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Claus G Roehrborn - One of the best experts on this subject based on the ideXlab platform.

  • effects of Alfuzosin 10 mg once daily on sexual function in men treated for symptomatic benign prostatic hyperplasia
    International Journal of Impotence Research, 2007
    Co-Authors: Raymond C Rosen, Allen D Seftel, Claus G Roehrborn
    Abstract:

    We evaluated the effects of extended-release Alfuzosin HCl 10 mg once daily (q.d.) on sexual function in men with lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). In a randomized, double-blind, placebo-controlled study of men aged > or = 50 years, after a 28-day placebo run-in period, patients were randomized to receive Alfuzosin 10 mg q.d. or matching placebo for 28 days. The mean change from baseline (day 1) in sexual function on day 29 was assessed using the Danish Prostate Symptom Score Sex (DAN-PSSsex) questionnaire. A total of 372 patients were randomized to receive Alfuzosin (n=186) or placebo (n=186), with 355 completing the study. At baseline, 64% of the patients reported erectile dysfunction (ED) and 63% reported ejaculatory dysfunction (EjD). For the 320 patients who completed the DAN-PSSsex, Alfuzosin treatment was associated with a significant improvement in the mean change from baseline in erectile function on day 29 compared with placebo (P=0.02). No significant difference was observed between the two treatment groups in the mean change from baseline in ejaculatory function on day 29. For patients with ED at baseline, a marginal improvement in erectile function was demonstrated with Alfuzosin treatment (P=0.09 vs placebo). For patients with EjD at baseline, the mean change from baseline in ejaculatory function with Alfuzosin was comparable to that with placebo. Dizziness was the most common adverse event with Alfuzosin treatment (5 vs 0% with placebo), with other adverse events reported with comparable frequency in both treatment groups. After 1 month of treatment, Alfuzosin 10 mg q.d. significantly improved erectile function in men with lower urinary tract symptoms/ benign prostatic hypertrophy and had no adverse effect on ejaculatory function.

  • three months treatment with the α1 blocker Alfuzosin does not affect total or transition zone volume of the prostate
    Prostate Cancer and Prostatic Diseases, 2006
    Co-Authors: Claus G Roehrborn
    Abstract:

    Treatment with α1-adrenergic receptor blockers improves lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia. This study was conducted to test the hypothesis that induction of apoptosis in prostate tissue could be a mechanism underlying the observed clinical benefit. This placebo-controlled, double-blind, randomized trial enrolled 536 men with LUTS who were treated with Alfuzosin (10 or 15 mg) once daily or placebo for 3 months. Total prostate and transition zone volume was measured by standardized transrectal ultrasound measurements at baseline and 3 months. Total prostate volume increased by 0.4 ml from baseline in placebo patients but decreased by −0.25 ml in the combined Alfuzosin groups. Percentage change was not statistically significantly different between the placebo and Alfuzosin groups. Changes in transition zone volumes from baseline were similar in both treatment arms; percentage change was not statistically significantly different between the placebo and Alfuzosin groups. Volume changes did not correlate with prostate volumes at baseline. Overall, neither total prostate nor transition zone volume increased or decreased systematically within the 3-month treatment period. If Alfuzosin-induced apoptosis in prostate tissue, it was not evident by a measurable change in prostate volume after 3 months’ treatment. Further analysis at 1 and 2 years will determine the effect of longer-term treatment.

  • Alfuzosin 10 mg once daily prevents overall clinical progression of benign prostatic hyperplasia but not acute urinary retention results of a 2 year placebo controlled study
    BJUI, 2006
    Co-Authors: Claus G Roehrborn
    Abstract:

