my personal edition > genitourinary other > news


  E-Mail this DGDispatch to a colleague

DGDispatch

Alfuzosin Reduces Lower Urinary Tract Symptoms in Men: Presented at EAU

By Chris Berrie

BERLIN, GERMANY -- March 27, 2007 -- The new agent alfuzosin is effective in treating lower urinary tract symptoms (LUTS) `suggestive of benign prostatic hyperplasia (BPH) in real life practice regardless of patient age and prostate-specific antigen (PSA) levels, according to an international, multicentre, open-label study.

One of the more recent additions to the alpha1-adrenoceptor antagonist drug class, alfuzosin is now used in the treatment of BPH. Therefore, this study was designed to assess the effects of alfuzosin (10 mg, once daily) in a real-life setting.

Mark Emberton, MD, steering committee member and consultant in urology, department of urology, University College London, London, United States, presented the study here at the 22^nd Annual Congress of the European Association of Urology (EAU) on behalf of the Alf-One Study Group.

In this 6-month open-label study of alfuzosin, 6,574 men presenting with LUTS were enrolled by GPs and urologists. The cohort's mean age was 64.5 years. LUTS were evaluated using the International Prostate Symptom Score (IPSS), bother and nocturia.

With the age quartiles of <60, 60-64, 65-70 and >70 years, there were no significant differences in baseline mean IPSS according to age (range, 17.2-17.7). However, these age quartiles did show differences according to bother score >3 (range with increasing age, 70%-60%; global P < .0001); mean nocturia (range with increasing age, 2.4-2.9; global P < .001); and percent with nocturia >3/night (range with increasing age, 19%-29%; global P < .001).

After 6 months with alfuzosin 10 mg/day, the IPSS within each age quartile showed significant decreases of approximately 7 points (P < .001), with no significant differences according to age group. Similarly, the percent of patients with a bother score >3 showed a consistent decrease of about 50% within each age quartile (P < .001), with no age-related trends.

However, for both mean nocturia and percent of patients with nocturia score >3, there were consistent decreases within each age group (0.9, 13.5-19, respectively), thus paralleling the significant baseline changes (global P < .001 for both).

Again, with the PSA tertiles of <1.4, 1.4-3.2, >3.2 ng/mL, while both IPSS and bother score showed significant reductions from baseline (range, 6.9-7.7; range, 1.4-1.6; respectively; P < .001), these improvements were not related to the PSA tertiles.

Over the 6-month treatment period, the 3 main BPH progression events were worsening of IPSS by 4 or more points, BPH-related surgery, and acute urinary retention (AUR) (4.8%, 1.4%, 0.6%, respectively). Again, this IPSS measure was unrelated to the baseline PSA tertiles, while AUR and BPH-related surgery were related to baseline PSA tertiles (P = .004, P = .003, respectively). However, IPSS worsening by 4 or more points was strongly predictive of both AUR and BPH-related surgery (P < .0001 for both).

Among the 7,462 evaluated for safety parameters, there was a 7.2% drop out rate due to adverse events, with adverse events being mainly vasodilatatory-related. These were dizziness/postural dizziness (4.9%), hypotension/postural hypotension (0.9%), headache (2.5%), malaise (0.2%) and syncope (0.3%). Low levels of asthenia/fatigue (1.9%) and erectile dysfunction (1.0%) were also recorded. None of these showed any relationship to age.

In his presentation on March 22^nd, Dr. Emberton concluded that alfuzosin 10 mg/day is effective in reducing LUTS, including nocturia, regardless of the patient's prostate size. The agent is also well tolerated, irrespective of age, and associated with a low incidence of BPH progression events.

The study was supported by Sanofi.


[Study title: Alfuzosin 10 mg Once Daily Is Effective on LUTS and Nocturia and Shows a Low Incidence of BHP Progression Events, Even in Enlarged Prostates. Abstract 348]

E-Mail this DGDispatch to a colleague

To print, use this version