Objective
A randomized, open-label trial was conducted comparing the early onset of relief in the treatment of patients with signs and symptoms of BPH with either tamsulosin or terazosin. (Learn about the design of this trial.)
Results
In terms of patient tolerability and safety, tamsulosin treatment was associated with fewer blood pressure-related adverse events and fewer discontinuations due to treatment-emergent adverse events compared with terazosin treatment (4.3% vs 6.6%).1,2
This 11-week, randomized, open-label, multicenter, parallel-design study showed that tamsulosin was better tolerated than terazosin. Despite the fact that terazosin was titrated to treatment level over two weeks whereas FLOMAX was begun at the therapeutic dose, terazosin patients had more than twice the incidence of treatment-emergent fatigue, dizziness and somnolence.1,2
Discontinuation
Fewer patients discontinued treatment with tamsulosin than with terazosin due to treatment-emergent adverse events. Only 43 patients (4.3%, 43/1002) discontinued tamsulosin therapy due to adverse events.1,2
FLOMAX has not been associated with any clinically significant changes in urinalysis or routine biochemical and hematologic tests.3
See the efficacy results from the Tamsulosin vs Terazosin Trial (527.17)
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. Narayan P, O'Leary MP, Davidai G. Early efficacy of tamsulosin versus terazosin in the treatment of men with benign prostatic hyperplasia: a randomized, open-label trial. J Appl Res. 2005;5:237-245.
2. Data on File, Boehinger Ingelheim Pharmaceuticals, Inc.
3. FLOMAX Prescribing Information, Boehringer Ingelheim Pharmaceuticals, Inc.
