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Alfuzosin

A Review of the Therapeutic Use of the Prolonged-Release Formulation Given Once Daily in the Management of Benign Prostatic Hyperplasia

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Summary

Abstract

Alfuzosin, a quinazoline derivative, is a selective and competitive α1-adrenoceptor antagonist. It distributes preferentially in the prostate, compared with plasma, and decreases the sympathetically controlled tone of prostatic smooth muscle. As a result lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH) are improved.

The once-daily formulation of alfuzosin contains inactive barrier layers which have been added to the planar surfaces of compressed tablets. Drug release is sustained over 20 hours with a near constant dissolution rate between 2 and 12 hours. Mean values for area under the plasma concentration-time curve over 24 hours (AUC24) were similar after administration of prolonged-release alfuzosin 10mg once daily and immediate-release alfuzosin 2.5mg three times daily. Likewise, similar AUC24 values were reported when prolonged-release alfuzosin 10mg once daily and sustained-release alfuzosin 5mg twice daily were compared. These data suggest that these alfuzosin regimens provide similar average systemic exposure.

Data from short- (3 months) and long-term (up to 12 months) clinical trials show that the prolonged-release formulation of alfuzosin controls the symptoms associated with BPH as effectively as immediate-release alfuzosin 2.5mg three times daily and clinical improvement is maintained for up to 1 year. Improvements in International Prostate Symptom Score, maximum urinary flow rate and quality-of-life index were improved to a similar extent in patients treated with immediate- or prolonged-release alfuzosin and improvements were statistically significant compared with placebo.

Prolonged-release alfuzosin 10mg is well tolerated and the overall incidence of adverse events is similar to that seen with placebo. The once-daily formulation of alfuzosin 10mg caused fewer vasodilatory adverse events than immediate-release alfuzosin 2.5mg three times daily and caused only slight decreases in systolic and diastolic blood pressure which were not clinically significant and did not differ significantly from those with placebo. No dosage titration is required. The incidence of ejaculatory disorders was <1%.

Conclusion: Prolonged-release alfuzosin 10mg once daily controls symptoms associated with BPH throughout a 24-hour dosage interval as effectively as immediate-release alfuzosin 2.5mg three times daily but with fewer vasodilatory adverse events. A nonblind extension study showed that clinical benefits were maintained for up to 1 year and the once-daily 10mg formulation continued to be well tolerated, particularly in terms of cardiovascular effects and sexual function. Thus, for the medical management of men with BPH, prolonged-release alfuzosin 10mg is an effective, well tolerated and convenient treatment option.

Pharmacodynamic Properties

Alfuzosin, a quinazoline derivative, is a selective and competitive α1-adrenoceptor antagonist which decreases the sympathetically controlled tone of prostatic smooth muscle, thereby improving lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). Alfuzosin has high affinity for postjunctional α1-adrenoceptors in human prostatic adenoma and demonstrates competitive antagonism at the α1-adrenoceptor site in vitro. In in vivo animal models, alfuzosin is more selective for ai-adrenoceptors in the genitourinary tract than prazosin and terazosin and distributes preferentially in the prostate compared with plasma. In a binding study using enzymatically isolated myocytes of human prostate and renal artery, alfuzosin appeared to be more selective for the prostate than tamsulosin, doxazosin and terazosin. In patients with BPH, alfuzosin concentrations in the prostate were higher than those found in plasma 12 hours after the final oral dose (prostate/plasma ratio 2.39).

Urinary flow rate increased significantly and dose dependently 90 minutes after a single oral dose (2.5mg) and after multiple doses of alfuzosin in patients with BPH. Alfuzosin 2.5mg three times daily significantly lowered detrusor pressure at maximum flow, detrusor opening pressure and maximum detrusor pressure compared with placebo. Postvoid residual urine volume was lower, and acute urinary retention less frequent in patients receiving alfuzosin compared with placebo.

Pharmacokinetic Properties

The prolonged-release formulation of alfuzosin 10mg contains inactive barrier layers which have been added to the planar surfaces of compressed tablets. The resulting three-layered matrix contains the active substance between two inactive layers, one swellable and one erodible, which facilitate a controlled release over the dosage interval. Drug release is sustained over 20 hours with a near constant dissolution rate between 2 and 12 hours. In fasting conditions, the plasma levels of alfuzosin are decreased. Although there are no safety concerns in fasting conditions, alfuzosin should be taken after a meal.