    OBJECTIVES To evaluate the effect of Alfuzosin 10 mg once daily administered for 2 years on progression events in men with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH). PATIENTS AND METHODS In all, 1522 men at risk of having progression events from LUTS/BPH were randomized to receive Alfuzosin 10 mg once daily (759) or placebo (763) for 2 years. Endpoints assessed were the occurrence of a first episode of acute urinary retention (AUR; primary) and the need for BPH-related surgery. Post hoc analyses included a deterioration in the International Prostate Symptom Score (IPSS) of ≥ 4 points and overall clinical progression of BPH (occurrence of AUR and/or surgery and/or symptom deterioration). RESULTS Over 2 years, symptom deterioration was the most common progression event (14.3%), followed by BPH-related surgery (5.8%) and AUR (2.0%). Alfuzosin did not reduce the risk of AUR (Alfuzosin 2.1% vs placebo 1.8%, P = 0.82) but tended to reduce the risk of surgery (5.1% vs 6.5%, P = 0.18); the reduction in risk (RR) and 95% confidence interval with Alfuzosin was 22 (−18 to 48)%; and significantly reduced the risk of symptom deterioration (11.7% vs 16.8%; P = 0.0013); the RR was 30 (10–46)%. The overall clinical progression of BPH was significantly lower with Alfuzosin than with placebo (16.3% vs 22.1%, P < 0.001); RR 26 (9–40)%. Alfuzosin also significantly improved the IPSS (P = 0.017), quality of life (P < 0.001) and peak flow rate (P = 0.001) compared with placebo. Baseline levels of prostate-specific antigen (PSA) predicted both AUR and BPH-related surgery events, while the baseline postvoid residual urine volume predicted symptom deterioration. The incidence of adverse events with Alfuzosin was comparable to that with placebo. CONCLUSIONS Alfuzosin 10 mg once daily prevents the overall clinical progression of BPH, defined by the occurrence of a deterioration in IPSS of ≥ 4 points and/or AUR and/or BPH-related surgery, but does not reduce the primary occurrence of AUR. Alfuzosin significantly improves LUTS and quality of life over 2 years, and is well tolerated.

  • Alfuzosin 10 mg once daily in the management of acute urinary retention results of a double blind placebo controlled study
    Urology, 2006
    Co-Authors: S A Mcneill, T B Hargreave, Claus G Roehrborn
    Abstract:

    Abstract Objectives To study the impact of Alfuzosin 10 mg once daily (OD) on the outcome of a trial without catheter (TWOC) after a first episode of acute urinary retention (AUR) related to benign prostatic hyperplasia (BPH) and the subsequent management of BPH in these patients. Methods A total of 360 patients underwent emergency catheterization and were blindly randomized to Alfuzosin 10 mg OD or placebo for 3 days (first phase). All patients with successful TWOC, regardless of treatment, were then again blindly randomized to Alfuzosin 10 mg OD or placebo for 6 months (second phase). The need for BPH surgery (primary endpoint) was assessed after 1, 3, and 6 months of treatment. Results Alfuzosin significantly increased the successful TWOC rate (146 of 236, 61.9%) compared with placebo (58 of 121, 47.9%; P = 0.012). In the second phase, 14 (17.1%) of the 82 Alfuzosin-treated patients versus 20 (24.1%) of the 83 placebo-treated patients required BPH surgery, 5 (36%) of 14 versus 13 (65%) of 20 within 1 month, and 8 (57%) of 14 versus 17 (85%) of 20 within 3 months of treatment. Emergency surgery because of AUR relapse was the main cause of failure in both groups (11 [78.6%] of 14 in the Alfuzosin group and 16 [80.0%] of 20 in the placebo group). Compared with placebo, Alfuzosin improved the Kaplan-Meier survival rates by 9.6% ( P = 0.04), 11.4% ( P = 0.04), and 8.3% ( P = 0.20), with surgical risk reductions of 61%, 52%, and 29% at 1, 3, and 6 months of treatment, respectively. High prostate-specific antigen values and the post-TWOC residual urine volume significantly increased the risk of AUR relapse and BPH surgery. Alfuzosin 10 mg OD was well tolerated. Conclusions Alfuzosin 10 mg OD increased the likelihood of successful TWOC in men with a first episode of spontaneous AUR and should be continued beyond the acute phase, as it reduced the need for BPH surgery during a 6-month treatment period.

  • first dose efficacy of Alfuzosin once daily in men with symptomatic benign prostatic hyperplasia
    Urology, 2003
    Co-Authors: Leonard S Marks, Claus G Roehrborn, Marc Gittelman, John B Forrest, Sharon Jacobs
    Abstract:

