DOXAZOSIN FOR BENIGN PROSTATIC HYPERPLASIA - LONG-TERM EFFICACY AND SAFETY IN HYPERTENSIVE AND NORMOTENSIVE PATIENTS

Purpose: We evaluated the sustained efficacy and safety of doxazosin f or long-term treatment (up to 48 months) of normotensive and hypertens ive patients with benign prostatic hyperplasia (BPH). Materials and Me thods: A total of 272 normotensive and 178 mildly to moderately hypert ensive 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 pa rticipation 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 hyperte nsive 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 mi. per second, respectively). As assessed by the patient, total, obstructive and irr itative BPH symptoms also improved significantly with doxazosin treatm ent. In the 28 patients who completed 45 to 48 months of treatment imp rovement in symptom bothersomeness (13.2%) was similar to that of the overall group at the end point (14.8%). Sustained blood pressure decre ases (approximately 8/11 mm. Hg systolic/diastolic blood pressure) wit h doxazosin were statistically and clinically significant in hypertens ive patients. Blood pressure decreases in normotensive patients were n ot 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 wa s well tolerated with almost 90% of adverse experiences considered mil d or moderate in severity. The most common adverse events were dizzine ss, headache and fatigue in normotensive and hypertensive patients. Co nclusions: In this study long-term doxazosin treatment was significant ly effective and well tolerated for treating BPH in normotensive and h ypertensive patients.