Résumé
PURPOSE: We compared the efficacy and safety profiles of dose increase, traditional combination methods, and combining different alpha blockers in hypertensive males with lower urinary tract symptom (LUTS) refractory to an initial dose of 4 mg doxazosin. MATERIALS AND METHODS: Between 2000 and 2005, 374 male patients with LUTS and hypertension unresponsive to 4 weeks of 4 mg doxazosin were enrolled. The subjects were randomly classified into 3 groups, 8 mg/day of doxazosin (D group), 4 mg of doxazosin plus 0.2 mg/day of tamsulosin (DT group), and 4 mg doxazosin plus 5 mg/day finasteride (DF group). Patients were evaluated based on their International Prostate Symptom Score (IPSS), quality of life (QOL), uroflowmetry and blood pressure (BP) and adverse events (AEs) at the baseline and 3 and 12 months after treatment. RESULTS: The 269 patients (71.9%) were followed for at least 1 year (D group n=84, DT group n=115, and DF group n=70). The clinical parameters before and after initial 4 mg/day doxazosin were not different among the 3 groups. IPSS improvement after 3 months and maximal flow rate (Qmax) improvement after 3 and 12 months were significantly higher in the D and DT groups than the DF group (p<0.05). Sitting systolic and diastolic BP of the D group decreased larger than those of the other 2 groups (p<0.05). At least one of the AEs was reported by 29.0%, 19.3%, and 17.3% of patients in the D, DT, and DF groups, respectively. In particular, vasodilatory AEs of the D group (28.2%) were higher than those of other groups (p<0.05), and sexual function AEs of the DF group (10.9%) were higher than those of other groups (p<0.05). CONCLUSIONS: Doxazosin 4 mg plus tamsulosin 0.2 mg has comparable efficacy but less vasodilatory AEs than doxazosin 8 mg, and has superior efficacy to but comparable vasodilatory AEs to 4 mg doxazosin plus 5 mg finasteride in hypertensive male LUTS patients.