Objective
The first multicenter trial discussed previously (US 92-03A) was extended to 53 weeks to evaluate the long-term efficacy and safety of tamsulosin.
Design
A total of 418 patients from the 13-week trial entered the long-term trial and received an additional 40 weeks of double-blind therapy. Three hundred and twenty-three patients completed one year. The key efficacy measures were improvement in Qmax and total AUA Symptom Score.1
Efficacy Results
Improvements in the total AUA Symptom Score were significantly greater in the two tamsulosin treatment groups than in the placebo group, and were maintained consistently throughout the 53 weeks. The percentage of responders (defined as a 25% decrease in total AUA Symptom Score) was significantly higher for the tamsulosin groups than for the placebo group.
A total of 81% of patients treated with tamsulosin 0.4 mg responded compared with 78% for tamsulosin 0.8 mg and 59% for placebo. The higher response rate seen in the tamsulosin 0.4-mg group compared with the 0.8-mg group in long-term therapy indicates that the lower dose is effective in most patients.1
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. Lepor H, for the Tamsulosin Investigator Group. Long-term evaluation of tamsulosin in benign prostatic hyperplasia: placebo-controlled, double-blind extension of phase III trial. Urology. 1998;51:901-906.
