Cr. Chapple et al., TAMSULOSIN 0.4 MG ONCE-DAILY - TOLERABILITY IN OLDER AND YOUNGER PATIENTS WITH LOWER URINARY-TRACT SYMPTOMS SUGGESTIVE OF BENIGN PROSTATIC OBSTRUCTION (SYMPTOMATIC BPH), European urology, 32(4), 1997, pp. 462-470
Objectives: To compare the safety and tolerability of tamsulosin 0.4 m
g once daily in younger (<65 years) and older (greater than or equal t
o 65 years) patients with lower urinary tract symptoms (LUTS) suggesti
ve of benign prostatic obstruction (BPO), Methods: In a retrospective
analysis of two European double-blind, randomized, placebo-controlled
trials, safety was assessed in 574 younger or older patients treated w
ith tamsulosin or placebo for 12 weeks. Results: The incidence of adve
rse events, drug-related adverse events, serious adverse events and di
scontinuations due to adverse events was similar in older and younger
tamsulosin-treated patients and was not significantly different from p
lacebo. Although abnormal ejaculation was slightly more common in youn
ger than older men receiving tamsulosin, the difference was not statis
tically significant from the placebo groups in both age groups. The in
cidence of adverse events possibly associated with vasodilation in tam
sulosin-treated younger and older patients was 8.4 and 4.2%, respectiv
ely; these were comparable with the values for placebo-treated patient
s: 7.5 and 6%, respectively, Baseline systolic blood pressure was high
er in older than younger patients, but there were minimal changes in b
lood pressure or pulse rate in tamsulosin- or placebo-treated patients
in either age group, Conclusions: Tamsulosin is well tolerated and su
itable for use in older and younger patients with LUTS suggestive of B
PO (symptomatic BPH).