Objective
A second double-blind, phase III, placebo-controlled, multicenter trial with a protocol identical to the one described previously was undertaken to study the safety and efficacy of tamsulosin for the treatment of patients with signs and symptoms of BPH.
Efficacy Results
Efficacy results in this trial were similar to those of the first trial. Tamsulosin 0.4 mg resulted in a significantly greater decrease in total AUA Symptom Score and increase in Qmax compared with placebo.1
The percentage of responders was higher for both primary efficacy parameters with tamsulosin than with placebo. Tamsulosin 0.8 mg also produced significantly greater relief from symptoms and improvement in urine flow than did placebo.1
Conclusions
This clinical trial demonstrated that FLOMAX administered at 0.4 mg/day and 0.8 mg/day resulted in a statistically significant reduction in total AUA Symptom Scores compared with placebo (P<0.05). The percentage and number of patients with reduction or improvement in total AUA scores that was ≥25% from baseline to endpoint was 55% (133/244) in the group receiving tamsulosin 0.4 mg/day, 56% (134/238) in the group receiving tamsulosin 0.8 mg/day, and 40% (95/235) in the group taking placebo.
Compared with placebo, both these reductions (with tamsulosin 0.4 mg/day and 0.8 mg/day) were statistically significant (P<0.05). However, there was no significant difference in clinical efficacy between tamsulosin 0.4 mg/day and 0.8 mg/day (P>0.225). These study results demonstrated that tamsulosin 0.4 mg/day is just as efficacious as the 0.8-mg/day dose in relieving symptoms of BPH and improving urine flow.1
See the safety data from US 93-01
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See data from Long-term Trials of 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, Tewari A, and members of the United States 93-01 Study Group. A second phase III multicenter placebo controlled study of 2 dosages of modified release tamsulosin in patients with symptoms of benign prostatic hyperplasia. J Urol. 1998;160:1701-1706.
2. FLOMAX Prescribing Information, Boehringer Ingelheim Pharmaceuticals, Inc.