In multiple-dose studies in healthy volunteers, maximum plasma concentration (16.6 μg/L) was achieved at 9 hours after post prandial administration of prolonged-release alfuzosin 10mg compared with 20.2 to 21.6 μg/L achieved 1 hour after administration of the immediate-release 2.5mg formulation administered three times daily. The mean area under the plasma concentration-time curve over 24 hours after administration of prolonged-release alfuzosin 10mg once daily and immediate-release alfuzosin 2.5mg three times daily was similar (238 vs 233 μg ⋅ h/L). Interindividual variability was also similar for both regimens (31.2 and 27%, respectively). Mean AUC24 values were also similar after administration of prolonged-release alfuzosin 10mg once daily and sustained-release alfuzosin 5mg twice daily (161 vs 151 μg ⋅ h/L). These data suggest that these alfuzosin regimens provide similar average systemic exposure.

Alfuzosin is approximately 90% protein bound in plasma, and in healthy volunteers the volume of distribution is 2.5 L/kg.

Plasma elimination half-life after multiple doses of prolonged-release alfuzosin 10mg orally once daily was 9.1 hours compared with 7 hours for immediate-release alfuzosin 2.5mg three times daily. In young healthy volunteers the total plasma clearance of alfuzosin is 0.36 L/h/kg. Alfuzosin is extensively metabolised by the liver and the majority of the metabolites (which are inactive) are excreted in the faeces (75 to 91%).

In elderly healthy volunteers there are no clinically relevant differences in haemodynamic parameters between prolonged-release alfuzosin 10mg once daily and immediate-release alfuzosin 2.5mg three times daily. No dosage reduction of prolonged release alfuzosin is required in elderly patients.

Dosage modification is not required in patients with renal insufficiency, even when severe. In contrast, alfuzosin is contraindicated in patients with hepatic impairment.

Clinical Efficacy

Once-daily administration of the prolonged-release formulation of alfuzosin 10mg effectively controlled LUTS suggestive of BPH throughout a 24-hour dosage interval, and clinical improvement was maintained for up to 1 year.

Data from two well designed 3-month clinical trials show that prolonged-release alfuzosin 10mg once daily is as effective as immediate-release alfuzosin 2.5mg three times daily. A higher dosage of prolonged-release alfuzosin 15mg did not provide additional benefit in terms of efficacy compared with 10mg once daily.

Prolonged-release alfuzosin 10mg once daily and immediate-release alfuzosin 2.5mg three times daily showed similar improvements in International Prostate Symptom Score (IPSS) in 436 patients with BPH in a randomised double-blind trial. Improvements obtained in IPSS with both alfuzosin regimens were significantly better than with placebo. In the intent-to-treat analysis, mean change from baseline at endpoint was 40% for patients receiving alfuzosin 10mg once daily, 38% for patients receiving alfuzosin 2.5mg three times daily, and 28% for patients receiving placebo.

The mean change in the maximum urinary flow rate from baseline was significantly greater in patients receiving prolonged-release alfuzosin 10mg than those receiving placebo in both 3-month studies. In the ALFORTI study, this significant difference was achieved despite uroflowmetry being performed at trough plasma levels (approximately 20 hours after the last dose). Near maximum improvements were evident at the first follow-up visit (day 14) with both alfuzosin 10mg once daily and 2.5mg three times daily.

Quality of life (QOL) also improved significantly in patients treated with alfuzosin compared with placebo. At endpoint the QOL index reduced by 33, 30 and 18% with alfuzosin 10mg once daily (prolonged-release) and 2.5mg three times daily (immediate-release) and placebo, respectively.

Clinical benefits are maintained for up to 12 months as demonstrated in a 9-month nonblind extension phase of a 3-month double-blind study comparing prolonged-release alfuzosin 10mg once daily with immediate-release alfuzosin 2.5mg three times daily and placebo. All patients (n = 311) received prolonged-release alfuzosin 10mg once daily throughout the extension phase. The mean improvement in IPSS, evident at month 3 (start of extension phase), was maintained throughout the 9-month study. IPSS improved from 17.1 for all treatment groups at baseline to 10.9 at the start of the extension phase, to 9.3 at endpoint. Patients randomised to placebo in the initial 3-month study showed a significant improvement between months 3 and 12.

