TOLERABILITY OF ALPHA-BLOCKADE WITH DOXAZOSIN AS A THERAPEUTIC OPTIONFOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA IN THE ELDERLY PATIENT -A POOLED ANALYSIS OF 7 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 tria ls with doxazosin therapy in elderly patients were collated and descri bed. Methods. Safety data were collated from seven completed multicent er, double-blind, placebo-controlled studies of doxazosin in the treat ment of BPH in older patients and analyzed according to age group (<65 and greater than or equal to 65 years) and blood pressure status. Res ults. Data for 341 patients aged greater than or equal to 65 years (21 7 normotensive, 124 hypertensive) and 322 patients aged <65 years (207 normotensive, 115 hypertensive) were available. In normotensive subje cts a statistically nonsignificant smaller percentage of elderly patie nts reported adverse events than younger patients in both doxazosin (4 2% compared with 47%) and placebo (38% compared with 44%) groups. The most common adverse events were fatigue, headache, and dizziness where as withdrawals due to adverse events were 6% (elderly) and 7% (younger ) for doxazosin patients and 9% and 5% for placebo patients, respectiv ely. In hypertensive patients 43% of elderly doxazosin patients report ed adverse events compared with 30% of elderly placebo patients, the m ost common events in both groups being dizziness, headache, fatigue, a nd dyspnea. Incidence of withdrawal due to adverse events was 11% with doxazosin and 4% with placebo. Very few serious adverse events were r eported throughout these trials in any group. Nonsignificant reduction s in mean blood pressure were seen in all normotensive patients. Fewer elderly patients had a clinically significant reduction in blood pres sure than younger patients (26% vs 30%, respectively). Conclusions. Th ese studies show doxazosin to be equally well tolerated in young and o ld, normotensive and hypertensive patients with BPH.