The severity of lower urinary tract symptoms in patients with BPH and the likelihood of having diabetes are significantly associated. Within the limitations of an open label, observational study tamsulosin appears to reduce lower urinary tract symptoms similarly in patients with BPH with or without diabetes.

No abstract

The severity of lower urinary tract symptoms in patients with BPH and the likelihood of having diabetes are significantly associated. Within the limitations of an open label, observational study tamsulosin appears to reduce lower urinary tract symptoms similarly in patients with BPH with or without diabetes.

Tamsulosin is well tolerated and has marginal effects on blood pressure in the majority of patients. 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.

Aims Tamsulosin is an a 1 -adrenoceptor antagonist for the treatment of symptomatic benign prostatic hyperplasia with a tolerability similar to that of placebo in short-term, placebo-controlled studies with limited patient numbers. The present study was designed to test the safety of tamsulosin treatment in a large cohort of men during a prolonged period of time, particularly with regard to comedications. Methods A multicentre, open-label phase IIIb study with 1784 patients receiving 0.4 mg o.d. tamsulosin for 6 months was performed according to good clinical practice guidelines. The analysis was performed on an intention-to-treat basis and powered to detect adverse events (AE) occurring in 0.15% of patients with 95% con®dence. Results During a total drug exposure time of 811 patient years, 386 AE were recorded in 253 patients (14.2%; 95% con®dence intervals [CI] 12.0±15.2%). Twenty-nine patients suffered 44 serious AE including ®ve fatal events (CI 0.12±0.73%) due to myocardial infarction (n=3) and to pneumonia and a car accident (one each), but all deaths were judged to be unlikely to be related to study medication. The frequency of AE in patients without any comedication (n=1095) was 13.0% (CI 11.3±14.9%).In a logistic regression analysis b-adrenoceptor blockers, converting enzyme inhibitors, antidiabetics and diuretics did not signi®cantly affect the odds ratio for having AE. However, concomitant a-adrenoceptor antagonists (a protocol violation) and treatment with verapamil (which also has a-adrenoceptor antagonist activity) signi®cantly enhanced the odds ratio for having AE to 3.87 (CI 1.52±9.85) and 3.17 (CI 1.52±6.58), respectively. Minor increases in the odds ratio, which did not reach statistical signi®cance, were also observed for Ca 2+ antagonists other than verapamil and for nitrates. Conclusions We conclude that tamsulosin has a good safety pro®le relative to AE rates in the placebo arms of previous studies on tamsulosin even in the presence of most potentially complicating comedications. No major unexpected severe AE were recorded during our 6 months study.