahn TY, Jeong WS, et al. The efficacy and safety of tamsulosin 0.2mg/day on sexual function in BPH: a multicenter open-label, non-comparative, 3 months ob-servational, phase IV prospective study. Korean J Androl. 2009; 27:123–9.
6). Spilker B. Guide to clinical trials. New York: Raven Press;1991. p. 71–83.
7). Lepor H, Gup DI, Baumann M, Shapiro E. Laboratory assessment of terazosin and alpha-1 blockade in prostatic hyperplasia. Urology. 1988; 32:21–6.
8). MacDonald R, Wilt TJ. Alfuzosin for treatment of lower urinary tract symptoms compatible with benign prostatic hyperplasia: a systematic review of efficacy and adverse effects. Urology. 2005; 66:780–8.
crossref
9). Gillenwater JY, Conn RL, Chrysant SG, Roy J, Gaffney M, Ice K, et al. Doxazosin for the treatment of benign prostatic hyperplasia in patients with mild to moderate essential hypertension: a double-blind, placebo-controlled, dose-response multicenter study. J Urol. 1995; 154:110–5.
crossref
10). Low PA. Prevalence of orthostatic hypotension. Clin Auton Res. 2008; 18:8–13.
crossref
11). Poon IO, Braun U. High prevalence of orthostatic hypotension and its correlation with potentially causative medications among elderly veterans. J Clin Pharm Ther. 2005; 30:173–8.
crossref
12). Lukacs B, Blondin P, MacCarthy C, Du Boys B, Grippon P, Lassale C. Safety profile of 3 months' therapy with alfuzosin in 13,389 patients suffering from benign prostatic hypertrophy. Eur Urol. 1996; 29:29–35.
13). Lepor H. Longterm evaluation of tamsulosin in benign prostatic hyperplasia: placebo-controlled, double-blind extension of phase III trial. Tamsulosin Investigator Group. Urology. 1998; 51:901–6.
14). Lee SW, Lee SH, Oh CY, Chung BH. 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 J Urol. 2009; 50:333–339.
crossref
15). Roehrborn CG, Van Kerrebroeck P, Nordling J. Safety and efficacy of alfuzosin 10 mg once-daily in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies. BJU Int. 2003; 92:257–61.
crossref
16). Chung BH, Lee JY, Kim CI, Kim CS, Oh CY, Lee SW, et al. Sexuality and the management of BPH with alfuzosin (SAMBA) trial. Int J Impot Res. 2009; 21:68–73.
crossref
17). Kaplan SA. Side effects of alpha-blocker use: retrograde ejaculation. Rev Urol. 2009; 11:S14–8.
18). Bourke JB, Griffin JP. Hypertension, diabetes mellitus, and blood groups in benign prostatic hypertrophy. Br J Urol. 1966; 38:18–23.
crossref
19). Santillo VM, Lowe FC. Treatment of benign prostatic hyperplasia in patients with cardiovascular disease. Drugs Aging. 2006; 23:795–805.
crossref

Table 1.
Changes in each parameter following treatment with 10 mg alfuzosin once a day
  Qmax(ml/sec) RUV(ml) IPSS QoL IIEF-5
Baseline 14.19±8.85 41.10±81.44 18.04±7.36 3.81±0.86 11.75±6.91
12.00 [7.75] 20.00 [40.00] 17.00 [11.00] 4.00 [1.00] 12.00 [11.00]
(n=233) (n=232) (n=259) (n=258) (n=258)
12 weeks 15.68±6.25 24.29±29.46 12.19±5.59 2.54±0.91 12.33±7.55
15.00 [6.00] 10.00 [36.00] 12.00 [7.00] 2.00 [1.00] 14.00 [13.00]
(n=118) (n=105) (n=134) (n=134) (n=132)
12 W-baseline 1.11±7.37 −18.34±32.66 −6.14±5.39 −1.32±0.94 0.46±3.16
2.60 [5.60] −10.00 [24.50] −6.00 [6.00] −1.00 [1.00] 0.00 [2.00]
(n=117) (n=103) (n=134) (n=134) (n=132)
p-value 0.0007 ＜0.0001 ＜0.0001 ＜0.0001 0.0024

p-value from Wilcoxon signed rank test. Data were expressed by mean±standard deviation and median [interquartile range, IQR] Qmax: maximum flow rate, RUV: residual urine volume, IPSS: International Prostate Symptom Score, QoL: quality of life, IIEF: International Index of Erectile Function.

