Tamsulosin 0.4 mg once daily: tolerability in older and younger patients with lower urinary tract symptoms suggestive of benign prostatic obstruction (symptomatic BPH). The European Tamsulosin Study Group.
OBJECTIVE
To compare the safety and tolerability of tamsulosin 0.4 mg once daily in younger (< 65 years) and older (> or = 65 years) patients with lower urinary tract symptoms (LUTS) suggestive 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 with tamsulosin or placebo for 12 weeks.


RESULTS
The incidence of adverse events, drug-related adverse events, serious adverse events and discontinuations due to adverse events was similar in older and younger tamsulosin-treated patients and was not significantly different from placebo. Although abnormal ejaculation was slightly more common in younger than older men receiving tamsulosin, the difference was not statistically significant from the placebo groups in both age groups. The incidence of adverse events possibly associated with vasodilation in tamsulosin-treated younger and older patients was 8.4 and 4.2%, respectively; these were comparable with the values for placebo-treated patients: 7.5 and 6%, respectively. Baseline systolic blood pressure was higher in older than younger patients, but there were minimal changes in blood pressure or pulse rate in tamsulosin- or placebo-treated patients in either age group.


CONCLUSIONS
Tamsulosin is well tolerated and suitable for use in older and younger patients with LUTS suggestive of BPO (symptomatic BPH).
Chapple
C R
CR
Department of Urology, Royal Hallamshire Hospital, Sheffield, UK.
Baert
L
L
Thind
P
P
Höfner
K
K
Khoe
G S
GS
Spångberg
A
A
D000317:Adrenergic alpha-Antagonists / Q000008:administration & dosage / Q000009:adverse effects*; D000367:Age Factors; D000368:Aged; D000704:Analysis of Variance; D001794:Blood Pressure / Q000187:drug effects; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000473:pathology; D011674:Pulse; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects*; D000077409:Tamsulosin; D014570:Urologic Diseases / Q000188:drug therapy* / Q000473:pathology
D000317:Adrenergic alpha-Antagonists; D013449:Sulfonamides; D000077409:Tamsulosin