Oxytrol Highlights Prescribe OXYTROL — a first-line drug therapy with powerful efficacy
Power to reduce weekly incontinence episodes [1]
Placebo group achieved a 50% reduction in incontenence episodes [1]
All patients were instructed in nonpharmacologic treatment measures [2]
Only 22% of patients had received prior anticholinergic therapy at study entry [2]
Power to reduce daily incontinence episodes [1]
Placebo group achieved a 50% reduction in incontenence episodes [1]
All patients were instructed to continue their usual fluid intake and nonpharmacologic treatment measures [4]
100% of patients had received a beneficial response from prior anticholinergic therapy at time of study entry [1]
Power to treat their symptoms
OXYTROL is the only transdermal system that delivers the power
of oxybutynin to treat overactive bladder with symptoms of urge urinary
incontinence, urgency, frequency. [1]
Please see full prescribing information for OXYTROL
Oxytrol Highlight References: * Study 1 was a phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled trial of
OXYTROL (1.3, 2.6, and 3.9 mg/day). Median weekly baseline and end point values were 31 and 12,
respectively, for OXYTROL (n=120) and 30 and 15, respectively, for placebo (n=127).
† Throughout both studies, patients were instructed to continue nonpharmacologic treatment measures
(eg, pelvic floor exercise, timed voiding, or other behavioral techniques) consistent with standard
practices.
‡ Comparison significant if P<.05.
ll Median decrease of 15 incontinence episodes with placebo.
§ Study 2 was a phase 3, 12-week, multicenter, randomized, double-blind, placeboand active-controlled
trial of OXYTROL (3.9 mg/day). Median daily baseline and end point values were 4 and 1, respectively,
for OXYTROL (n=121) and 4 and 2, respectively, for placebo (n=117). All patients had a prior beneficial
response to pharmacologic treatment for overactive bladder.
¶ In Study 1, 15% of OXYTROL patients and 8.6% of placebo patients reported no incontinence episodes
at study end point.
[1] OXYTROL® Prescribing Information. February 2003.
[2] Dmochowski RR, Davila GW, Zinner NR, et al, for the Transdermal Oxybutynin Study Group. Efficacy and safety of transdermal oxybutynin in patients with urge and mixed urinary incontinence. J Urol. 2002;168:580-586.
[3] Data on file, Watson Pharma, Inc.
[4] Dmochowski RR, Sand PK, Zinner NR, et al. Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence. Urology. 2003;62:237-242.
[5] Appel RA, Chancellor MB, Zobrist RH, Thomas H, Sanders SW. Pharmacokinetics, metabolism, and saliva output during transdermal and extended-release oral oxybutynin administration in healthy subjects. Mayo Clin Proc. 2003;78:696-702.
[6] Zobrist RH, Schmid B, Feick A, Quan D, Sanders SW.Pharmacokinetics of the R- and S-enantiomers of oxybutynin and N-desethyloxybutynin following oral and transdermal administration of the racemate in healthy volunteers. Pharm Res. 2001;18:1029-1034.
[7] OXYTROL® Patient Prescribing Information.
