Comparison of a 10-mg controlled release oxybutynin tablet with a 5-mg oxybutynin tablet in urge incontinent patients.
Oxybutynin has long been used for the treatment of patients with detrusor overactivity and urinary urge incontinence. The short half-life of oxybutynin administered as a conventional tablet formulation or syrup requires 2-3 times daily dosage to be effective. A new controlled release (CR) tablet for once-daily administration has been developed. The efficacy and tolerability of this new controlled release tablet was compared to that of a 5-mg conventional oxybutynin tablet administered twice daily. Seventeen female incontinent patients were studied in a double-dummy crossover trial. Efficacy and tolerability were assessed by using a voiding diary, pad-weighing test, visual-analogue scale (VAS), and questionnaire. Adverse events were recorded spontaneously on a questionnaire by the patients themselves throughout the study. Serum concentrations of oxybutynin and its active metabolite N-desethyloxybutynin were studied after both a single dose and multiple dosage. There was no difference in efficacy between the two formulations. Depending on the parameters tested, the change from baseline values in a positive direction ranged from 15 to 53%. The incidence of adverse events was similar with both formulations. Oxybutynin or its metabolite showed no cumulation during the multiple dosage with a 10-mg CR tablet. The controlled release tablet formulation is as effective and as well-tolerated as the conventional one, but has the advantage of only once-a-day dosage, enhancing treatment compliance.
Nilsson
C G
CG
Department of Obstetrics and Gynecology, Helsinki University Central Hospital, Finland.
Lukkari
E
E
Haarala
M
M
Kivelä
A
A
Hakonen
T
T
Kiilholma
P
P
D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008333:Mandelic Acids / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D008875:Middle Aged; D009994:Osmolar Concentration; D013607:Tablets; D014549:Urinary Incontinence / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology
D003692:Delayed-Action Preparations; D008333:Mandelic Acids; D013607:Tablets; C032681:desethyloxybutynin; C005419:oxybutynin