A double-blind placebo-controlled study evaluating the onset of action of doxazosin gastrointestinal therapeutic system in the treatment of benign prostatic hyperplasia

Claus Roehrborn, Andrzej Prajsner, Roger Kirby, Morton Andersen, Sheila Quinn, Sharon Mallen

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Objective: To determine the onset of improvement in benign prostatic hyperplasia symptoms in patients after treatment with doxazosin gastrointestinal therapeutic system (DOX GITS) versus placebo. Methods: In this prospective, randomized, double-blind, placebo-controlled trial, baseline values, including International Prostate Symptom Score (IPSS) and maximum urine flow rate (Q max), were determined following a 2-week placebo run-in. Patients received DOX GITS 4 mg/d (n = 108) or placebo (n = 105) for 14 days. IPSS was measured on Days 3, 7, and 14; Qmax on Days 1, 3, 7, and 14; and the patients' perception of improvement was measured on Days 1 and 2 in the evening at home and in the office on Day 14. Results: Significantly more patients treated with DOX GITS than placebo perceived improvement after Day 1 (60.6% vs. 41.9%) through Day 14 (84.3% vs. 64.1%). On Day 1, improvement in Q max with DOX GITS was not significantly different compared with placebo. On Day 3 of the trial (1) IPSS improvement was significantly greater with DOX GITS than with placebo; (2) proportion of patients with ≥30% improvement in IPSS was significantly greater with DOX GITS (49.5%) than placebo (28.4%) and remained so through Day 14; (3) improvement in Qmax was significantly greater with DOX GITS (3.7 mL/s) than placebo (1.9 mL/s) and remained so through Day 14; (4) proportion of patients with ≥3 mL/s increase in Qmax was statistically greater with DOX GITS (54.4%) versus placebo (30.8%) and remained so through Day 14. Conclusions: DOX GITS significantly improved IPSS and Qmax by Day 3 of treatment, and these changes were maintained through Day 14. More patients receiving DOX GITS than placebo perceived improvement in symptoms as early as Day 1.

Original languageEnglish (US)
Pages (from-to)445-452
Number of pages8
JournalEuropean Urology
Volume48
Issue number3
DOIs
StatePublished - Sep 2005

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Doxazosin
Prostatic Hyperplasia
Placebos
Prostate
Therapeutics

Keywords

  • Benign prostatic hyperplasia
  • Doxazosin
  • GITS
  • Lower urinary tract symptoms

ASJC Scopus subject areas

  • Urology

Cite this

A double-blind placebo-controlled study evaluating the onset of action of doxazosin gastrointestinal therapeutic system in the treatment of benign prostatic hyperplasia. / Roehrborn, Claus; Prajsner, Andrzej; Kirby, Roger; Andersen, Morton; Quinn, Sheila; Mallen, Sharon.

In: European Urology, Vol. 48, No. 3, 09.2005, p. 445-452.

Research output: Contribution to journalArticle

Roehrborn, Claus ; Prajsner, Andrzej ; Kirby, Roger ; Andersen, Morton ; Quinn, Sheila ; Mallen, Sharon. / A double-blind placebo-controlled study evaluating the onset of action of doxazosin gastrointestinal therapeutic system in the treatment of benign prostatic hyperplasia. In: European Urology. 2005 ; Vol. 48, No. 3. pp. 445-452.
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abstract = "Objective: To determine the onset of improvement in benign prostatic hyperplasia symptoms in patients after treatment with doxazosin gastrointestinal therapeutic system (DOX GITS) versus placebo. Methods: In this prospective, randomized, double-blind, placebo-controlled trial, baseline values, including International Prostate Symptom Score (IPSS) and maximum urine flow rate (Q max), were determined following a 2-week placebo run-in. Patients received DOX GITS 4 mg/d (n = 108) or placebo (n = 105) for 14 days. IPSS was measured on Days 3, 7, and 14; Qmax on Days 1, 3, 7, and 14; and the patients' perception of improvement was measured on Days 1 and 2 in the evening at home and in the office on Day 14. Results: Significantly more patients treated with DOX GITS than placebo perceived improvement after Day 1 (60.6{\%} vs. 41.9{\%}) through Day 14 (84.3{\%} vs. 64.1{\%}). On Day 1, improvement in Q max with DOX GITS was not significantly different compared with placebo. On Day 3 of the trial (1) IPSS improvement was significantly greater with DOX GITS than with placebo; (2) proportion of patients with ≥30{\%} improvement in IPSS was significantly greater with DOX GITS (49.5{\%}) than placebo (28.4{\%}) and remained so through Day 14; (3) improvement in Qmax was significantly greater with DOX GITS (3.7 mL/s) than placebo (1.9 mL/s) and remained so through Day 14; (4) proportion of patients with ≥3 mL/s increase in Qmax was statistically greater with DOX GITS (54.4{\%}) versus placebo (30.8{\%}) and remained so through Day 14. Conclusions: DOX GITS significantly improved IPSS and Qmax by Day 3 of treatment, and these changes were maintained through Day 14. More patients receiving DOX GITS than placebo perceived improvement in symptoms as early as Day 1.",
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AU - Andersen, Morton

