Efficacy and safety of a new prolonged release formulation of alfuzosin 10 mg once daily versus alfuzosin 2.5 mg thrice daily and placebo in patients with symptomatic benign prostatic hyperplasia.
About: This article is published in Current Opinion in Urology.The article was published on 2000-11-01. It has received 43 citations till now. The article focuses on the topics: Alfuzosin & Placebo.
Citations
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TL;DR: To examine the efficacy and safety of a once‐daily formulation of alfuzosin in a pooled analysis of three parallel, randomized, double‐blind, placebo‐controlled 3‐month studies of patients with lower urinary tract symptoms consistent with clinical benign prostatic hyperplasia.
Abstract: OBJECTIVES
To examine the efficacy and safety of a once-daily formulation of alfuzosin in a pooled analysis of three parallel, randomized, double-blind, placebo-controlled 3-month studies of patients with lower urinary tract symptoms (LUTS) consistent with clinical benign prostatic hyperplasia.
PATIENTS AND METHODS
Patients were randomized to receive alfuzosin, 10 mg once-daily (473) or placebo (482) for 12 weeks. Primary efficacy criteria were improvements in the International Prostate Symptom Score (IPSS) and peak urinary flow rate (PFR).
RESULTS
Alfuzosin significantly improved the mean (sd) IPSS, by − 6.0 (5.1) vs − 4.2 (5.7) with placebo (P < 0.005) and the PFR, by + 2.3 (3.8) vs + 1.1 (3.1) ml/s with placebo (P < 0.001), irrespective of prostate size. The significant improvement in LUTS included the irritative and the obstructive subscore of the IPSS and the nocturia criterion; the PFR increased rapidly and significantly, from the first visit (14 days). The quality-of-life score also improved significantly in alfuzosin-treated patients. Alfuzosin was well tolerated; the number of withdrawals for adverse events was comparable in both treatment groups. The most frequently reported adverse event was dizziness (placebo 2.9%, alfuzosin 6.1%). There were no significant changes in blood pressure with alfuzosin compared with placebo, including in elderly and hypertensive patients. Sexual adverse events were rare (abnormal ejaculation, 0.6%).
CONCLUSIONS
The once-daily formulation of alfuzosin, administered at 10 mg with no dose titration is effective, with a good safety profile, especially in elderly and hypertensive patients.
167 citations
TL;DR: Significant improvements from baseline in IPSS, Q(max), TPV, and TZV were observed for all groups, including placebo, at week 12, with no significant differences between onabotulinumtoxinA and placebo.
95 citations
TL;DR: Tamsulosin, alfuzosin slow release and silodosin do not require dose titration, and have all been shown to be effective in relieving LUTS/BPH independent of prostate size.
Abstract: Purpose of review α1-Adrenoceptor blockers are the most frequently prescribed medical therapy in the treatment of lower urinary tract symptom suggestive of benign prostatic hyperplasia (LUTS/BPH). The purpose of this review is to highlight the evolution of adrenoceptor blockers with emphasis on newly approved drugs. Recent findings Over the past years new formulations of several α1-adrenoceptor blockers were introduced to the market. Five long-acting α1-blockers are currently approved by the Food and Drug Administration for treatment of symptomatic LUTS/BPH: terazosin, doxazosin, tamsulosin, alfuzosin and silodosin. Silodosin is the only adrenoceptor blocker that exhibits true selectivity for the α1-adrenoceptor subtypes. This unique adrenoceptor selectivity profile likely accounts for the very favorable cardiovascular safety profile. Summary Tamsulosin, alfuzosin slow release and silodosin do not require dose titration. Alfuzosin, terazosin, doxazosin and silodosin have all been shown to be effective in relieving LUTS/BPH independent of prostate size. Low incidence of orthostatic hypotension has been reported for silodosin, but abnormal ejaculation is the most commonly reported adverse effect.
85 citations
TL;DR: There seems to be a consensus that clinically available α1-AR antagonists provide a safe, effective and generally well-tolerated therapy for patients with LUTS.