Tolerability

Prolonged-release alfuzosin 10mg once daily is well tolerated in the short and long term (up to 12 months) in patients with BPH. The overall incidence of adverse events is similar to that seen with placebo.

As with all α1-adrenoceptor antagonists, vasodilatory adverse events are the most common. However, prolonged-release alfuzosin 10mg once daily caused fewer vasodilatory-related events (dizziness, headache, hypotension, postural hypotension, malaise) than immediate-release alfuzosin 2.5mg three times daily (6.3 vs 9.4%). A similar incidence of vasodilatory adverse events was observed in patients aged ≥65 years and those aged ≤65 years receiving prolonged-release alfuzosin 10mg once daily. The most common adverse events in clinical trials were dizziness, asthenia and fatigue.

Prolonged-release alfuzosin 10mg once daily did not cause clinically relevant changes to blood pressure compared with baseline, and changes did not appear to be influenced by age. Supine systolic and diastolic blood pressure decreased slightly in patients treated with all formulations of alfuzosin and a greater decrease was observed in patients with hypertension than in patients with normal blood pressure. However, changes were not clinically significant, nor did they differ significantly from those observed in patients receiving placebo.

The incidence of ejaculatory disorders was <1% in patients receiving prolonged-release alfuzosin 10mg once daily.

Over a 12-month period of treatment with the once-daily 10mg formulation of alfuzosin, vasodilatory adverse effects were reported by 4.4% of patients and in 1.1 % of the total patient group they led to discontinuation of treatment. Asymptomatic orthostatic hypotension was observed in 2.8% of patients and there did not appear to be an increased risk for patients receiving concomitant antihypertensives.

Dosage titration is not required with prolonged-release alfuzosin 10mg once daily as it is not associated with first-day effects compared with placebo.

Dosage and Administration

Prolonged-release alfuzosin is indicated for the treatment of symptoms associated with BPH and the recommended dosage is for one 10mg tablet to be taken daily (swallowed whole) after a meal. The absence of a first-day effect enables a full therapeutic dose to be given from the first day of treatment.

Alfuzosin is contraindicated in combination with other α1-adrenoceptor antagonists, and in patients with orthostatic hypotension or hepatic insufficiency. As with all ai-adrenoceptor antagonists, there is the potential for postural hypotension to develop within a few hours of administration, with or without symptoms (dizziness, fatigue, sweating). Effects usually occur early in treatment and do not necessitate therapy withdrawal. In patients with coronary artery disease, alfuzosin should be discontinued if symptoms of angina reappear or get worse.

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Authors and Affiliations

  1. Adis International Limited, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland 10, New Zealand

    Kate McKeage & Greg L. Plosker

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Correspondence to Kate McKeage.

Additional information

Various sections of the manuscript reviewed by: C. R. Chapple, Central Sheffield University Hospital, Sheffield, United Kingdom; C. de Mey, Applied Clinical Pharmacology Services, Mainz-Kastel, Germany; A. Kaisary, Royal Free Hospital, London, United Kingdom; T. Tammela, Division of Urology, Tampere University Hospital, Tampere, Finland; A McNeill, Department of Urology, Western General Hospital, Edinburgh, United Kingdom

Data Selection

Data Selection Sources: Medical literature published in any language since 1983 on alfuzosin, identified using AdisBase (a proprietary database of Adis International), Medline and EMBASE. Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: AdisBase search terms were ‘alfuzosin’ and ‘benign-prostatic-hyperplasia’ or ‘alfuzosin PK/PD’. Medline search terms were ‘alfuzosin’ and ‘prostatic-hyperplasia’. EMBASE search terms were ‘alfuzosin’ or ‘SL 77499’ and ‘prostate-hypertrophy’. Searches were last updated 3 January 2002.

Selection: Studies in patients with benign prostatic hyperplasia who received prolonged-release alfuzosin 10mg. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Alfuzosin, benign prostatic hyperplasia, pharmacodynamics, pharmacokinetics, therapeutic use.

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McKeage, K., Plosker, G.L. Alfuzosin. Drugs 62, 633–653 (2002). https://doi.org/10.2165/00003495-200262040-00009

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