Tolerability of α-blockade with doxazosin as a therapeutic option for symptomatic benign prostatic hyperplasia in the elderly patient:: A pooled analysis of seven double-blind, placebo-controlled studies

Background. Benign prostatic hyperplasia (BPH) is a common disorder in males, and its incidence increases with age. Safety results from trials with doxazosin therapy in elderly patients were collated and described. Methods. Safety data were collated from seven completed multicenter, double-blind, placebo-controlled studies of doxazosin in the treatment of BPH in older patients and analyzed according to age group (<65 and greater than or equal to 65 years) and blood pressure status. Results. Data for 341 patients aged greater than or equal to 65 years (217 normotensive, 124 hypertensive) and 322 patients aged <65 years (207 normotensive, 115 hypertensive) were available. In normotensive subjects a statistically nonsignificant smaller percentage of elderly patients reported adverse events than younger patients in both doxazosin (42% compared with 47%) and placebo (38% compared with 44%) groups. The most common adverse events were fatigue, headache, and dizziness whereas withdrawals due to adverse events were 6% (elderly) and 7% (younger) for doxazosin patients and 9% and 5% for placebo patients, respectively. In hypertensive patients 43% of elderly doxazosin patients reported adverse events compared with 30% of elderly placebo patients, the most common events in both groups being dizziness, headache, fatigue, and dyspnea. Incidence of withdrawal due to adverse events was 11% with doxazosin and 4% with placebo. Very few serious adverse events were reported throughout these trials in any group. Nonsignificant reductions in mean blood pressure were seen in all normotensive patients. Fewer elderly patients had a clinically significant reduction in blood pressure than younger patients (26% vs 30%, respectively). Conclusions. These studies show doxazosin to be equally well tolerated in young and old, normotensive and hypertensive patients with BPH.