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® (tamsulosin HCl) capsules are indicated to treat the signs and symptoms of benign prostatic hyperplasia (BPH). FLOMAX is not indicated to treat hypertension.
FLOMAX is contraindicated in patients who are hypersensitive to tamsulosin HCl or any of its components.
As with other alpha-adrenergic blocking agents, there is a potential risk of syncope. When beginning treatment, or increasing the dose of FLOMAX, patients should be cautioned to avoid driving or performing hazardous tasks where injury could result should syncope occur.
FLOMAX capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g.,ketoconazole).
Rarely (probably less than 1 in 50,000 patients) FLOMAX, like other alpha-1 antagonists, has been associated with priapism. Because this condition can lead to permanent impotence if not properly treated, patients must be advised about the seriousness of the condition.
Carcinoma of the prostate and BPH cause many of the same symptoms. Patients should be evaluated prior to the start of FLOMAX capsules therapy to rule out the presence of carcinoma of the prostate.
Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha-1 blockers, including FLOMAX capsules. Patients should be advised that if they are considering cataract surgery, to tell their ophthalmologist that they have taken FLOMAX capsules.
In patients with sulfa allergy, allergic reaction to FLOMAX capsules has been rarely reported. If a patient reports a serious or life-threatening sulfa allergy, caution is warranted.
FLOMAX capsules should NOT be used in combination with other alpha-adrenergic blocking agents. Caution is advised when alpha-adrenergic blocking agents, including FLOMAX, are co-administered with PDE 5 inhibitors, as this can potentially cause symptomatic hypotension.
FLOMAX capsules (particularly at a dose higher than 0.4 mg) should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin), strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, or in patients known to be CYP2D6 poor metabolizers.
Caution should be exercised with concomitant administration of warfarin and FLOMAX and should be used with caution in combination with cimetidine, particularly at doses higher than 0.4 mg.
The most common side effects are dizziness, abnormal ejaculation, and rhinitis.
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.