Table 2.
Incidence of orthostatic hypotension
  Alfuzosin treatment
Baseline After 2∼4 weeks, n (%) After 12 weeks, n (%)
  Yes No Total Yes No Total
Yes 10 (4.85) 18 (8.74) 28 8 (6.02) 12 (9.02) 20
No 17 (8.25) 161 (78.16) 178 11 (8.27) 102 (76.69) 113
Total 27 179 206 19 114 133
p-value   0.8658     0.8348  

p-value from McNemar's test.

Table 3.
Report of adverse events
  N=262
  No. of events (%) No. of events related to treatment (%)
System organ class/ preferred term N (%) N (%)
Number of subjects with AE (s) 36 (13.74) 6 (2.29)
Dermatological disorders 11 (4.20) 0 (0.00)
 Contact dermatitis 7 (2.67) 0 (0.00)
 Pruritus 5 (1.91) 0 (0.00)
 Trichophytosis 3 (1.15) 0 (0.00)
 Psoriasis 2 (0.76) 0 (0.00)
 Tinea pedis 2 (0.76) 0 (0.00)
 Rash 1 (0.38) 0 (0.00)
 Furuncle 1 (0.38) 0 (0.00)
 Pruritus ani 1 (0.38) 0 (0.00)
 Other 1 (0.38) 0 (0.00)
Urological disorders 9 (3.44) 1 (0.38)
 Urogenital infection 4 (1.53) 0 (0.00)
 Frequency 2 (0.76) 0 (0.00)
 Overactive bladder 1 (0.38) 0 (0.00)
 Voiding difficulty 1 (0.38) 1 (0.38)
 Dysuria 1 (0.38) 0 (0.00)
 Nocturia 1 (0.38) 0 (0.00)
 Others 1 (0.38) 0 (0.00)
Neurological disorders 7 (2.67) 3 (1.15)
 Headache 6 (2.29) 2 (0.76)
 Dizziness 2 (0.76) 2 (0.76)
Reproductive disorders 6 (2.29) 0 (0.00)
 Prostatitis 2 (0.76) 0 (0.00)
 Orchitis 1 (0.38) 0 (0.00)
 Perineal discomfort 1 (0.38) 0 (0.00)
 Epididymitis 1 (0.38) 0 (0.00)
 Prostate hyperplasia 1 (0.38) 0 (0.00)
Gastrointestinal disorders 4 (1.53) 0 (0.00)
 Abdominal pain 1 (0.38) 0 (0.00)
 Epigastric pain 1 (0.38) 0 (0.00)
 Diarrhea 1 (0.38) 0 (0.00)
 Dyspepsia 1 (0.38) 0 (0.00)
Neuropsychologic disorders 4 (1.53) 1 (0.38)
 Erectile dysfunction 3 (1.15) 1 (0.38)
 Drowsiness 1 (0.38) 0 (0.00)
Musculoskeletal disorders 1 (0.38) 1 (0.38)
 Arthralgia 1 (0.38) 1 (0.38)
 Neoplasia 1 (0.38) 0 (0.00)
 Prostate cancer 1 (0.38) 0 (0.00)
Cardiovascular disorders 1 (0.38) 1 (0.38)
 Palpitation 1 (0.38) 1 (0.38)
Respiratory disorders 1 (0.38) 0 (0.00)
 Cough 1 (0.38) 0 (0.00)

AE: adverse events.

Table 4.
Incidence of adverse events related to cardiovascular disease
Cardiovascular disease AE ＋
 AE −
 Total
 p-value∗
n (N) (%) n (N) (%) n (N) (%)
Yes 5 (66) 7.58 61 (66) 92.42 66 (262) 25.19  
No 31 (196) 15.82 165 (196) 84.18 196 (262) 74.81 0.0926
Total 36 (262) 13.74 226 (262) 86.26 262 (262) 100.00  

∗ p-value from chi-square test. n: number of patients with adverse events, N: number of patients with or without cardiovascular disease.

Table 5.
Incidence of adverse events related to concomitant antihypertensive treatment
Antihypertensive AE ＋
 AE −
 Total
 p-value∗
n (N) (%) n (N) (%) n(N) (%)
Yes 3(21) 14.29 18(21) 85.71 21(262) 8.02  
No 33(241) 13.69 208(241) 86.31 241(262) 91.98 1.0000
Total 36(262) 13.74 226(262) 86.26 262(262) 100.00  

∗ p-value from Fisher's exact test. n: number of patients with adverse events, N: number of patients with or without antihypertensive drug.

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