AU - Quinn, Sheila

AU - Mallen, Sharon

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N2 - Objective: To determine the onset of improvement in benign prostatic hyperplasia symptoms in patients after treatment with doxazosin gastrointestinal therapeutic system (DOX GITS) versus placebo. Methods: In this prospective, randomized, double-blind, placebo-controlled trial, baseline values, including International Prostate Symptom Score (IPSS) and maximum urine flow rate (Q max), were determined following a 2-week placebo run-in. Patients received DOX GITS 4 mg/d (n = 108) or placebo (n = 105) for 14 days. IPSS was measured on Days 3, 7, and 14; Qmax on Days 1, 3, 7, and 14; and the patients' perception of improvement was measured on Days 1 and 2 in the evening at home and in the office on Day 14. Results: Significantly more patients treated with DOX GITS than placebo perceived improvement after Day 1 (60.6% vs. 41.9%) through Day 14 (84.3% vs. 64.1%). On Day 1, improvement in Q max with DOX GITS was not significantly different compared with placebo. On Day 3 of the trial (1) IPSS improvement was significantly greater with DOX GITS than with placebo; (2) proportion of patients with ≥30% improvement in IPSS was significantly greater with DOX GITS (49.5%) than placebo (28.4%) and remained so through Day 14; (3) improvement in Qmax was significantly greater with DOX GITS (3.7 mL/s) than placebo (1.9 mL/s) and remained so through Day 14; (4) proportion of patients with ≥3 mL/s increase in Qmax was statistically greater with DOX GITS (54.4%) versus placebo (30.8%) and remained so through Day 14. Conclusions: DOX GITS significantly improved IPSS and Qmax by Day 3 of treatment, and these changes were maintained through Day 14. More patients receiving DOX GITS than placebo perceived improvement in symptoms as early as Day 1.

AB - Objective: To determine the onset of improvement in benign prostatic hyperplasia symptoms in patients after treatment with doxazosin gastrointestinal therapeutic system (DOX GITS) versus placebo. Methods: In this prospective, randomized, double-blind, placebo-controlled trial, baseline values, including International Prostate Symptom Score (IPSS) and maximum urine flow rate (Q max), were determined following a 2-week placebo run-in. Patients received DOX GITS 4 mg/d (n = 108) or placebo (n = 105) for 14 days. IPSS was measured on Days 3, 7, and 14; Qmax on Days 1, 3, 7, and 14; and the patients' perception of improvement was measured on Days 1 and 2 in the evening at home and in the office on Day 14. Results: Significantly more patients treated with DOX GITS than placebo perceived improvement after Day 1 (60.6% vs. 41.9%) through Day 14 (84.3% vs. 64.1%). On Day 1, improvement in Q max with DOX GITS was not significantly different compared with placebo. On Day 3 of the trial (1) IPSS improvement was significantly greater with DOX GITS than with placebo; (2) proportion of patients with ≥30% improvement in IPSS was significantly greater with DOX GITS (49.5%) than placebo (28.4%) and remained so through Day 14; (3) improvement in Qmax was significantly greater with DOX GITS (3.7 mL/s) than placebo (1.9 mL/s) and remained so through Day 14; (4) proportion of patients with ≥3 mL/s increase in Qmax was statistically greater with DOX GITS (54.4%) versus placebo (30.8%) and remained so through Day 14. Conclusions: DOX GITS significantly improved IPSS and Qmax by Day 3 of treatment, and these changes were maintained through Day 14. More patients receiving DOX GITS than placebo perceived improvement in symptoms as early as Day 1.

KW - Benign prostatic hyperplasia

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