Long-term treatment with doxazosin in men with benign prostatic hyperplasia: 10-year follow-up

INTRODUCTION AND OBJECTIVES: Benign prostatic hyperplasia (BPH) is a progressive condition that is characterized by an increased risk of acute urinary retention and BPH-related surgery. This study evaluates the safety and efficacy of doxazosin over 10 years in men with BPH. MATERIAL AND METHODS: The trial enrolled men (aged 49-83 years--mean 64.0) with symptomatic BPH (clinical stage II according to Alken) and no evidence of prostate cancer. The trial involved a 1.5 year controlled efficacy study with doxazosin (4 mg/day) 64 ambulatory patients with BPH, followed by a 5-year extension. During the study after 1 year 11 pts discontinued it (expense given as reason) and 6 pts underwent surgery. Then 47 pts (100%) receiving doxazosin continued therapy. After 5 years 32 pts (60%) aged 54-92 years--mean 69.4 years continued to be followed for further 5 years, giving a total follow-up of 10 years (next 8 pts underwent surgery; total 14 (26%) pts; and 14 (26%) pts died. RESULTS: Twenty (38%) of the 47 pts (100%) enrolled into doxazosin were judged as being successfully treated during the 10-year follow-up. In further 5 years only 2 pts underwent surgery and 7 pts (13%) died for reasons unrelated to doxazosin treatment. Three pts after 6 years therapy left study. Excluding 14 pts who died plus 14 pts who left the trial it means that after 10 years 20 pts remained successfully treated and 16 pts who had to be surgically treated. Assuming that all group make 36 pts (100%) than long term follow-up showed effective results in doxazosin treated 20 pts (56%) and thus can obviate surgery. Adverse events associated with doxazosin therapy were insignificant. 10 years therapy proved effective in increasing urina flow rates and decreasing residual urine volume--respectively 14.6 ml/s and 57.0 ml (mean value). CONCLUSIONS: 1. Long-term 10 years doxazosin (4 mg/daily) therapy has demonstrated that appropriately selected BPH patients are likely to have an excellent response. 2. The a/m trial indicates that surgery can be obviated in up to half of BPH treated patients. 3. The results of the trial demonstrate that doxazosin is safe, efficacious and well-tolerated.