Efficacy and Safety of Sustained- Release Alfuzosin 5 mg in Patients with Benign Prostatic Hyperplasia

Objectives: To investigate (a) the magnitude and durability of symptom score reduction and HRQL score improvement (including sexual drive); (b) adverse outcomes; and (c) progression to acute urinary retention and prostate surgery up to three years of treatment with alfuzosin.Methods: Three thousand two hundred and twenty-eight BPH-patients out of 812 centers were included in a prospective three-year open-labelled study and treated with alfuzosin (immediate release formulation) at the recommended dosage. A symptom score (Boyarsky modi®ed) and a 20-item BPH speci®c HRQL score including three questions of sexuality (Urolife TM BPH QoL 20) were selfadministered at baseline, 3,6,12,18,24,30, and 36 months.Results: Two thousand ®ve hundred and seventy-nine patients (79.9%) completed the study at the end of three years. Symptom score was signi®cantly reduced by 54% at 3 months and this reduction was maintained up to 36 months (748.4%); HRQL score was signi®cantly improved by 45.4% at 12 months and this improvement was maintained up to 36 months ( 43.4%). Alfuzosin was well tolerated: the quantitative and qualitative distribution of adverse events was similar to that previously observed in placebo-controlled studies (vertigo/dizziness: 2.1%). Adverse events accounted for 4.2% of the drop-outs. 120 patients (3.7%) were operated on for BPH and nine patients (0.3%) experienced acute urinary retention.Conclusion: This medical outcomes study con®rms the long-term safety pro®le of alfuzosin in the naturalistic conditions of general practice and highlights the need to measure HRQL in the context of patient's preferences.

Section: Discussionsupporting

confidence: 80%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Three-year prospective study of 3228 clinical BPH patients treated with alfuzosin in General Practice

Lukacs

Grange

Comet

et al. 1998

“…Terazosin also reduces detrusor sphincter dyssynergia in patients with bladder neck contracture, possibly via a central effect. 74 63 Buzelin et al (1997) 64 Lepor et al (1996) 67 Brawer et al (1993) 66 …”

Section: Comparative Ef®cacy Of the Current Agentsmentioning

confidence: 99%

α1-Adrenoceptor selectivity and the treatment of benign prostatic hyperplasia and lower urinary tract symptoms

Kirby

Lepor

et al. 2000

The storage (irritative) and voiding (obstructive) symptoms associated with benign prostatic hyperplasia are generally attributed to prostate enlargement and increased prostatic smooth muscle tone mediated by the prevailing a 1 -adrenoceptors in the bladder neck and prostate. This results in obstruction and subsequent secondary changes to the bladder. However, there is growing evidence that many of these symptoms may be due to changes in extraprostatic a 1 -adrenoceptors, possibly a 1D -adrenoceptors. Findings from the VA cooperative trial challenge the current theory that the common side effects associated with these agents are due to vascular action of a 1 -adrenoceptor blockers. Prostate Cancer and Prostatic Diseases (2000) 3, 76±83.

“…The other major medical option, 5a-reductase inhibitors, can produce improve- Table 2 Reasons why men with symptoms of prostatic disease do not present to their doctor 20 Perception that symptoms are a normal feature of ageing Fear of a diagnosis of cancer Fear of surgery and its potential side effects Reluctance to discuss symptoms with a female family practitioner Fear of ridicule and embarrassment of discussing symptoms Dislike of digital rectal examination and other tests Reluctance to leave the home for diagnosis and treatment ment in symptoms (20 ± 30%) and maximum¯ow rate (20%); 23,24 the effects are greater in men with prostates greater than 40 mL. 25 a 1 -Blockers have a clear advantage in that they are faster acting, with effects frequently being observed within the ®rst two to three weeks of treatment 26 compared with at least three to six months with 5a-reductase inhibitors. 23,24 As a result of these advantages, a 1 -blockers are recommended as a ®rst-line therapy for many BPH sufferers.…”

Section: What Can Be Done?mentioning

confidence: 99%

The prostate, men and men's health

Kirby

1999

Benign prostatic hyperplasia (BPH) is the most prevalent disease in the ageing male and the incidence of symptomatic disease is likely to increase in the millenium with increased life expectancy. BPH can have a severe impact on quality of life, including sexual function, and yet many men do not seek medical attention for this and many other diseases. Surgery is no longer a mandatory treatment for BPH. Medical management can provide excellent symptom relief and improvement in urinary¯ow rates, as well as quality of life, and men need to be made aware of this in order to make informed treatment decisions. In the broader context, men should be encouraged to become more health conscious and develop a more positive attitude towards their health.Keywords: benign prostatic hyperplasia; men's health Prevalence of BPHBenign prostatic hyperplasia (BPH) is the most prevalent disease among men beyond middle age. Autopsy studies show that histological BPH is present in 50% of men in their 60s, rising to 90% in men b 85 years of age. 1 The proportion of men with palpable prostatic enlargement is rather less, with a prevalence of 21% in men aged 50 ± 60 y and 53% in men in their 80s. More important is the proportion of men actually troubled by the lower urinary tract symptoms (LUTS) associated with BPH. Results show that, again, the incidence of these symptoms increases with age (Table 1). 2 ± 6 Worldwide, there is a pronounced shift towards an increasingly aged society, and as a result, more patients will be diagnosed with BPH and require treatment. By the year 2000, male life expectancy will exceed 80 y in many countries, and the majority of men can therefore be expected to have an 88% chance of developing histological BPH and a 50% chance of developing symptomatic BPH. Effect of BPH on quality of lifeAlthough BPH is a common disease which is rarely lifethreatening, it can result in signi®cant impairment in the patient's quality of life. A study by Garraway and associates 7 indicates that about half of the men with evidence of obstructive BPH (de®ned as a prostate on transrectal ultrasonography b 20 g, and symptoms of urinary dysfunction and/or a peak urine¯ow rate of`15 mL/s) reported interference with one or more activities of daily living, compared with 28% of men without the condition. 7 In addition to this impairment in quality of life, many patients reported worry and embarrassment about their urinary function. 8 A recent study shows that sexual dysfunction is increased in men with LUTS associated with BPH. Sexual expression was affected by 45% of men reporting such symptoms to a urology clinic in one of 12 countries and by 7% of community-dwelling men aged 40 y and over. 9 In this and other ways, BPH can impact not only on the man but also on his partner.A number of speci®c questionnaires have been developed to assess the impact on quality of life of BPH and its treatment. One long-term study by Lukacs and coworkers 10 involving 7093 patients in general practice used a self-administered questionnaire, which measured...