Controlled-release doxazosin in the treatment of benign prostatic hyperplasia

Hernández, Carlos; Durán, Ramón; Jara, José; Castaño, I Martínez; Moralejo, M.

doi:10.1038/sj.pcan.4500820

Cited by 7 publications

(1 citation statement)

References 25 publications

(21 reference statements)

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“…Moreover, curative levels can be achieved more rapidly with this formulation without the addition of excessive titration steps [3]. Doxazosin GITS has demonstrated efficacy, particularly for improvement of symptom scores and increase in maximum urinary flow (Qmax), as well as demonstrating benefits on quality of life (QoL) [4,5]. The efficacy and tolerability of 4-mg and 8-mg single doses of doxazosin GITS have been compared with a single dose of 1 mg immediate release doxazosin in subjects with mild-to-moderate hypertension, which results in similar outcomes [2].…”

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Efficacy and Safety of the Doxazosin Gastrointestinal Therapeutic System for the Treatment of Benign Prostate Hyperplasia

Sun

Tsui

et al. 2010

The Kaohsiung J of Med Scie

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This study was carried out to obtain information on the efficacy and safety of the controlled release formulation of the doxazosin Gastrointestinal Therapeutic System (GITS) in Taiwanese subjects with benign prostatic hyperplasia (BPH). Studies of doxazosin in Asian populations for this indication have lacked data particularly from Taiwan. This was an 8-week, post-marketing, open-label, non-comparative study. Eighty male subjects (mean age=64 years) with BPH received doxazosin GITS 4 mg once daily. At week 4, subjects who achieved an increase in maximum urinary flow rate (Qmax) of ≥3mL/s and a ≥30% reduction in the total International Prostate Symptom Score (IPSS) continued on doxazosin GITS 4 mg for the remaining 4 weeks; all other subjects were up-titrated to 8 mg once daily. Change from baseline at weeks 4 and 8 (primary endpoint) in IPSS and Qmax was evaluated using two-sided paired t tests for the intent-to-treat population. Safety was assessed throughout the study. A total of 53 (66.3%) subjects completed the study. Baseline Qmax and IPSS were 10.7+3.4 mL/s and 20.6+5.4, respectively. At week 8, a significant increase from baseline in Qmax of 3.3+4.6 mL/s (95% confidence interval = 2.2-4.4, p< 0.001) and a significant decrease in total IPSS of -8.9 + 7.0 (95% confidence interval=-10.5 to -7.3, p< 0.001) was observed. The most common treatment-related adverse event was dizziness. Doxazosin GITS 4 mg per day (with an 8-mg titration step) effectively improved symptoms of BPH. The results from this study provide further information for clinicians on the use of doxazosin GITS for the treatment of BPH, particularly in Taiwanese patients.

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