    Objectives. To evaluate the onset of action of Alfuzosin once daily (OD) as determined by uroflowmetry early after initial dosing. Alfuzosin OD is an extended-release formulation of a uroselective, alpha1-adrenoreceptor-blocking agent (alpha-blocker) used in the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Methods. This was a randomized, placebo-controlled, two-way Latin square crossover study. Forty-nine patients were selected for this study on the basis of their symptomatic improvement during previous treatment with alpha-blockers and significant decreases in urinary flow rate when that treatment was withdrawn. Results. Our analysis showed that significant increases in the maximal urinary flow rate (Qmax) in 34 assessable patients occurred as soon as 8 hours after the initial dose of medication and persisted for at least 4 days. The Qmax for Alfuzosin 10 mg OD was 3.2 mL/s and for placebo it was 1.1 mL/s. The difference of means for the assessable population was 2.1 (95% confidence interval 0.8 to 3.4, P 0.002). The overall incidence of adverse events was low. Only dizziness, experienced by 3 patients treated with Alfuzosin compared with 1 patient treated with placebo, appeared to be related to the study drug. Conclusions. Together, our findings suggest that Alfuzosin OD exhibits a urodynamically measurable effect on bladder outlet obstruction due to benign prostatic hyperplasia in men with lower urinary tract symptoms within hours of the first administration. UROLOGY 62: 888‐893, 2003. © 2003 Elsevier Inc.

M C Delauchecavallier - One of the best experts on this subject based on the ideXlab platform.

  • clinical uroselectivity evidence from patients treated with slow release Alfuzosin for symptomatic benign prostatic obstruction
    BJUI, 1997
    Co-Authors: J M Buzelin, S Roth, C Geffriaudricouard, M C Delauchecavallier, J P Santoni
    Abstract:

    Objective  To assess the safety profile of slow-release (SR) Alfuzosin in the treatment of benign prostatic obstruction (BPO), with special attention to orthostatic blood pressure changes, postural symptoms and efficacy. Patients and methods Two placebo-controlled studies involving 588 patients (292 receiving SR Alfuzosin 5 mg twice daily and 296 a placebo) were pooled; 51% of the patients were ≥65 years of age and 43% had associated cardiovascular disease including hypertension and/or were receiving concomitant antihypertensive drugs. Results SR Alfuzosin was very well tolerated with an overall incidence of adverse events similar to that of placebo (18.5% and 15.8% of patients, respectively) and an overall incidence of withdrawal from therapy for adverse events lower than that of placebo (3.4% and 5.7%, respectively). Adverse events potentially related to vasodilatation were infrequent with SR Alfuzosin (the same incidence as with placebo, i.e. 2.7% of patients) and these adverse events occurred mainly during the first month of Alfuzosin treatment. The effect on supine blood pressure was minimal. In the subgroups of elderly and hypertensive patients treated with SR Alfuzosin, the cumulative incidence of asymptomatic orthostatic hypotension during the first month of treatment was slightly higher than with placebo with no objective consequences on the incidence of adverse events. The clinical efficacy of SR Alfuzosin was confirmed by a significant improvement in urinary symptoms and a significant increase in maximum flow rates. Conclusion SR Alfuzosin (10 mg/day) can be administered safely without titration in patients with BPO, even in elderly and hypertensive patients. Its favourable benefit/risk ratio allows Alfuzosin to be classified as a clinically uroselective α1-blocker. Specific analysis of orthostatic changes in blood pressure is important when assessing the safety profile of an α1-blocker in patients with BPO.

  • efficacy and safety of sustained release Alfuzosin 5 mg in patients with benign prostatic hyperplasia algebi study group
    European Urology, 1997
    Co-Authors: J M Buzelin, S Roth, C Geffriaudricouard, M C Delauchecavallier
    Abstract:

    OBJECTIVES: To assess the efficacy and safety of a sustained-release (SR) formulation of Alfuzosin, a selective alpha(1)-blocker, in patients with symptomatic benign prostatic hyperplasia (BPH). METHODS: A total of 390 men were randomly assigned to receive SR-Alfuzosin (n = 194), 5 mg twice daily without dose titration, or placebo (n = 196) for 12 weeks. Of the patients included, 47% had concomitant cardiovascular disease, mainly hypertension or coronary heart disease. RESULTS: SR-Alfuzosin significantly improved urinary symptoms versus placebo assessed using the I-PSS (-31 vs. -18%, p = 0.007) and Boyarsky (-30 vs. -16%, p < 0.001) scores, with a direct correlation between both scores. Maximum flow rate increased significantly with SR-Alfuzosin (+2.4 ml/s, i.e. +29%) compared with placebo (+1.1 ml/s, i.e. +14%, p = 0.006). Residual urine was also significantly reduced with SR-Alfuzosin. Overall, SR-Alfuzosin was as well tolerated as placebo. Nine patients dropped out for adverse events with SR-Alfuzosin (4.6%) and 14 (7.1%) with placebo. The incidence of vasodilation-related events (dizziness, postural symptoms, headache) with SR-Alfuzosin (3.1%) was similar to that of placebo (3.6%). No first-dose effect was observed compared with placebo. The reduction in supine blood pressure with SR-Alfuzosin was minor (< or = 5 mm Hg), both in normotensive and hypertensive patients. CONCLUSION: SR-Alfuzosin is an effective treatment of symptoms related to BPH that shows a good safety profile in normotensive and hypertensive patients, without the need of dose titration.

