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The Safety and Efficacy of Transdermal Oxybutynin in the Management of Overactive Bladder
pattern, but presented lower levels than R- and S-OXY. After oral with placebo (dry mouth 7.3% and constipation 5.7% in TOL-LA, and 4.1
administration, R- and S-OXY reached peak in one hour and then and 3.3%, respectively, for OXY-TDS).
20
declined sharply; although R- and S-DEO followed the same pattern of
kinetics, their plasma levels were several-fold higher than those of R- and Recently, the safety and effectiveness of OXY-TDS were evaluated in the
S-OXY. The area under the time curve (AUC
0-t
) and the mean maximal Multicenter Assessment of Transdermal therapy in Overactive Bladder with
plasma concentration (C
max
) for R-OXY was lower compared with S-OXY oXybutynin (MATRIX). MATRIX was an open-label, prospective, randomised,
for both routes of administration. This pattern changes for R- and S-DEO multicentre cohort study of community-based adults with OAB. It included
in the oral administration group, where AUC
0-t
and C
max
for R-DEO were 2,888 individuals from 327 study centres; 369 were men. All subjects
higher compared with S-DEO. In the TDS group, the same parameters are received OXY-TDS for six months and completed validated questionnaires
always lower for R-DEO, and the authors concluded that the stereo- on OAB severity (patient perception of bladder condition [PPBC]), quality of
selective metabolism of OXY leads to higher plasma concentrations of
R-OXY during TDS administration. The high circulating concentrations
of R-DEO with oral dosing, on the other hand, may contribute to
the higher rate of anticholinergic effects observed with this route. The In contrast to oral forms, with
aforementioned observations strongly support TSD delivery as a valid
transdermal oxybutynin daily
alternative to oral administration.
18
administration is not required, which
The efficacy of OXY-TDS has been evaluated in several trials. Seventy-six
leads to better patient compliance.
patients with OAB, all responders to IR-OXY, were randomised into two
groups, each with 38 patients receiving either OXY-TDS or oral therapy.
Daily incontinence decreased in both treatment arms compared with the
wash-out group, but with no statistically significant difference between life (King’s Health Questionnaire [KHQ]) and depression (Beck Depression
the oral and TDS groups. However, the side effects rated as absent, mild, Inventory [BDI-II]), while safety was assessed by reports of adverse events. In
tolerable and intolerable were more evident in the oral group. Dry mouth male subjects (32.2% with pre-existing prostate problems and some of
was the most common adverse effect in the TDS group, and was present whom were under α
1
-blocker or 5-aldose reductase inhibitor [5ARI]
in a mild form in 27%, tolerable in 11% and intolerable in 0%; it was medication), PPBC decreased sharply after treatment and maintained that
absent in 62%. This compares with 26, 59, 9 and 6%, respectively, in the trend throughout the study period. KHQ was impaired in all 10 domains at
IR-OXY cohort. Fifty per cent of the patients in the oral group, but only baseline; however, after six months all 10 domains showed improvement, in
20% in the TDS group, presented constipation. The only side effect particular the incontinence impact domain (mean change of -8.9). The same
detected in the TDS subjects and the placebo arm but not in the IR-OXY improvement was observed in BDI-II questionnaires by study end (decrease
arm was erythema in the site where the patch was applied.
19
of 16.5%). In 13.8% of the subjects, reaction at the site of application was
the most common side effect, while dry mouth, nausea and constipation
In another placebo-controlled study, the efficacy and safety of OXY-TDS occurred in only 2.4, 1.4 and 1.1%, respectively.
were evaluated and compared with oral long-acting tolterodine (TOL-LA)
in 320 patients. Both groups presented the same reduction in daily OXY-TDS offers a therapeutic advantage over oral administration: hepatic
incontinence episodes, increased their average voided volume to the same metabolism is avoided, low levels of N-DEO are maintained and there is
extent and improved their Incontinence Impact Questionnaire score. continuous delivery of the native substance without fluctuations. In
However, anticholinergic adverse events occurred more frequently with contrast to oral forms, with OXY-TDS daily administration is not required,
TOL-LA, with a greater incidence of dry mouth and constipation compared which leads to better patient compliance. ■
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EUROPEAN UROLOGICAL REVIEW 69
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