Results
The primary efficacy evaluations in this study were changes from baseline in total AUA Symptom Score and Qmax. Total AUA Symptom Score (0-30) mean change from baseline (17.4) over 6 years ranged from -8.1 to -10.9. For each year, this was a statistically significant (P<0.05) improvement from baseline (defined as ≥25% decrease in symptom score). For the 159 patients who had a potential 6 years of tamsulosin experience, the mean improvements from baseline are shown below.1
Symptom improvement was significant and lasted for the duration of the study. The number of patients who responded clinically was consistent during the first five years (71.6%-74.5%) and was 80.7% in the sixth year.1,2
The mean improvement in Qmax from baseline (10.0 mL/sec) ranged from +1.01 mL/sec to +2.29 mL/sec. For each year, this was a significant improvement from baseline. The percentage of patients who responded to treatment (defined as ≥30% change from baseline) was greatest during the first year and was maintained throughout the duration of the study.1
See the safety data from study 527.2
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.
