Objective
A long-term (6 years) clinical trial of α-blockade therapy for patients with BPH was conducted. It evaluated the effectiveness and safety of FLOMAX in patients with lower urinary tract symptoms (LUTS) due to BPH.
Results
Safety results from the multicenter, open-label, extension long-term study reaffirm the solid safety profile that FLOMAX has exhibited in the pivotal trials. No additional safety issues arose during the 4-year extension with FLOMAX that had not been apparent during the previous studies. Only 4.8% (29/609) of the enrolled patients had a serious adverse event that was considered probably, possibly, or remotely related to tamsulosin treatment. A low number of patients (2%) developed subsequent prostate carcinomas during the 4-year extension study.
During the 4-year extension study, 11 patients (1.8%) reported symptoms of urinary retention. Only one patient developed acute urinary retention requiring discontinuation from the study. Overall, the discontinuation rates due to adverse events in this study were low over the course of 6 years and consistent with previous tamsulosin experience.1,2
Cardiovascular Effects
In the long-term study of tamsulosin, patients reported a low incidence of vasodilation-related symptoms.2 The table below shows that the mean orthostatic changes in systolic and diastolic blood pressure and pulse rate with tamsulosin treatment did not meaningfully change from baseline throughout the course of the clinical trial.
See the efficacy results from the Six-Year Efficacy and Safety Trial (527.2)
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See comparative safety data for FLOMAX |
Important Safety Information
FLOMAX is indicated to treat the signs and symptoms of benign prostatic hyperplasia (BPH). FLOMAX is not indicated to treat hypertension. As with other alpha-adrenergic blocking agents, there is a potential risk of syncope. Patients beginning treatment with FLOMAX should be cautioned to avoid driving or hazardous tasks for 12 hours after their first dose or increase in dose should syncope occur. The most common side effects are dizziness, abnormal ejaculation, and rhinitis.
Caution should be exercised with concomitant administration of warfarin and FLOMAX. In addition, FLOMAX should be used with caution in combination with cimetidine, particularly at doses higher than 0.4 mg. FLOMAX is contraindicated in patients known to be hypersensitive to tamsulosin HCl or any component of FLOMAX.
Before prescribing FLOMAX, please see the full Prescribing Information.
1. Narayan P, Evans CP, Moon T. Long-term safety and efficacy of tamsulosin for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia. J Urol. 2003;170:498-502.
2. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.
