TY - JOUR
T1 - First dose efficacy of alfuzosin once daily in men with symptomatic benign prostatic hyperplasia
AU - Marks, Leonard S.
AU - Roehrborn, Claus
AU - Gittelman, Marc
AU - Kim, Daniel
AU - Forrest, John
AU - Jacobs, Sharon
N1 - Funding Information:
The ALFIRST Trial was sponsored by Sanofi-Synthelabo. The members of the ALFIRST Study Group are given in the Appendix .
PY - 2003/11
Y1 - 2003/11
N2 - Objectives. To evaluate the onset of action of alfuzosin once daily (OD) as determined by uroflowmetry early after initial dosing. Alfuzosin OD is an extended-release formulation of a uroselective, alpha1- adrenoreceptor-blocking agent (alpha-blocker) used in the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Methods. This was a randomized, placebo-controlled, two-way Latin square crossover study. Forty-nine patients were selected for this study on the basis of their symptomatic improvement during previous treatment with alpha-blockers and significant decreases in urinary flow rate when that treatment was withdrawn. Results. Our analysis showed that significant increases in the maximal urinary flow rate (Qmax) in 34 assessable patients occurred as soon as 8 hours after the initial dose of medication and persisted for at least 4 days. The ΔQmax for alfuzosin 10 mg OD was 3.2 mL/s and for placebo it was 1.1 mL/s. The difference of means for the assessable population was 2.1 (95% confidence interval 0.8 to 3.4, P = 0.002). The overall incidence of adverse events was low. Only dizziness, experienced by 3 patients treated with alfuzosin compared with 1 patient treated with placebo, appeared to be related to the study drug. Conclusions. Together, our findings suggest that alfuzosin OD exhibits a urodynamically measurable effect on bladder outlet obstruction due to benign prostatic hyperplasia in men with lower urinary tract symptoms within hours of the first administration.
AB - Objectives. To evaluate the onset of action of alfuzosin once daily (OD) as determined by uroflowmetry early after initial dosing. Alfuzosin OD is an extended-release formulation of a uroselective, alpha1- adrenoreceptor-blocking agent (alpha-blocker) used in the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Methods. This was a randomized, placebo-controlled, two-way Latin square crossover study. Forty-nine patients were selected for this study on the basis of their symptomatic improvement during previous treatment with alpha-blockers and significant decreases in urinary flow rate when that treatment was withdrawn. Results. Our analysis showed that significant increases in the maximal urinary flow rate (Qmax) in 34 assessable patients occurred as soon as 8 hours after the initial dose of medication and persisted for at least 4 days. The ΔQmax for alfuzosin 10 mg OD was 3.2 mL/s and for placebo it was 1.1 mL/s. The difference of means for the assessable population was 2.1 (95% confidence interval 0.8 to 3.4, P = 0.002). The overall incidence of adverse events was low. Only dizziness, experienced by 3 patients treated with alfuzosin compared with 1 patient treated with placebo, appeared to be related to the study drug. Conclusions. Together, our findings suggest that alfuzosin OD exhibits a urodynamically measurable effect on bladder outlet obstruction due to benign prostatic hyperplasia in men with lower urinary tract symptoms within hours of the first administration.
UR - http://www.scopus.com/inward/record.url?scp=0242495777&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0242495777&partnerID=8YFLogxK
U2 - 10.1016/S0090-4295(03)00657-5
DO - 10.1016/S0090-4295(03)00657-5
M3 - Article
C2 - 14624914
AN - SCOPUS:0242495777
SN - 0090-4295
VL - 62
SP - 888
EP - 893
JO - Urology
JF - Urology
IS - 5
ER -