A novel approach to the treatment of benign prostatic hyperplasia

Katalin Horváth, György Walter, Attila Varga, Imre Romics

Research output: Contribution to journalArticle

5 Citations (Scopus)


OBJECTIVE: To assess the clinical efficacy and safety of the combined α1- and postsynaptic α2-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 (Qmax), 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. Qmax 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 α1-blockers were reported. CONCLUSION: The combined α1- and postsynaptically selective α2-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.

Original languageEnglish
Pages (from-to)1252-1255
Number of pages4
JournalBJU International
Issue number6
Publication statusPublished - Jun 1 2006


  • Benign prostatic hyperplasia
  • Medical therapy
  • Outcome
  • α-blockers

ASJC Scopus subject areas

  • Urology

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