Effect of an ATP-sensitive potassium channel opener in subjects with overactive bladder: a randomized, double-blind, placebo-controlled study (ZD0947IL/0004).

Abstract

OBJECTIVES:

Improvements over existing treatment standards in overactive bladder (OAB) may only be possible through the development of drugs acting via non-cholinergic pathways. This is the first clinical study to be reported in full for the use of a potassium channel opener in OAB.

METHODS:

This randomized, double-blind, placebo-controlled phase II study evaluated the efficacy and safety of ZD0947 (25mg/day for 12 weeks) in patients with OAB. The primary endpoint was mean volume voided per micturition per 24 hours. Key secondary endpoints were changes from baseline in mean numbers of micturition episodes (total, voluntary, and incontinent) per 24 hours.

RESULTS:

ZD0947 was not superior to placebo for the primary or secondary efficacy variables. The placebo-adjusted magnitude of effect for ZD0947 (approx. 4 mL) was less than the historic data for cholinergic antagonists (approx. 20 mL). Treatment was generally safe and well tolerated.

CONCLUSIONS:

The data for ZD0947 are disappointing. More studies are needed to advance the identification of novel, non-cholinergic therapies for OAB.

• Authors: Christopher R Chapple, Albena Patroneva, Shane R Raines
• Journal: European urology (Eur Urol) Vol. 49 Issue 5 Pg. 879-86 (May 2006) ISSN: 0302-2838 [Print] Switzerland
• PMID: 16517051 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dihydropyridines
• KATP Channels
• Potassium Channels, Inwardly Rectifying
• ZD0947
• uK-ATP-1 potassium channel

Topics

• Adolescent
• Adult
• Aged
• Dihydropyridines (therapeutic use)
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• KATP Channels
• Male
• Middle Aged
• Potassium Channels, Inwardly Rectifying (drug effects, metabolism)
• Quality of Life
• Retrospective Studies
• Treatment Outcome
• Urinary Incontinence (drug therapy, physiopathology)
• Urodynamics (drug effects, physiology)