Objective
ALFOTAM is a Sanofi-Synthelabo Inc. trial; the data are available on the Food and Drug Administration Web site. A multicenter, multinational, randomized, placebo-controlled, double-blind, phase III trial, ALFOTAM assessed the efficacy and safety of two dosage levels of alfuzosin Geomatrix (10 mg OD* and 15 mg OD*) vs tamsulosin 0.4 mg and placebo in patients with symptomatic BPH.1
Design
A total of 625 patients were randomized to treatment. A 28-day, single-blind, placebo run-in period was followed by a 3-month, double-blind, double-dummy treatment period during which patients received either alfuzosin 10 mg OD,* tamsulosin 0.4 mg, alfuzosin 15 mg OD* or placebo once a day. Six visits were planned: a screening visit (D-28), an inclusion visit (D0), three intermediate visits (D14, D28 and D58) and an endpoint visit (D84).1
Inclusion/Exclusion Criteria
The study population consisted of men older than 50 years of age with symptomatic BPH diagnosed within three months prior to treatment randomization. Patients had a mean International Prostate Symptom Score (IPSS) ≥13, nocturia ≥2 voids per night, a Qmax of 5 to 12 cc/sec with a voided volume of at least 150 cc, a residual urine volume <350 cc, and at least three months of voiding disturbances. Exclusion criteria included1:
- "bad" compliance during the screening period
- urologic disease other than BPH
- previous prostate surgery
- other invasive procedures for the treatment of BPH
- patients previously unimproved with α-blocker therapy
- those diagnosed with a lower urinary tract infection or a medical condition that would interfere with the efficacy or safety assessment
- patients with a history of orthostatic hypotension or syncope
- patients who received α-blockers within 1 month of study entry
- patients who received androgens, antiandrogens, 5 α-reductase inhibitors, or luteinizing hormone-releasing hormone analogues within 3 months of study entry
Efficacy variables
The primary efficacy endpoints for this study were the mean change from baseline to endpoint in IPSS and mean change from baseline to endpoint in Qmax. Secondary efficacy endpoints included:
- improvement in nocturia
- quality-of-life index
- Urolife scale
- sexual function questionnaire
- Clinical Global Impression
- mean urinary flow rate
- postvoid residual urine measured by transrectal ultrasonography.1
*OD = once daily.
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.
