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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.

AbstractOBJECTIVES:
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.
AuthorsP van Kerrebroec, A Jardin, P van Cangh, K U Laval,
JournalEuropean urology (Eur Urol) Vol. 41 Issue 1 Pg. 54-60; discussion 60-1 (Jan 2002) ISSN: 0302-2838 [Print] Netherlands
PMID11999466 (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

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