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[Doxazosin in the gastrointestinal therapeutic system (GITS) and doxazosin standard in patients with benign prostatic hyperplasia. Double-blind trial of efficacy and tolerability].
Fortschr Med Orig. 2000 Jul 27; 118 Suppl 2:83-92.FM

Abstract

BACKGROUND AND METHOD

This randomized, doubleblind, multicenter, parallel-group, placebo-baseline study compared the effects of doxazosin GITS 4 mg or 8 mg once daily with doxazosin standard 1 mg to 8 mg once daily in 678 men with benign prostatic hyperplasia (BPH). Following a 2-week washout period and a 2-week, single-blind, placebo run-in phase, patients were randomized to 13 weeks of double-blind treatment with doxazosin GITS, initiated at 4 mg once daily and titrated to 8 mg once daily after 7 weeks, if needed, and doxazosin standard, initiated at 1 mg once daily, titrated to 2 mg after 1 week, to 4 mg at 3 weeks, and to 8 mg at 7 weeks if needed. The primary outcome measures were mean changes from baseline to the final visit for International Prostate Symptom Score (I-PSS) and maximum urinary flow rate in the per-protocol analysis (PPA) population. Secondary outcomes included other aspects of BPH symptoms and urinary flow; and assessment of sexual function in the PPA and intent-to-treat populations, as measured by the International Index of Erectile Function (IIEF).

RESULTS

Doxazosin GITS and doxazosin standard produced clinically and statistically significant equivalent reductions in BPH symptoms, including least-square mean decreases in total I-PSS of -8.1 +/- 0.3 and -7.9 +/- 0.3 from baseline, respectively (p < 0.001 vs baseline for each). Both therapies significantly improved maximum urinary flow rates by 2.7 +/- 0.3 ml/s (least-squares mean change from baseline, p < 0.001). The beneficial effects of both therapies on secondary parameters of symptoms and urinary flow were consistent with these findings. Significant improvements in sexual function were observed with both therapies among individuals with sexual dysfunction at baseline. Nearly half of patients on doxazosin GITS achieved BPH symptom relief at the initial 4-mg dose.A similar number of patients in both doxazosin groups were titrated to the maximum dose of 8 mg for both formulations. While both agents were well tolerated, the incidence of at least one treatment-emergent adverse event was significantly lower among patients treated with doxazosin GITS (p = 0.003).

CONCLUSIONS

Doxazosin GITS and doxazosin standard produced comparable significant reductions in BPH symptoms and improvements in maximum urinary flow rates. A therapeutic effect equivalent to that of doxazosin standard was achieved with doxazosin GITS with fewer titration steps and enhanced tolerability. Both formulations of doxazosin improved sexual function in individuals with dysfunction at baseline.

Authors+Show Affiliations

St. George's Hospital, Universität London, GB.No affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase II
Clinical Trial, Phase III
Comparative Study
English Abstract
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

ger

PubMed ID

15700491

Citation

Gratzke, P, and R S. Kirby. "[Doxazosin in the Gastrointestinal Therapeutic System (GITS) and Doxazosin Standard in Patients With Benign Prostatic Hyperplasia. Double-blind Trial of Efficacy and Tolerability]." Fortschritte Der Medizin. Originalien, vol. 118 Suppl 2, 2000, pp. 83-92.
Gratzke P, Kirby RS. [Doxazosin in the gastrointestinal therapeutic system (GITS) and doxazosin standard in patients with benign prostatic hyperplasia. Double-blind trial of efficacy and tolerability]. Fortschr Med Orig. 2000;118 Suppl 2:83-92.
Gratzke, P., & Kirby, R. S. (2000). [Doxazosin in the gastrointestinal therapeutic system (GITS) and doxazosin standard in patients with benign prostatic hyperplasia. Double-blind trial of efficacy and tolerability]. Fortschritte Der Medizin. Originalien, 118 Suppl 2, 83-92.
Gratzke P, Kirby RS. [Doxazosin in the Gastrointestinal Therapeutic System (GITS) and Doxazosin Standard in Patients With Benign Prostatic Hyperplasia. Double-blind Trial of Efficacy and Tolerability]. Fortschr Med Orig. 2000 Jul 27;118 Suppl 2:83-92. PubMed PMID: 15700491.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Doxazosin in the gastrointestinal therapeutic system (GITS) and doxazosin standard in patients with benign prostatic hyperplasia. Double-blind trial of efficacy and tolerability]. AU - Gratzke,P, AU - Kirby,R S, PY - 2005/2/11/pubmed PY - 2005/3/4/medline PY - 2005/2/11/entrez SP - 83 EP - 92 JF - Fortschritte der Medizin. Originalien JO - Fortschr Med Orig VL - 118 Suppl 2 N2 - BACKGROUND AND METHOD: This randomized, doubleblind, multicenter, parallel-group, placebo-baseline study compared the effects of doxazosin GITS 4 mg or 8 mg once daily with doxazosin standard 1 mg to 8 mg once daily in 678 men with benign prostatic hyperplasia (BPH). Following a 2-week washout period and a 2-week, single-blind, placebo run-in phase, patients were randomized to 13 weeks of double-blind treatment with doxazosin GITS, initiated at 4 mg once daily and titrated to 8 mg once daily after 7 weeks, if needed, and doxazosin standard, initiated at 1 mg once daily, titrated to 2 mg after 1 week, to 4 mg at 3 weeks, and to 8 mg at 7 weeks if needed. The primary outcome measures were mean changes from baseline to the final visit for International Prostate Symptom Score (I-PSS) and maximum urinary flow rate in the per-protocol analysis (PPA) population. Secondary outcomes included other aspects of BPH symptoms and urinary flow; and assessment of sexual function in the PPA and intent-to-treat populations, as measured by the International Index of Erectile Function (IIEF). RESULTS: Doxazosin GITS and doxazosin standard produced clinically and statistically significant equivalent reductions in BPH symptoms, including least-square mean decreases in total I-PSS of -8.1 +/- 0.3 and -7.9 +/- 0.3 from baseline, respectively (p < 0.001 vs baseline for each). Both therapies significantly improved maximum urinary flow rates by 2.7 +/- 0.3 ml/s (least-squares mean change from baseline, p < 0.001). The beneficial effects of both therapies on secondary parameters of symptoms and urinary flow were consistent with these findings. Significant improvements in sexual function were observed with both therapies among individuals with sexual dysfunction at baseline. Nearly half of patients on doxazosin GITS achieved BPH symptom relief at the initial 4-mg dose.A similar number of patients in both doxazosin groups were titrated to the maximum dose of 8 mg for both formulations. While both agents were well tolerated, the incidence of at least one treatment-emergent adverse event was significantly lower among patients treated with doxazosin GITS (p = 0.003). CONCLUSIONS: Doxazosin GITS and doxazosin standard produced comparable significant reductions in BPH symptoms and improvements in maximum urinary flow rates. A therapeutic effect equivalent to that of doxazosin standard was achieved with doxazosin GITS with fewer titration steps and enhanced tolerability. Both formulations of doxazosin improved sexual function in individuals with dysfunction at baseline. UR - https://www.unboundmedicine.com/medline/citation/15700491/[Doxazosin_in_the_gastrointestinal_therapeutic_system__GITS__and_doxazosin_standard_in_patients_with_benign_prostatic_hyperplasia__Double_blind_trial_of_efficacy_and_tolerability]_ L2 - http://www.diseaseinfosearch.org/result/9668 DB - PRIME DP - Unbound Medicine ER -