Abstract: The selective blockade of α1-adrenoceptors (ARs) is now a well-accepted and widely used treatment for patients presenting with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and bladder outlet obstruction. The sites of action of the currently used α1-AR antagonists when relieving LUTS have not yet been established, but it seems clear that effects on prostatic as well as non-prostatic tissues are important. α1-ARs in the bladder, urethra, and vas deferens, on ganglia and nerve terminals, and in the central nervous system (CNS) may all influence LUTS and the clinical effects of α1-AR antagonists. The relevance of α1-AR subtype selectivity for the clinical usefulness of existing drug therapy has still not been clarified, but it cannot be dismissed that blockading both α1A- and α1D-ARs is necessary for optimal clinical effect. Despite the above uncertainties, there seems to be a consensus that clinically available α1-AR antagonists provide a safe, effective and generally well-tolerated therapy for patients with LUTS.
72 citations
Cites background from "Efficacy and safety of a new prolon..."
...For example, the alfuzosin XL formulation can be given once daily without a loss of efficacy and with a promise of improved safety [69, 80]....
[...]
TL;DR: The aim of this review is to examine current pharmacotherapies as well as to highlight emerging drugs that may improve the treatment of patients with LUTS secondary to BPH.
Abstract: Benign prostatic hyperplasia (BPH) is the nonmalignant enlargement of the prostate gland caused by increases in number of both epithelial and stromal cells. Clinically, BPH leads to voiding dysfunction, which is most often referred to as lower urinary tract symptoms (LUTS). Historically, the only treatments for LUTS due to BPH were watchful waiting or surgery (transurethral or open prostatectomy). However, over the last 20 years medical therapy has taken a prominent role in the management of BPH. Current medical treatments for BPH include alpha-adrenergic receptor antagonists, inhibitors of the 5-alpha reductase enzyme and various phytotherapies. These agents are generally effective and safe; however, many patients are unable to tolerate the side effects or are refractory to medical management and require surgery. In light of this, many potential new therapies for the treatment of BPH are under development. Some represent a variation of current treatments, whereas others target novel molecular pathways within the prostate. The aim of this review is to examine current pharmacotherapies as well as to highlight emerging drugs that may improve our treatment of patients with LUTS secondary to BPH.
62 citations
Cites background from "Efficacy and safety of a new prolon..."
...There was no change in blood pressure in hypertensive or normotensive subjects and no patients reported ejaculatory disturbances [22]....
[...]
References
More filters
TL;DR: To examine the efficacy and safety of a once‐daily formulation of alfuzosin in a pooled analysis of three parallel, randomized, double‐blind, placebo‐controlled 3‐month studies of patients with lower urinary tract symptoms consistent with clinical benign prostatic hyperplasia.
Abstract: OBJECTIVES
To examine the efficacy and safety of a once-daily formulation of alfuzosin in a pooled analysis of three parallel, randomized, double-blind, placebo-controlled 3-month studies of patients with lower urinary tract symptoms (LUTS) consistent with clinical benign prostatic hyperplasia.
PATIENTS AND METHODS
Patients were randomized to receive alfuzosin, 10 mg once-daily (473) or placebo (482) for 12 weeks. Primary efficacy criteria were improvements in the International Prostate Symptom Score (IPSS) and peak urinary flow rate (PFR).
RESULTS
Alfuzosin significantly improved the mean (sd) IPSS, by − 6.0 (5.1) vs − 4.2 (5.7) with placebo (P < 0.005) and the PFR, by + 2.3 (3.8) vs + 1.1 (3.1) ml/s with placebo (P < 0.001), irrespective of prostate size. The significant improvement in LUTS included the irritative and the obstructive subscore of the IPSS and the nocturia criterion; the PFR increased rapidly and significantly, from the first visit (14 days). The quality-of-life score also improved significantly in alfuzosin-treated patients. Alfuzosin was well tolerated; the number of withdrawals for adverse events was comparable in both treatment groups. The most frequently reported adverse event was dizziness (placebo 2.9%, alfuzosin 6.1%). There were no significant changes in blood pressure with alfuzosin compared with placebo, including in elderly and hypertensive patients. Sexual adverse events were rare (abnormal ejaculation, 0.6%).
