Abstract | OBJECTIVE: To compare the pharmacokinetics and adverse effect dynamics of 2 modified-release oxybutynin treatments. SUBJECTS AND METHODS: Between October 15 and November 6, 2001, 13 healthy subjects (7 men and 6 women) participated in a randomized, 2-way crossover study of transdermal ( Oxytrol, 3.9 mg/d) and extended-release oral ( Ditropan XL, 10 mg) oxybutynin. Multiple blood and saliva samples were collected. Pharmacokinetic parameters and total salivary output were assessed. Statistical analyses included 95% confidence intervals, paired t test, analysis of variance, and linear regression. RESULTS: Steady-state plasma concentrations were achieved after the first transdermal application and after the second extended-release oral dose. Mean +/- SD 24-hour oxybutynin areas under the concentration-time curve were comparable during transdermal and oral extended-release treatments, 10.8 +/- 24 vs 9.2 +/- 33 ng x h(-1) x mL(-1), respectively. However, the ratio of area under the curve ( N-desethyloxybutynin/ oxybutynin) after transdermal administration (1.2 +/- 03) was significantly lower (P < .001) than after extended-release oral administration (4.1 +/- 0.9). Mean plasma concentrations were less variable during transdermal compared with extended-release oral administration. Mean +/- SD saliva output was greater during transdermal than extended-release oral treatment (15.7 +/- 93 vs 12.2 +/- 6.8 g, respectively; P = .02). Lower N-desethyloxybutynin during transdermal application was associated with greater saliva output (r = -059, P = .04). No clinically important treatment-related adverse effects were observed. CONCLUSIONS:
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Authors | Rodney A Appell, Michael B Chancellor, R Howard Zobrist, Heather Thomas, Steven W Sanders |
Journal | Mayo Clinic proceedings
(Mayo Clin Proc)
Vol. 78
Issue 6
Pg. 696-702
(Jun 2003)
ISSN: 0025-6196 [Print] England |
PMID | 12934778
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Delayed-Action Preparations
- Mandelic Acids
- Muscarinic Antagonists
- desethyloxybutynin
- oxybutynin
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Topics |
- Administration, Cutaneous
- Administration, Oral
- Adult
- Analysis of Variance
- Cross-Over Studies
- Delayed-Action Preparations
- Female
- Humans
- Linear Models
- Male
- Mandelic Acids
(administration & dosage, blood, pharmacokinetics)
- Middle Aged
- Muscarinic Antagonists
(administration & dosage, blood, pharmacokinetics)
- Reference Values
- Saliva
(drug effects, metabolism)
- Salivation
(drug effects)
- Time Factors
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