PTU - Polskie Towarzystwo Urologiczne
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Article published in Urologia Polska 1999/52/2.


Martin C. Michel, Ludwig Mehlburger, Hans-Uirich Bressel, Helmut Schumacher, Rafael F. Schaffers, Mark Goepel
From the Departments of Medicine and Urology, University of Essen,
Boehringer Ingelheim, Ingelheim and Yamanouchi Pharma, Heidelberg


prostate BPH urinary tract concomitant disease


Purpose. We compare the tolerability and blood pressure effects of 0.4 mg. tamsulosin
once daily in patients with lower urinary symptoms suggestive of benign prostatic obstruction
with or without concomitant disease and/or antihypertensive medication.
Materials and methods: Data from 2 open label, observational studies (study 1,9507 patients
treated for 4 weeks and study 2, 9858 patients treated for 12 weeks) were analysed for
global tolerability and effects on blood pressure stratifying for co-morbidity (none, diabetes,
hypertension, other cardiovascular disease) and co-medication (diuretics, beta-blockers,
calcium channel blockers, angiotensin converting enzyme inhibitors).
Results. Overall 90 and 95% of patients in studies 1 and 2, respectively, reported good or
very good tolerability. While global tolerability was slightly reduced in patients with
concomitant disease or some forms of medication (p <0.05), it was rated as good or very
good by more than 90 and 95% of patients even in those groups. In control patients, that is
those with neither co-morbidity nor co-medication, the tamsulosin induced blood pressure
reductions were similar to those previously reported for placebo treatment but were
statistically significant (p <0.05). Mean additional blood pressure reductions in patients
with concomitant disease or medication were not more than 2 mm Hg.
Conclusions. Tamsulosin is well tolerated and has marginal effects on blood pressure in the
majority ofpatients. It largely maintains its good global tolerability and minimal blood
pressure effects in patients with cardiovascular co-morbidity or diabetes, or those on co-
medication with antihypertensive agents.


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