Doxazosin in the treatment of benign prostatic hyperplasia. A review of the safety profile in older patients

Abstract

The objective of this paper is to review the safety of doxazosin in older patients (≥65 y) with benign prostatic hyperplasia (BPH) as reported in seven international clinical trials. Data from seven double-blind, placebo-controlled, phase III trials, in both normotensive and hypertensive patients with BPH were collated and analysed. Data on doxazosin were available for 341 men 65 y and over. Even though older patients can be at particular risk of adverse drug reactions, there was no apparent evidence of poor tolerability with doxazosin in older patients with BPH. The percentages of younger normotensive BPH patients (<65 y) experiencing at least one adverse event were 47 and 44% for doxazosin and placebo groups, respectively; for older normotensive BPH patients (≥65 y) the corresponding values were 42 and 38%. For the younger hypertensive BPH patients the incidence rates for adverse events were 55% (doxazosin) and 42% (placebo) and for older hypertensive BPH patients 43 and 30%, respectively. The most commonly reported adverse events for all groups were dizziness, headache and fatigue and few serious adverse effects were reported throughout these trials. It can be concluded that doxazosin is well tolerated in young and old, normotensive and hypertensive patients with BPH.