DOXAZOSIN IN PHYSIOLOGICALLY AND PHARMACOLOGICALLY NORMOTENSIVE MEN WITH BENIGN PROSTATIC HYPERPLASIA

Objectives. To compare the effects of doxazosin on blood pressure when used for the treatment of benign prostatic hyperplasia (BPH) in men w ho are either physiologically or pharmacologically normotensive. Metho ds, Sixty-three men with BPH were enrolled in two open-label, parallel , randomized studies. Thirty-one were physiologically normotensive and 32 had hypertension controlled by antihypertensive therapy (pharmacol ogically normotensive). Of these, 17 were taking calcium channel block ers; 6, angiotensin-converting enzyme inhibitors; and 9, beta blockers . After a 3-week titration period, patients from one study received do xazosin (4 mg/day) for 3 months, given as a single dose in either the morning or evening, and in the second study patients were randomized t o receive either 4 mg or 8 mg daily, either in the morning or evening. Effects on blood pressure, maximum uroflow, and the Boyarsky symptom score were measured, Results, Doxazosin produced statistically signifi cant but clinically unimportant reductions in blood pressure in both p hysiologically and pharmacologically normotensive groups. Statisticall y and clinically significant improvements in BPH symptoms and maximal perfusion occurred in both groups within 1 month, and further improvem ents were observed after 3 months. These effects were evident whether doxazosin was administered in the morning or evening. Doxazosin was we ll tolerated, the only adverse events being dizziness in 5 patients an d fatigue in 4. By protocol, all patients reporting adverse events wer e required to be discontinued from the study. Adverse events did not d iffer between the groups. There was some indication that patients expe riencing adverse events also experienced greater reductions in blood p ressure. Conclusions, Doxazosin may be introduced for the treatment of BPH in hypertensive men whose blood pressure is already controlled by another antihypertensive agent, without a further clinical reduction in blood pressure. It is effective and well tolerated as a once-daily dose given in the morning or evening.