  • urinary flow rates in patients with benign prostatic hypertrophy following treatment with Alfuzosin
    BJUI, 1992
    Co-Authors: P Teillac, M C Delauchecavallier, P Attali
    Abstract:

    Summary— In order to document further the onset of action of Alfuzosin, a selective alpha-1 blocker, 93 symptomatic patients with benign prostatic hypertrophy were randomly allocated to a single oral dose of either Alfuzosin 1.25 mg or 2.5 mg, or placebo, after a 1-week placebo lead-in period. The effects on flow rates were assessed 1 h 30 min after administration. Peak and mean flow rates were significantly increased in the Alfuzosin groups, as compared with placebo, in a dose-dependent manner. After a single intake of placebo, the mean values of these 2 parameters showed little change. The effect on the cardiovascular system (heart rate and blood pressure) was mild. This study indicates that the action of Alfuzosin is already present 1 h 30 min after administration.

  • Alfuzosin for treatment of benign prostatic hypertrophy
    The Lancet, 1991
    Co-Authors: A Jardin, M C Delauchecavallier, H Bensadoun, P Attatli
    Abstract:

    Abstract To assess the long-term efficacy and safety of Alfuzosin, a selective α 1 -adrenergic antagonist, 518 symptomatic patients with benign prostatic hypertrophy (BPH) were randomised to received either Alfuzosin (daily dose 7·5-10 mg) or placebo for 6 months. Obstructive and irritative symptoms, assessed according to the Boyarsky scale, significantly improved in the Alfuzosin group compared with the placebo group (p=0·0004). Fewer patients in the Alfuzosin group than in the placebo group dropped out due to lack of efficacy (6·8% vs 14·6%, p=0·004) and the prevalence of spontaneous acute urine retention was lower in the Alfuzosin group (0·4% vs 2·6%, p=0·04). By 6 months, mean urinary flow rates had increased (p 1 adrenergic antagonist drugs provides long-lasting improvement in such patients.

Francois Giuliano - One of the best experts on this subject based on the ideXlab platform.

  • combination of Alfuzosin and tadalafil exerts an additive relaxant effect on human detrusor and prostatic tissues in vitro
    European Urology, 2010
    Co-Authors: Stephanie Oger, Laurent Alexandre, Delphine Behrroussel, Diane Gorny, Thierry Lebret, Yves Denoux, Francois Giuliano
    Abstract:

    Abstract Background Lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) are highly prevalent in aging men and are strongly linked. Alpha 1 -blockers such as Alfuzosin are effective monotherapies for LUTS. Phosphodiesterase type 5 (PDE5) inhibitors such as tadalafil are the first-line treatment for ED. Both drugs act by two different mechanisms of action on common urogenital target organs and, thus, may have additive effects. Objectives We evaluated in vitro the effects of Alfuzosin, tadalafil, and the combination of both on human detrusor and prostatic smooth muscle. Design, setting, and participants Prostatic and bladder tissue were obtained from patients ( n =20 and n =17, respectively) undergoing cystoprostatectomy for bladder cancer. Measurements In organ baths, isolated prostatic strips and isolated bladder strips were incubated with vehicle, tadalafil (10 −6 M and 10 −5 M), Alfuzosin (3×10 −8 M or 10 −6 M and 10 −5 M) or a combination. Concentration-response curves (CRCs) to norepinephrine were generated on prostatic strips and detrusor strips precontracted with carbachol. Strips were also submitted to electrical field stimulation (EFS). Results and limitations When Alfuzosin and tadalafil were combined, the maximal relaxation to norepinephrine on carbachol-precontracted detrusor strips was significantly increased compared with tadalafil alone, and EFS-induced detrusor contractions were better inhibited compared with each compound alone. Tadalafil significantly inhibited norepinephrine-induced prostatic strip contractions by reducing the maximal effect, whereas Alfuzosin shifted the CRC of norepinephrine to the right. Combining both tadalafil and Alfuzosin resulted in a greater relaxant effect. Likewise, the combination was more effective at reducing EFS-induced contractions compared with each compound alone. Conclusions The combination of Alfuzosin and tadalafil exerts an additive effect of inhibiting adrenergic smooth muscle tone of prostatic tissue and EFS-induced detrusor contractions and conversely, of enhancing adrenergic relaxation of detrusor precontracted with carbachol. These experiments provide experimental support for the clinical investigation of the combination of α1-blockers and PDE5 inhibitors in the treatment of LUTS.

