Results
For the primary efficacy endpoint parameters, significant improvement in the total AUA Symptom Score compared with placebo was seen after one week of treatment with tamsulosin (0.4 mg/day); P<0.001. At the end of the trial, 70% of patients achieved ≥25% decrease in symptoms with tamsulosin compared with 51% with placebo.1
Significant improvement in Qmax was observed within 4 to 8 hours after a single dose of tamsulosin 0.4 mg (P=0.05) compared with placebo and was maintained throughout the 13 weeks of the trial. At the end of the trial, a significantly higher percentage of patients achieved ≥30% improvement in Qmax with tamsulosin than with placebo. The mean change in total AUA Symptom Score at endpoint between tamsulosin 0.4 mg (-8.3 ± 6.3 [n=246]) and 0.8 mg (-9.6 ± 6.2 [n=237]) was not statistically significant.1
Quality of life
In order to determine the impact of urinary symptoms on quality of life, the investigators administered the BPH Impact Index, a four-item questionnaire, at baseline and again at study termination. The mean changes in total quality-of-life score were significantly greater in the tamsulosin groups compared with those in the placebo group (-3.2 for tamsulosin 0.4 mg/day, -3.6 for tamsulosin 0.8 mg/day and -1.8 for placebo; P<0.001).1,3
The investigators concluded that tamsulosin significantly improved BPH Impact Index quality of life scores, and that these improvements correlated by subscore with the improvements seen in AUA Symptom Scores.3
See the safety data from US 92-03A
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.
2. FLOMAX Prescribing Information, Boehringer Ingelheim Pharmaceuticals, Inc.
3. Barry M, Lepor H, and the Tamsulosin Investigator Group. Filling and voiding subscores of the AUA Symptom Index in a trial of tamsulosin for benign prostatic hyperplasia (BPH). Presented at the Annual Meeting of the AUA in New Orleans, La, April 1997. Abstract 536.
