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A novel approach to the treatment of benign prostatic hyperplasia
Author(s) -
HORVÁTH KATALIN,
WALTER GYÖRGY,
VARGA ATTILA,
ROMICS IMRE
Publication year - 2006
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2006.06181.x
Subject(s) - hyperplasia , urology , medicine
OBJECTIVE To assess the clinical efficacy and safety of the combined α 1 ‐ and postsynaptic α 2 ‐blocker GYKI‐16084 compared to placebo during a 28‐day active treatment of patients with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS After a 28‐day placebo run‐in phase, 7.5 and 15 mg GYKI‐16084 or placebo were administered twice daily for 28 days to patients with BPH in a randomized single‐blind Phase II study. Efficacy was primarily determined by changes in the American Urological Association (AUA) symptom scores and maximum urinary flow (Q max ), while safety was assessed by orthostatic changes and adverse‐event profile. A simplified International Index of Erectile Function questionnaire was used to assess effects on erectile function. RESULTS Data from 63 patients were evaluated; the decrease in the AUA score during the active phase was greater in the 15 mg group (−6.05, −32.7%) than in the placebo (−4.3, 22.7%) or 7.5 mg (−3.55, −19.5%) groups. Q max improved in both active treatment groups (+3.3 and +2.16 mL for the 7.5 and 15 mg groups, respectively) compared to placebo (+1.29 mL). None of the drug‐related adverse events associated with selective α 1 ‐blockers were reported. CONCLUSION The combined α 1 ‐ and postsynaptically selective α 2 ‐blocker GYKI‐16084 significantly improved the AUA symptom scores and increased Q max in patients with BPH, without inducing any adverse reaction, orthostatic changes or erectile dysfunction.