  • combination of Alfuzosin and tadalafil exerts in vitro an additive relaxant effect on human corpus cavernosum
    The Journal of Sexual Medicine, 2008
    Co-Authors: Stephanie Oger, Laurent Alexandre, Delphine Behrroussel, Diane Gorny, Jack Charles Tremeaux, Michel Combes, Francois Giuliano
    Abstract:

    ABSTRACT Introduction Phosphodiesterase type 5 (PDE5) inhibitors, such as tadalafil, are a first-line treatment for erectile dysfunction (ED). Nevertheless, some patients do not respond to this treatment. Clinical data suggest that the addition of α1-adrenoceptor blocker, such as Alfuzosin, commonly prescribed for lower urinary tract symptoms suggestive of benign prostatic hyperplasia, may be of benefit. Aim Evaluation of the effect of Alfuzosin, tadalafil or the combination of both on human corpus cavernosum. Methods Human cavernosal tissues were obtained from 10 patients undergoing penile surgery. Strips contractility was studied in organ baths. Concentration–response curves to tadalafil were generated on norepinephrine (NE, 1–10 µM)-precontracted strips in the presence of Alfuzosin or vehicle. Frequency–response curves (FRC) to electrical field stimulation (EFS, 0–64 Hz, 3 ms, 10 seconds, 300 mA) were generated in the presence of vehicle, Alfuzosin, tadalafil, or both drugs combined. EFS (20 Hz, 1 ms, 10 seconds, 300 mM)-induced nitrergic relaxation on NE-precontracted strips was studied in the presence of vehicle, Alfuzosin, tadalafil, or both drugs combined. Main Outcome Measures Functional measurement of cavernosal smooth muscle relaxation in the presence of tadalafil and Alfuzosin. Results The relaxation induced by tadalafil (10 −10 to 10 −5  M) on precontracted strips was enhanced by Alfuzosin at both 10 −8 and 10 −7  M. The combination of Alfuzosin (3.10 −8  M) and tadalafil (10 −7  M) was more efficient to inhibit FRC-induced contractions than each compound alone. The combination of tadalafil (10 −6  M) and Alfuzosin (10 −8  M) increased the relaxation induced by EFS and its effect was greater than tadalafil alone. In addition, the combination of tadalafil (10 −6  M) and Alfuzosin (10 −7  M) prolonged EFS-induced relaxation to a greater extent than each compound alone. Conclusions In vitro, the combination of Alfuzosin and tadalafil is more efficient than each compound alone to relax adrenergic tone or to enhance nitrergic relaxation of the human corpus cavernosum. Such a combination deserves further investigation in placebo-controlled studies to evaluate its benefit in ED patients who are not sufficiently improved by PDE5 inhibitors. Oger S, Behr-Roussel D, Gorny D, Tremeaux JC, Combes M, Alexandre L, and Giuliano F. Combination of Alfuzosin and tadalafil exerts in vitro an additive relaxant effect on human corpus cavernosum.

Kang Chen - One of the best experts on this subject based on the ideXlab platform.

J M Buzelin - One of the best experts on this subject based on the ideXlab platform.

  • comparison of tamsulosin with Alfuzosin in the treatment of patients with lower urinary tract symptoms suggestive of bladder outlet obstruction symptomatic benign prostatic hyperplasia
    BJUI, 1997
    Co-Authors: J M Buzelin, E Fonteyne, M Kontturi, W P J Witjes
    Abstract:

