Tamsulosin: real life clinical experience in 19,365 patients.

OBJECTIVE

To compare the efficacy, global tolerability and blood pressure effects of tamsulosin (0.4 mg once daily) in subgroups of patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO).

METHODS

Data from two open-label, observational studies (Study I: 9,507 patients treated for 4 weeks, Study II: 9,858 patients treated for 12 weeks) were analyzed to compare efficacy, global tolerability and effects on blood pressure in subgroups of patients.

RESULTS

The efficacy of tamsulosin was largely unaffected by age or previous phytotherapy; in patients with severe symptoms, the efficacy was at least as large as in those with mild or moderate symptoms. More than 90% of patients reported a good or very good tolerability; in a multivariate analysis, this was slightly reduced in patients with concomitant disease but not affected by antihypertensive co-medication or baseline blood pressure. In patients without co-morbidity or co-medication, the tamsulosin-induced blood pressure reductions were similar to those previously reported for placebo treatment; mean additional blood pressure reductions in patients with concomitant disease or medication was not more than 2 mm Hg. Patients who had previously been treated with beta-sitosterol, other plant extracts or finasteride reported tamsulosin to be more effective than their previous treatment. Patients who had previously received beta-sitosterol or other plant extracts rated the global tolerability of tamsulosin to be similar to that of their previous treatment, while those who had previously received finasteride or other alpha 1-adrenoceptor antagonists rated the global tolerability of tamsulosin to be significantly better than that of their previous treatment.

CONCLUSIONS

We conclude that tamsulosin is efficacious in all types of patients with LUTS suggestive of BPO. It is globally well tolerated and has marginal effects on blood pressure, including the vast majority of patients with cardiovascular comorbidity, diabetes or on antihypertensive comedication.