Objective
A large-scale, multicenter, double-blind study (US 92-03A) was designed to examine the efficacy of tamsulosin in improving maximum urine flow rate (Qmax) and in relieving the symptoms seen with BPH, as well as the side effects of treatment.1
Design
Patients were evaluated for study eligibility during a four-week placebo lead-in period, during which compliance to the study protocol was established, as well as placebo response. A total of 756 patients were then randomized to receive either tamsulosin (0.4 mg/day and 0.8 mg/day) or placebo for 13 weeks. Primary efficacy data were based upon the intent-to-treat (ITT) population. All but one patient met intent-to-treat criteria, and 755 patients were included in the analysis.1
Inclusion/Exclusion Criteria
Patients had to be at least 45 years old to be admitted to the trial. Exclusion criteria included:
- allergy to α or β-blockers
- neurologic or cardiovascular disease
- diastolic blood pressure <65 mm Hg
- prior surgical procedures involving the urinary tract
Findings during the placebo evaluation period that excluded patient participation included poor compliance with the study medication, evidence of urinary infection or renal dysfunction, postural symptoms and evidence of prostate cancer. Patients were required to have a limited Qmax-between 4 and 15 mL/sec-and significant symptoms of BPH as measured by a total AUA Symptom Score ≥13.1
Efficacy Measures
The efficacy of tamsulosin was measured primarily as an improvement in the AUA Symptom Score and an improvement in Qmax. In addition, the percentage of patients responding to treatment (≥25% decrease in symptoms) was also evaluated, and quality of life was also assessed.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. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Urology. 1998;51:892-900.