    Objective  To compare the efficacy and tolerability of the a1A-subtype selective drug tamsulosin with the non-subtype-selective agent Alfuzosin in the treatment of patients with lower urinary tract symptoms (LUTS) suggestive of bladder outlet obstruction (BOO), often termed symptomatic benign prostatic hyperplasia (BPH). Patients and methods  The study comprised 256 patients with benign prostatic enlargement and LUTS suggestive of BOO (symptomatic BPH) who received tamsulosin 0.4 mg once daily or Alfuzosin 2.5 mg three times daily during 12 weeks of treatment. The response was assessed by measurements of maximum urinary flow rate (Qmax ), a symptom score (Boyarsky) and blood pressure at regular intervals. Results  Tamsulosin and Alfuzosin produced comparable improvements in Qmax and total Boyarsky symptom score. Both treatments were well tolerated with respect to adverse events. Tamsulosin had no statistically significant effect on blood pressure compared with baseline but Alfuzosin induced a significant reduction in both standing and supine blood pressure, compared with baseline (P<0.05). Conclusion  Tamsulosin is the first adrenoceptor antagonist that is selective for the a1A-subtype; this specificity may explain its lack of effect on blood pressure compared with Alfuzosin, an agent that is not receptor subtype specific. Moreover, this finding may partly explain why tamsulosin, in contrast to other currently available a1-adrenoceptor antagonists, can be administered without dose titration. Another advantage compared with Alfuzosin (and prazosin) is the once-daily dosing regimen of tamsulosin.

  • clinical uroselectivity evidence from patients treated with slow release Alfuzosin for symptomatic benign prostatic obstruction
    BJUI, 1997
    Co-Authors: J M Buzelin, S Roth, C Geffriaudricouard, M C Delauchecavallier, J P Santoni
    Abstract:

    Objective  To assess the safety profile of slow-release (SR) Alfuzosin in the treatment of benign prostatic obstruction (BPO), with special attention to orthostatic blood pressure changes, postural symptoms and efficacy. Patients and methods Two placebo-controlled studies involving 588 patients (292 receiving SR Alfuzosin 5 mg twice daily and 296 a placebo) were pooled; 51% of the patients were ≥65 years of age and 43% had associated cardiovascular disease including hypertension and/or were receiving concomitant antihypertensive drugs. Results SR Alfuzosin was very well tolerated with an overall incidence of adverse events similar to that of placebo (18.5% and 15.8% of patients, respectively) and an overall incidence of withdrawal from therapy for adverse events lower than that of placebo (3.4% and 5.7%, respectively). Adverse events potentially related to vasodilatation were infrequent with SR Alfuzosin (the same incidence as with placebo, i.e. 2.7% of patients) and these adverse events occurred mainly during the first month of Alfuzosin treatment. The effect on supine blood pressure was minimal. In the subgroups of elderly and hypertensive patients treated with SR Alfuzosin, the cumulative incidence of asymptomatic orthostatic hypotension during the first month of treatment was slightly higher than with placebo with no objective consequences on the incidence of adverse events. The clinical efficacy of SR Alfuzosin was confirmed by a significant improvement in urinary symptoms and a significant increase in maximum flow rates. Conclusion SR Alfuzosin (10 mg/day) can be administered safely without titration in patients with BPO, even in elderly and hypertensive patients. Its favourable benefit/risk ratio allows Alfuzosin to be classified as a clinically uroselective α1-blocker. Specific analysis of orthostatic changes in blood pressure is important when assessing the safety profile of an α1-blocker in patients with BPO.

  • Clinical uroselectivity: evidence from patients treated with slow‐release Alfuzosin for symptomatic benign prostatic obstruction
    BJUI, 1997
    Co-Authors: J M Buzelin, S Roth, M.c. Delauche-cavallier, C. Geffriaud-ricouard, J P Santoni
    Abstract:

    Objective  To assess the safety profile of slow-release (SR) Alfuzosin in the treatment of benign prostatic obstruction (BPO), with special attention to orthostatic blood pressure changes, postural symptoms and efficacy. Patients and methods Two placebo-controlled studies involving 588 patients (292 receiving SR Alfuzosin 5 mg twice daily and 296 a placebo) were pooled; 51% of the patients were ≥65 years of age and 43% had associated cardiovascular disease including hypertension and/or were receiving concomitant antihypertensive drugs. Results SR Alfuzosin was very well tolerated with an overall incidence of adverse events similar to that of placebo (18.5% and 15.8% of patients, respectively) and an overall incidence of withdrawal from therapy for adverse events lower than that of placebo (3.4% and 5.7%, respectively). Adverse events potentially related to vasodilatation were infrequent with SR Alfuzosin (the same incidence as with placebo, i.e. 2.7% of patients) and these adverse events occurred mainly during the first month of Alfuzosin treatment. The effect on supine blood pressure was minimal. In the subgroups of elderly and hypertensive patients treated with SR Alfuzosin, the cumulative incidence of asymptomatic orthostatic hypotension during the first month of treatment was slightly higher than with placebo with no objective consequences on the incidence of adverse events. The clinical efficacy of SR Alfuzosin was confirmed by a significant improvement in urinary symptoms and a significant increase in maximum flow rates. Conclusion SR Alfuzosin (10 mg/day) can be administered safely without titration in patients with BPO, even in elderly and hypertensive patients. Its favourable benefit/risk ratio allows Alfuzosin to be classified as a clinically uroselective α1-blocker. Specific analysis of orthostatic changes in blood pressure is important when assessing the safety profile of an α1-blocker in patients with BPO.

