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AN OPEN STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF DOXAZOSIN IN THE SYMPTOMATIC TREATMENT OF BENIGN PROSTATIC HYPERPLASIA
Abstract
*A. Abdel Aziz, M.D.; I. Abdel-Hafeez, M.D.;A. Abdel-Hakim, M.D.; M. Abdel-Malek, M.D.; A. Abdel-Meguid, M.D.; M. Abo-Elhassan, M.D.; U. Abo-Farha, M.D.; M. Abo-Guindy, M.D.; A. Arafa, M.D.; A. Ashamallah, M.D.; A. Baghat, M.D.; M. Elakkad, M.D.; H. El-Bialy, M.D.; H. El-Damanhoury, M.D.; M.Eldomairy, M.D.; A.Elkasaby, M.D.; A. Gaafar, M.D.; M. Gaballah, M.D.; B. Hathut, M.D.; A. Ibrahim, M.D.; I. Khalaf, M.D.; M. Moaatamed, M.D.; Sh. Morad, M.D.; R. Moustafa, M.D.; M. Rafik, M.D.; M. Abdel-Azeem, M.D.; H. Rashwan, M.D.;S. Mohamed, M.D.; A. Salama, M.D.; M. Shalaby, M.D.; I. Shoukry, M.D.; H. Torky, M.D.
Objectives To assess the efficacy and safety of doxazosin, a selective 1-adrenoceptor antagonist, in the treatment of benign prostatic hyperplasia (BPH).
Patients and Methods A total of 333 patients, 50 years or older, were included in this 12-week, multicenter (30 investigational sites), baseline placebo-controlled study. The diagnosis was based on clinical manifestations, digital rectal examination and uroflowmetry. The treatment duration included a 2-week placebo washout phase and a 12-week active treatment phase (6 visits). Twenty-one patients were lost to follow-up during the placebo run-in phase and 312 patients completed the study. During the active treatment phase, the starting dose was 1 mg/day for 2 weeks that was titrated to 2 mg/day for 5 weeks. Titration was further increased to 4 mg/day when there was no increase in the peak flow rate (Qmax) ³ 3 ml/sec and/or no reduction in the mean International Prostate Symptoms Score (IPSS) ³ 30%. The blood pressure was assessed at baseline and at each subsequent visit.
Results At the end of the treatment phase, doxazosin showed a remarkable effect on the efficacy parameters with IPSS improving from 19.55 ± 5.27 to 9.25 ± 3.77 (p < 0.0001). The peak flow rate (Qmax) increased from 8.92 ± 3.51 to 13.27 ± 7.41 (p < 0.0001) and the average mean flow (Qmean) rate increased from 4.56 ± 2.53 to 6.65 ± 5.85 (p < 0.0001). Doxazosin caused a mean reduction in blood pressure in hypertensive patients (n=131) of 13.5 / 7.5 mmHg (p < 0.0001), while clinically insignificant changes were observed in the blood pressure of normotensive patients (n=181). In those patients the mean reduction in blood pressure was 4.2 / 2.5 mmHg (p<0.0001). Adverse events were experienced by 24 patients (7.69%) in the form of heachache, dizziness, fatigue and somnolence, which were generally mild to moderate in intensity. Only 4 patients (1.28%) were withdrawn due to side effects (dizziness, somnolence or fatigue).
Conclusion Doxazosin is an effective agent for the treatment of BPH and is well tolerated by the majority of patients.
African Journal of Urology Vol. 7 No. 3 (Sept 2001): pp 94-102
Objectives To assess the efficacy and safety of doxazosin, a selective 1-adrenoceptor antagonist, in the treatment of benign prostatic hyperplasia (BPH).
Patients and Methods A total of 333 patients, 50 years or older, were included in this 12-week, multicenter (30 investigational sites), baseline placebo-controlled study. The diagnosis was based on clinical manifestations, digital rectal examination and uroflowmetry. The treatment duration included a 2-week placebo washout phase and a 12-week active treatment phase (6 visits). Twenty-one patients were lost to follow-up during the placebo run-in phase and 312 patients completed the study. During the active treatment phase, the starting dose was 1 mg/day for 2 weeks that was titrated to 2 mg/day for 5 weeks. Titration was further increased to 4 mg/day when there was no increase in the peak flow rate (Qmax) ³ 3 ml/sec and/or no reduction in the mean International Prostate Symptoms Score (IPSS) ³ 30%. The blood pressure was assessed at baseline and at each subsequent visit.
Results At the end of the treatment phase, doxazosin showed a remarkable effect on the efficacy parameters with IPSS improving from 19.55 ± 5.27 to 9.25 ± 3.77 (p < 0.0001). The peak flow rate (Qmax) increased from 8.92 ± 3.51 to 13.27 ± 7.41 (p < 0.0001) and the average mean flow (Qmean) rate increased from 4.56 ± 2.53 to 6.65 ± 5.85 (p < 0.0001). Doxazosin caused a mean reduction in blood pressure in hypertensive patients (n=131) of 13.5 / 7.5 mmHg (p < 0.0001), while clinically insignificant changes were observed in the blood pressure of normotensive patients (n=181). In those patients the mean reduction in blood pressure was 4.2 / 2.5 mmHg (p<0.0001). Adverse events were experienced by 24 patients (7.69%) in the form of heachache, dizziness, fatigue and somnolence, which were generally mild to moderate in intensity. Only 4 patients (1.28%) were withdrawn due to side effects (dizziness, somnolence or fatigue).
Conclusion Doxazosin is an effective agent for the treatment of BPH and is well tolerated by the majority of patients.
African Journal of Urology Vol. 7 No. 3 (Sept 2001): pp 94-102
