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

Kerrebroeck, Philip Van; Jardin, A; Laval, K. U.; Cangh, Paul Van

doi:10.1159/000052361

Cited by 136 publications

(91 citation statements)

References 26 publications

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“…The severity of LUTS was categorized as mild (score < 8), moderate (8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19) and severe (20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35). The bother score was categorized as ≤ 3 and > 3 (i.e.…”

Section: Alfmentioning

confidence: 99%

Long‐term efficacy and safety of alfuzosin 10 mg once daily: a 2‐year experience in ‘real‐life’ practice

Elhilali

Emberton

Matzkin³

et al. 2006

BJU International

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OBJECTIVETo assess the 2-year efficacy and safety of alfuzosin 10 mg once daily, a selective α 1 -adrenoceptor antagonist, in men complaining of lower urinary tract symptoms (LUTS) suggestive of benign prostate hyperplasia (BPH), in 'real life' practice. PATIENTS AND METHODSIn all, 839 European men with LUTS (mean age 67.3 years) were enrolled by general practitioners in a 2-year open-label study with alfuzosin 10 mg once daily. They were asked to complete the International Prostate Symptom Score (IPSS), its appended eighth question (bother score), and the five domains (sexual drive, erection, ejaculation, problem assessment, and overall satisfaction) of the Brief Male Sexual Function Inventory (BSFI). The results were analysed at the endpoint in the intent-to-treat population. RESULTSAt the endpoint the total IPSS improved by 7 points ( − 38.5%) from baseline ( P < 0.001) with 76.9% and 49.7% of men having an improvement of ≥ 3 points and > 6 points, respectively. There were also significant improvements in nocturia ( − 0.9, − 30%; P < 0.001) and bother score ( − 1.8, − 43%; P < 0.001) from baseline. Most patients (56%) perceived symptom relief within the first 2 weeks of treatment. All BSFI domains significantly improved from baseline ( P < 0.05; < 0.001 for overall satisfaction) and these improvements were more marked in men with severe LUTS at baseline. Alfuzosin 10 mg was well tolerated; the most common adverse event related to vasodilatation was dizziness/postural dizziness (3.1%). Ejaculatory disorders were uncommon (0.3%). Changes in blood pressure remained marginal, including in elderly men and those receiving antihypertensive agents. CONCLUSIONSAlfuzosin 10 mg administered for 2 years in real practice is effective in improving LUTS and quality of life, and is well tolerated from a cardiovascular perspective, including in elderly men and those receiving antihypertensive co-medication. Ejaculatory disorders are uncommon. Alfuzosin may even slightly improve various domains of sexual function, such as sexual drive, erection, ejaculation and satisfaction with sexual life. A joint study was conducted by authors from Argentina and Brazil into the use of an adjustable male sling in the treatment of incontinence after prostatectomy. They were encouraged by the early results, feeling that the product they were evaluating might potentially present an alternative to the use of the artificial urinary sphincter in this condition.

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Section: Alfmentioning

confidence: 99%

Long‐term efficacy and safety of alfuzosin 10 mg once daily: a 2‐year experience in ‘real‐life’ practice

Elhilali

Emberton

Matzkin³

et al. 2006

BJU International

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“…The OD regimen was approximately equal in overall efficacy to the TID regimen. Extended-release alfuzosin 10 mg OD showed almost the same efficacy as 2.5 mg TID, although the dosage regimen was different [12]. In a comparative study of naftopidil 50 mg/day dosage regimens with OD administration in the morning and twicedaily (BID) administration in the morning and evening, the efficacy for subjective symptoms was approximately equal, but MFR showed that the effectiveness of the OD regimen started earlier than that of the BID regimen [13].…”

Section: Discussionmentioning

confidence: 99%

A Randomized Study Comparing Once-Daily and Thrice-Daily Naftopidil 75 mg/Day for Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia

Okumura

2014

World J Nephrol Urol

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Background: The efficacy and tolerability of naftopidil 75 mg administered once daily (OD) in the evening (group O) were compared to those of naftopidil 25 mg thrice daily (TID), given in the morning, afternoon and evening (group T), for lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/ BPH). The factors predicting the efficacy of each dosage regimen were also examined.

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“…Firstly, for alfuzosin (43), doxazosin (44), and tamsulosin (45), multiple pharmaceutical formulations have been developed and those with a smoother pharmacokinetic profile tend to have fewer adverse effects, although such differences typically did not reach statistical significance in phase III studies. However, dedicated clinical pharmacology studies have shown that the novel OCAS formulation of tamsulosin has fewer cardiovascular effects than the previously used formulation (46,47).…”

Section: Tolerabilitymentioning

confidence: 99%

The Forefront for Novel Therapeutic Agents Based on the Pathophysiology of Lower Urinary Tract Dysfunction: α-Blockers in the Treatment of Male Voiding Dysfunction — How Do They Work and Why Do They Differ in Tolerability?

Michel

2010

J Pharmacol Sci

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Abstract. α 1 -Adrenoceptor antagonists are the mainstay of medical treatment of male voiding dysfunction which typically is attributed to benign prostatic hyperplasia. While original concepts have assumed that they relieve voiding dysfunction by relaxing prostatic smooth muscle, newer data indicate that their therapeutic effects at least partly occur independent of prostatic relaxation, perhaps involving direct effects on blood vessels, urothelium, afferent nerves, and/or smooth muscle of the urinary bladder. The adverse event profiles differ among α 1 -adrenoceptor antagonists, with tamsulosin having a particularly good cardiovascular tolerability. While this was originally attributed to its selectivity for α 1A -adrenoceptors, it appears that alfuzosin which lacks subtype-selectivity, has a very similar tolerability. In contrast, doxazosin and terazosin, which are chemically and pharmacologically more closely related to alfuzosin than to tamsulosin, appear to have more side effects attributable to the cardiovascular system. More recent data indicate that tolerability differences between α 1 -adrenoceptor antagonists may at least partly relate to pharmacokinetic rather than to pharmacodynamic differences. Taken together, these data emphasize the idea that concepts about drug efficacy and tolerability despite being highly plausible may not necessarily be true and always require thorough experimental testing.

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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

Cited by 136 publications

References 26 publications

Long‐term efficacy and safety of alfuzosin 10 mg once daily: a 2‐year experience in ‘real‐life’ practice

Long‐term efficacy and safety of alfuzosin 10 mg once daily: a 2‐year experience in ‘real‐life’ practice

A Randomized Study Comparing Once-Daily and Thrice-Daily Naftopidil 75 mg/Day for Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia

The Forefront for Novel Therapeutic Agents Based on the Pathophysiology of Lower Urinary Tract Dysfunction: α-Blockers in the Treatment of Male Voiding Dysfunction — How Do They Work and Why Do They Differ in Tolerability?

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