  • efficacy and safety of sustained release Alfuzosin 5 mg in patients with benign prostatic hyperplasia algebi study group
    European Urology, 1997
    Co-Authors: J M Buzelin, S Roth, C Geffriaudricouard, M C Delauchecavallier
    Abstract:

    OBJECTIVES: To assess the efficacy and safety of a sustained-release (SR) formulation of Alfuzosin, a selective alpha(1)-blocker, in patients with symptomatic benign prostatic hyperplasia (BPH). METHODS: A total of 390 men were randomly assigned to receive SR-Alfuzosin (n = 194), 5 mg twice daily without dose titration, or placebo (n = 196) for 12 weeks. Of the patients included, 47% had concomitant cardiovascular disease, mainly hypertension or coronary heart disease. RESULTS: SR-Alfuzosin significantly improved urinary symptoms versus placebo assessed using the I-PSS (-31 vs. -18%, p = 0.007) and Boyarsky (-30 vs. -16%, p < 0.001) scores, with a direct correlation between both scores. Maximum flow rate increased significantly with SR-Alfuzosin (+2.4 ml/s, i.e. +29%) compared with placebo (+1.1 ml/s, i.e. +14%, p = 0.006). Residual urine was also significantly reduced with SR-Alfuzosin. Overall, SR-Alfuzosin was as well tolerated as placebo. Nine patients dropped out for adverse events with SR-Alfuzosin (4.6%) and 14 (7.1%) with placebo. The incidence of vasodilation-related events (dizziness, postural symptoms, headache) with SR-Alfuzosin (3.1%) was similar to that of placebo (3.6%). No first-dose effect was observed compared with placebo. The reduction in supine blood pressure with SR-Alfuzosin was minor (< or = 5 mm Hg), both in normotensive and hypertensive patients. CONCLUSION: SR-Alfuzosin is an effective treatment of symptoms related to BPH that shows a good safety profile in normotensive and hypertensive patients, without the need of dose titration.

  • alpha blocking treatment with Alfuzosin in symptomatic benign prostatic hyperplasia comparative study with prazosin
    BJUI, 1993
    Co-Authors: J M Buzelin, M Hebert, P Blondin
    Abstract:

    : Alfuzosin, a selective alpha 1-adrenoceptor antagonist which is effective in the symptomatic treatment of benign prostatic hyperplasia (BPH), was compared with prazosin, another drug commonly used for the same purpose. After a 1-week placebo run-in period, 103 patients with day-time frequency > or = 7 or nocturia > or = 2 and peak flow rate < 15 ml/s were randomised to receive either Alfuzosin (2.5 mg tid) or prazosin (2 mg bid) for 3 weeks, with a gradual dose increase during the first week, in a double-blind, parallel group, multicentre study. Voiding symptoms, assessed on the basis of the Boyarsky scale and a micturition diary, were significantly improved in both groups, as were urinary flow rates. However, neither the clinical improvement nor the increase in flow rates differed significantly between the 2 groups. The peak flow rate increased similarly with Alfuzosin (2.6 +/- 0.6 ml/s) and prazosin (2.9 +/- 0.7 ml/s); the mean flow rate and voided volume increase tended to be more marked with Alfuzosin (30 and 22.2% respectively) than with prazosin (20.6 and 6.5%). Clinical safety was good in both groups. All 4 adverse events in the prazosin group but only 1 of the 4 adverse events in the Alfuzosin group were related to a decrease in blood pressure. It was concluded that Alfuzosin was at least as effective as prazosin in the treatment of symptomatic patients with BPH and the incidence of adverse events related to their vasodilatory properties was lower with Alfuzosin.