Results
At study initiation, mean International Prostate Symptom Score (IPSS) baseline values were approximately equivalent for the placebo, alfuzosin 15-mg and tamsulosin 0.4-mg groups; values were slightly higher for the alfuzosin 10-mg group. Mean reduction in IPSS in the tamsulosin 0.4-mg group was superior to that in the placebo and the alfuzosin 15-mg groups and equal to that in the alfuzosin 10-mg group.1
At study initiation, Qmax scores were approximately equivalent for all groups. Mean study endpoint Qmax scores showed the greatest improvement in maximum flow rates with tamsulosin 0.4 mg. Alfuzosin 10 mg and 15 mg also improved Qmax vs placebo. Neither dose of alfuzosin compared with placebo reached statistical significance.1
See safety data from the ALFOTAM trial
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See pivotal 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. Center for Drug Evaluation and Research. Food and Drug Administration Web site. Available at: http://www.fda.gov/cder/foi/nda/2003/021287_uroxatral_toc.htm. Accessed July 12, 2006.
