DOXAZOSIN IN THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA - A REVIEWOF THE SAFETY PROFILE IN OLDER PATIENTS

The objective of this paper is to review the safety of doxazosin in ol der patients (greater than or equal to 65 y) with benign prostatic hyp erplasia (BPH) as reported in seven international clinical trials. Dat a from seven double-blind, placebo-controlled, phase III trials, in bo th normotensive and hypertensive patients with BPH were collated and a nalysed. Data on doxazosin were available for 341 men 65y and over. Ev en though older patients can be at particular risk of adverse drug rea ctions, there was no apparent evidence of poor tolerability with doxaz osin in older patients with BPH. The percentages of younger normotensi ve BPH patients (< 65 y) experiencing at least one adverse event were 47 and 44% for doxazosin and placebo groups, respectively; for older n ormotensive BPH patients ( greater than or equal to 65 y) the correspo nding values were 42 and 38%. For the younger hypertensive BPH patient s the incidence rates for adverse events were 55% (doxazosin) and 42% (placebo) and for older hypertensive BPH patients 43 and 30%, respecti vely. The most commonly reported adverse events for all groups were di zziness, headache and fatigue and few serious adverse effects were rep orted throughout these trials. It can be concluded that doxazosin is w ell tolerated in young and old, normotensive and hypertensive patients with BPH.