CONCLUSIONS
The once-daily formulation of alfuzosin, administered at 10 mg with no dose titration is effective, with a good safety profile, especially in elderly and hypertensive patients.
167 citations
TL;DR: Significant improvements from baseline in IPSS, Q(max), TPV, and TZV were observed for all groups, including placebo, at week 12, with no significant differences between onabotulinumtoxinA and placebo.
95 citations
TL;DR: Tamsulosin, alfuzosin slow release and silodosin do not require dose titration, and have all been shown to be effective in relieving LUTS/BPH independent of prostate size.
Abstract: Purpose of review α1-Adrenoceptor blockers are the most frequently prescribed medical therapy in the treatment of lower urinary tract symptom suggestive of benign prostatic hyperplasia (LUTS/BPH). The purpose of this review is to highlight the evolution of adrenoceptor blockers with emphasis on newly approved drugs. Recent findings Over the past years new formulations of several α1-adrenoceptor blockers were introduced to the market. Five long-acting α1-blockers are currently approved by the Food and Drug Administration for treatment of symptomatic LUTS/BPH: terazosin, doxazosin, tamsulosin, alfuzosin and silodosin. Silodosin is the only adrenoceptor blocker that exhibits true selectivity for the α1-adrenoceptor subtypes. This unique adrenoceptor selectivity profile likely accounts for the very favorable cardiovascular safety profile. Summary Tamsulosin, alfuzosin slow release and silodosin do not require dose titration. Alfuzosin, terazosin, doxazosin and silodosin have all been shown to be effective in relieving LUTS/BPH independent of prostate size. Low incidence of orthostatic hypotension has been reported for silodosin, but abnormal ejaculation is the most commonly reported adverse effect.
85 citations
TL;DR: There seems to be a consensus that clinically available α1-AR antagonists provide a safe, effective and generally well-tolerated therapy for patients with LUTS.
Abstract: The selective blockade of α1-adrenoceptors (ARs) is now a well-accepted and widely used treatment for patients presenting with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and bladder outlet obstruction. The sites of action of the currently used α1-AR antagonists when relieving LUTS have not yet been established, but it seems clear that effects on prostatic as well as non-prostatic tissues are important. α1-ARs in the bladder, urethra, and vas deferens, on ganglia and nerve terminals, and in the central nervous system (CNS) may all influence LUTS and the clinical effects of α1-AR antagonists. The relevance of α1-AR subtype selectivity for the clinical usefulness of existing drug therapy has still not been clarified, but it cannot be dismissed that blockading both α1A- and α1D-ARs is necessary for optimal clinical effect. Despite the above uncertainties, there seems to be a consensus that clinically available α1-AR antagonists provide a safe, effective and generally well-tolerated therapy for patients with LUTS.
72 citations
TL;DR: The aim of this review is to examine current pharmacotherapies as well as to highlight emerging drugs that may improve the treatment of patients with LUTS secondary to BPH.
Abstract: Benign prostatic hyperplasia (BPH) is the nonmalignant enlargement of the prostate gland caused by increases in number of both epithelial and stromal cells. Clinically, BPH leads to voiding dysfunction, which is most often referred to as lower urinary tract symptoms (LUTS). Historically, the only treatments for LUTS due to BPH were watchful waiting or surgery (transurethral or open prostatectomy). However, over the last 20 years medical therapy has taken a prominent role in the management of BPH. Current medical treatments for BPH include alpha-adrenergic receptor antagonists, inhibitors of the 5-alpha reductase enzyme and various phytotherapies. These agents are generally effective and safe; however, many patients are unable to tolerate the side effects or are refractory to medical management and require surgery. In light of this, many potential new therapies for the treatment of BPH are under development. Some represent a variation of current treatments, whereas others target novel molecular pathways within the prostate. The aim of this review is to examine current pharmacotherapies as well as to highlight emerging drugs that may improve our treatment of patients with LUTS secondary to BPH.
62 citations