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Traditionally, drug therapy for benign prostatic hyperplasia (BPH) has been reserved for patients with mild or moderate symptoms. The objective of this analysis was to compare responses to an alpha 1-adrenergic receptor blocker, doxazosin, in patients with severe, intermediate, and mild disease. Data were analyzed from patients with symptomatic BPH who were enrolled in two 16-week, double-masked, placebo-controlled studies of doxazosin. In study 1, 163 hypertensive patients were stratified according to baseline maximum (Qmax) and mean (Qmean) urinary flow rate as having severe, intermediate, or mild disease. In study 2, 82 normotensive patients were stratified according to their baseline American Urological Association (AUA) BPH symptom severity score and modified Boyarsky symptom bothersomeness score. Overall, doxazosin was significantly more effective than placebo in improving Qmax and Qmean in study 1 and in improving the AUA-derived and modified Boyarsky scores in study 2. There were statistically significant differences in the response to treatment, as represented by Qmax' Qmean, and modified Boyarsky score, between patients with severe, intermediate, and mild disease. There were no significant differences in the AUA-derived scores of patients in the three severity groups. These results have important clinical implications, suggesting that the majority of BPH patients are candidates for a course of drug therapy, regardless of baseline disease status.

The urinary symptoms characteristic of benign prostatic hyperplasia (BPH) can have a considerable impact on patients' quality of life. Symptom score assessment is now used in BPH, although a number of different instruments are available. Controlled clinical trials with selective alpha 1 adrenoceptor antagonists such as doxazosin, prazosin and terazosin have shown these agents to be effective in the treatment of BPH. The effects of doxazosin on the severity and bothersomeness of BPH symptoms were determined in three multicentre, double-blind, placebo-controlled clinical studies, involving a total of 609 normotensive and hypertensive patients. Doxazosin was initiated at a dosage of 0.5 or 1 mg once daily, with a final dose range of up to 12 mg once daily. The duration of active treatment was 12 to 14 weeks. Significant improvements were seen in symptom severity and bothersomeness with doxazosin compared with placebo, in both patient populations. The onset of symptomatic improvement was rapid, occurring within two weeks of treatment initiation, and efficacy was sustained throughout the treatment period. A long-term, open label extension of these studies has demonstrated sustained efficacy during 48 months of follow-up. Since symptom relief is the primary goal of therapy in BPH, and since doxazosin's effects are rapid in onset and sustained in duration, it appears that doxazosin is an effective agent for the treatment of symptomatic BPH in both normotensive and hypertensive men.

Purpose: We evaluated the sustained efficacy and safety of doxazosin for long-term treatment (up to 48 months) of normotensive and hypertensive patients with benign prostatic hyperplasia (BPH)., Materials and Methods: A total of 272 normotensive and 178 mildly to moderately hypertensive men entered a long-term extension study of doxazosin therapy (1 to 8 and 1 to 12 mg. 1 time daily, respectively) for BPH following participation in double-blind, placebo controlled studies. The starting dose of doxazosin was 1 mg. with upward titrations at 2-week intervals to a stable, efficacious and well tolerated dose. At the time of data analysis patients had received between 1 and 48 months of stable dose doxazosin therapy (mean 668 days for normotensive and 807 for hypertensive patients). Mean daily doses were 4 and 6.4 mg. for normotensive and hypertensive men, respectively., Results: At the end point analysis doxazosin treatment resulted in significant increases above baseline in maximum and average urinary flow rates (1.9 and 1.0 ml. per second, respectively). As assessed by the patient, total, obstructive and irritative BPH symptoms also improved significantly with doxazosin treatment. In the 28 patients who completed 45 to 48 months of treatment improvement in symptom bothersomeness (13.2%) was similar to that of the overall group at the end point (14.8%). Sustained blood pressure decreases (approximately 8/11 mm. Hg systolic/diastolic blood pressure) with doxazosin were statistically and clinically significant in hypertensive patients. Blood pressure decreases in normotensive patients were not clinically significant (approximately 4/2 mm. Hg) and few withdrew from study for reasons related directly to decreased blood pressure or hypotension. Changes in heart rate were not significant. Doxazosin was well tolerated with almost 90% of adverse experiences considered mild or moderate in severity. The most common adverse events were dizziness, headache and fatigue in normotensive and hypertensive patients., Conclusions: In this study long-term doxazosin treatment was significantly effective and well tolerated for treating BPH in normotensive and hypertensive patients.