Safety and efficacy of alfuzosin 10 mg once-daily in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies

BJU Int. 2003 Aug;92(3):257-61. doi: 10.1046/j.1464-410x.2003.04309.x.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adrenergic alpha-Antagonists / administration & dosage*
  • Adrenergic alpha-Antagonists / adverse effects
  • Adult
  • Aged
  • Aged, 80 and over
  • Double-Blind Method
  • Erectile Dysfunction / chemically induced
  • Humans
  • Male
  • Middle Aged
  • Prostatic Hyperplasia / drug therapy*
  • Quinazolines / administration & dosage*
  • Quinazolines / adverse effects
  • Sexual Dysfunction, Physiological / chemically induced
  • Treatment Outcome
  • Urinary Retention / drug therapy*


  • Adrenergic alpha-Antagonists
  • Quinazolines
  • alfuzosin