Long-term safety and efficacy of a once-daily formulation of alfuzosin 10 mg in patients with symptomatic benign prostatic hyperplasia: open-label extension study.

Abstract

OBJECTIVES:

To evaluate the long-term safety and efficacy of a new, once-daily (o.d.) prolonged-release formulation of the clinically uroselective alpha1-blocker, alfuzosin, in patients with symptomatic benign prostatic hyperplasia (BPH).

METHODS:

This is a 9-month open-label extension of a 3-month double-blind, placebo-controlled evaluation of alfuzosin 10 mg o.d. and standard alfuzosin 2.5 mg, three times daily (t.i.d.), administered without dose titration in both cases. A total of 311 patients continued in the extension phase and all received alfuzosin 10 mg o.d. Efficacy was evaluated in all patients enrolled in the extension phase (n = 311). Safety was assessed in all patients exposed to alfuzosin, whether in the double-blind or extension phase (n = 360).

RESULTS:

Mean international prostate symptom score (IPSS) improved significantly, from 17.1 to 9.3 (P < 0.0001), and mean peak flow rate (PFR) (assessed at through plasma levels) increased significantly, from 9.1 to 11.3 ml/s (P < 0.0001), between baseline (i.e. beginning of the double-blind phase) and the endpoint of the extension phase. Quality of life (QOL) index also improved significantly, from 3.3 to 2.1 (P < 0.0001). Alfuzosin was well tolerated, with only 16 of 360 patients (4.4%) reporting adverse events potentially related to alpha-blockade (mainly dizziness). Ejaculation disorders were infrequent (0.6%) and did not show a relationship to treatment. The incidence of asymptomatic orthostatic hypotension was low (2.8%), and no age effect was identified.

CONCLUSIONS:

Alfuzosin 10 mg o.d. provides effective relief from BPH, and clinical benefits are maintained up to 12 months. This study also demonstrates the satisfactory long-term safety of this formulation, and its safe use even in at-risk populations.

• Authors: P van Kerrebroec, A Jardin, P van Cangh, K U Laval, ALFORTI Study Group
• Journal: European urology (Eur Urol) Vol. 41 Issue 1 Pg. 54-60; discussion 60-1 (Jan 2002) ISSN: 0302-2838 [Print] Switzerland
• PMID: 11999466 (Publication Type: Clinical Trial, Comparative Study, Journal Article)

Chemical References

• Adrenergic alpha-Antagonists
• Delayed-Action Preparations
• Quinazolines
• alfuzosin

Topics

• Adrenergic alpha-Antagonists (administration & dosage, adverse effects)
• Aged
• Aged, 80 and over
• Delayed-Action Preparations (administration & dosage)
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Evaluation Studies as Topic
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Probability
• Prostatic Hyperplasia (drug therapy, pathology)
• Quinazolines (administration & dosage, adverse effects)
• Severity of Illness Index
• Treatment Outcome