Objective: The aim of this study was to assess the impact of a 12–month treatment period with alfuzosin, 2.5 mg t.i.d, on symptomatic patients with BPH (n = 355) by means of the International Prostate Symptom Score (I–PSS), the Symptom Problem Index (SPI), the BPH Impact Index (BII), and the single Quality of Life (QoL) question proposed by the WHO.Study Design: This was a naturalistic study, carried out under conditions of normal practice by 22 centres of urology.Methods: At baseline and on a quarterly basis up to 12 months of treatment, subjective and objective (uroflowmetry and residual urine volume) responses of the patients were evaluated. The appearance of adverse medical events (AMEs) was carefully monitored and recorded throughout the trial.Results: Both the BII and the Qol question improved gradually over time (60 and 54.6%, respectively, after 12 months of treatment). At any visits, the improvements were statistically significant versus the baseline (p<0.01). Alfuzosin was able to improve the BPH symptoms progressively and significantly over time: total mean score I–PSS: 3rd month = 22.7%, 6th month = 38.4%, 9th month 0.50%, 12th month = 61.6%. The improvement was more marked in patients with severe symptoms at baseline (I–PSS score 20–35, 63.6%). A progressive and marked improvement over time of the problems due to symptoms (SPI) was observed in the whole population (61.7% after 12 months of treatment). After 12 months of treatment, uroflowmetric data showed a significant increase in peak (+5.5 ml/s) flow rate, associated with a marked decrease in residual volume: –31 ml (–53.5%). Twenty–five patients (7.1%) experienced one or more AMEs (total AMEs n = 44). Globally, 14 vasodilatory events and 30 non–vasodilatory events were reported. Fifteen (4.3%) patients dropped out prematurely from the study for safety reasons. Seven serious AMEs were reported during the study period.Conclusions: This study showed that long–term treatment with alfuzosin in usual clinical practice had a continued and positive impact on the patients’ QoL.

1.
Berry SJ, Coffey DS, Walsh PC, Ewing LL: The development of human prostatic hyperplasia with age. J Urol 1984;132:474–479.
2.
Cockett ATK, Khoury S, Aso Y, Chatelain C, Denis L, Griffiths K, Murphy O: Proceedings of the 3rd International Consultation on Benign Prostatic Hyperplasia (BPH). Channel Islands, Scientific Communication International Ltd, 1995, pp 123–166.
3.
Department of Health and Human Service: Benign prostatic hyperplasia: Diagnosis and treatment. AHCPR Publication, 1994, No 94– 0582.
4.
Oesterling JE: Drug therapy: Benign prostatic hyperplasia. Medical and minimally invasive treatment option. N Engl J Med 1995;332:99– 109.
5.
Caine M: The present role of alpha–adrenergic blockers in the treatment of benign prostatic hypertrophy. J Urol 1986;136:1–4.
6.
Shapiro E, Becich MJ, Hartanto V, Lepor H: The relative proportion of stromal and epithelial hyperplasia is related to the development of symptomatic benign prostate hyperplasia. J Urol 1992;147:1293–1297.
7.
Raezer DM, Wein AJ, Jacobowitz DJ, Corriere JN: Autonomic innervation of canine urinary bladder. Urology 1973;2:211–221.
8.
Hieble JP, Caine M, Zalaznik E: In vitro characterization of the α–adrenoceptors in human prostate. Eur J Pharmacol 1985;107:111–117.
9.
Caine M, Raz S, Zeigler M: Adrenergic and cholinergic receptors in the human prostate, prostatic capsule and bladder neck. Br J Urol 1975;47:193–202.
10.
Kirby RS, Coppinger SWC, Corcoran MO, Chapple CR, Flannigan M, Milroy EJG: Prazosin in the treatment of prostatic obstruction. A placeob controlled study. Br J Urol 1987;60: 136–142.
11.
Iacovou JW, Dunn M: Indoramin: An effective new drug in the management of bladder outflow obstruction. Br J Urol 1987;60:526–528.
12.
Gerstenberg T, Blaabjerg J, Nielsen ML, Olausen S: Phenoxybenzamine reduces bladder outlet obstruction in benign prostatic hyperplasia. An urodynamic investigation. Invest Urol 1980;18:29–31.
13.
Caine M, Pelberg S, Shapiro A: Phenoxybenzamine for benign prostatic hypertrophy. Review of 200 cases. Urology 1981;17:542–546.
14.
Abrams PH, Shah PLR, Stone R, Choa RG: Bladder outflow obstruction treated with phenoxybenzamine. Br J Urol 1982;54:527–530.
15.
Martorana G, Giberti C, Damonte P, Ciprandi G, Dirienzo W, Giuliani L: The effect of prazosin in benign prostatic obstruction. A placebo–controlled double–blind study. IRCS Med Sci 1984;12:11–12.
16.
Stott MA, Abrams PH: Indoramin in benign prostatic hypertrophy. A placebo controlled trial. J Urol 1989;139:464A.
17.
Dunzendorfer U: Clinical experience: Symptomatic management of BPH with terazosin. Urology 1988;37(suppl):27–30.
18.
Lepor H, Williford WO, Barry MJ, et al: The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. N Engl J Med 1996;335:533–539.
19.
Debruyne FMJ, Jardin A, Colloi D, Resel L, Witjes WPJ, Delauche–Cavallier MC, McCarthy C, Geffriaud–Ricouard C: Sustained–release alfuzosin, finasteride and the combination of both in the treatment of benign prostatic hyperplasia. Eur Urol 1998;34:169–175.
20.
Lefèvre–Borg F, O’Connor SE, Schoemaker H, Hicks PE, Lechaire J, Gautier E, Pierre F, Pimoule C, Manoury P, Langer SZ: Alfuzosin, a selective α1–adrenoceptor antagonist in the lower urinary tract. Br J Pharmacol 1993;109: 1282–1289.
21.
Wilde MI, Fitton A, McTavish D: Alfuzosin: A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in benign prostatic hyperplasia. Drugs 1993; 45:410–429.
22.
Jardin A, Bensadoun H, Delauche–Cavallier MC, Attali P, the BPHALF Group: Alfuzosin for treatment of benign prostatic hypertrophy. Lancet 1991;337:1457–1461.
23.
Jardin A, Bensadoun H, Delauche–Cavallier MC, Attali P, the BPHALF Group: Long–term treatment of benign prostatic hyperplasia with alfuzosin: A 12–18 month assessment. Br J Urol 1993;72:615–620.
24.
Jardin A, Bensadoun H, Delauche–Cavallier MC, Stalla–Bourdillon A, Attali P, the BPHALF Group: Long–term treatment of benign prostatic hyperplasia with alfuzosin: A 24–30 month survey. Br J Urol 1994;74: 579–584.
25.
The Italian Alfuzosin Co–Operative Group: Multicentric observational trial on symptomatic treatment of benign prostatic hyperplasia with alfuzosin: Clinical evaluation of impact on patient’s quality of life. Eur Urol 1995;27: 128–134.
26.
Lukacs B, McCarthy C, Grange JC, the QoL BPH Study Group in General Practice: Long–term quality of life in patients with benign prostatic hypertrophy: Preliminary results of a cohort survey of 7,093 patients treated with an alpha–1–adrenergic blocker, alfuzosin. Eur Urol 1993;(suppl 1):34–40.
27.
Syroky MB, Olsson CA, Krane RJ: The flow rate monogram. I. Development. J Urol 1979; 122:665–668.
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.