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Extended-release formulations of oxybutynin and tolterodine exhibit similar central nervous system tolerability profiles : A subanalysis of data from the OPERA trial. Discussion

Identifieur interne : 001B58 ( Main/Exploration ); précédent : 001B57; suivant : 001B59

Extended-release formulations of oxybutynin and tolterodine exhibit similar central nervous system tolerability profiles : A subanalysis of data from the OPERA trial. Discussion

Auteurs : Franklin M. Chu [États-Unis] ; Roger R. Dmochowski [États-Unis] ; Daniel J. Lama [États-Unis] ; Rodney U. Anderson [États-Unis] ; Peter K. Sand [États-Unis] ; Kelly Molpus

Source :

American journal of obstetrics and gynecology [ 0002-9378 ] ; 2005.

RBID : Pascal:05-0375672

Descripteurs français

Pascal (Inist)
- Oxybutynine, Libération, Formulation, Toltérodine, Système nerveux central, Essai clinique, Discussion, Effet secondaire, Gynécologie, Obstétrique.
Wicri :
- topic : Gynécologie.

English descriptors

KwdEn :
- Benzhydryl Compounds (administration & dosage), Benzhydryl Compounds (adverse effects), Central Nervous System (drug effects), Central nervous system, Clinical trial, Cresols (administration & dosage), Cresols (adverse effects), Delayed-Action Preparations, Discussion, Double-Blind Method, Female, Formulation, Gynecology, Humans, Mandelic Acids (administration & dosage), Mandelic Acids (adverse effects), Muscarinic Antagonists (administration & dosage), Muscarinic Antagonists (adverse effects), Obstetrics, Oxybutynin, Phenylpropanolamine (administration & dosage), Phenylpropanolamine (adverse effects), Randomized Controlled Trials as Topic, Release, Secondary effect, Tolterodine, Tolterodine Tartrate, Urinary Incontinence (drug therapy), Urinary Incontinence (physiopathology).
MESH :
- chemical , administration & dosage : Benzhydryl Compounds, Cresols, Mandelic Acids, Muscarinic Antagonists, Phenylpropanolamine.
- chemical , adverse effects : Benzhydryl Compounds, Cresols, Mandelic Acids, Muscarinic Antagonists, Phenylpropanolamine.
- drug effects : Central Nervous System.
- drug therapy : Urinary Incontinence.
- physiopathology : Urinary Incontinence.
- chemical : Delayed-Action Preparations, Double-Blind Method, Female, Humans, Randomized Controlled Trials as Topic, Tolterodine Tartrate.

Abstract

Objective: This study was undertaken to compare the central nervous system (CNS) tolerability profiles of the extended-release formulations of oxybutynin chloride and tolterodine tartrate in the treatment of women with overactive bladder (OAB), as observed in the OPERA (Overactive bladder: Performance of Extended Release Agents) trial. Study design: The OPERA trial was a randomized, double-blind, active-control comparison of the efficacy and safety of extended-release oxybutynin (10 mg/d) and extended-release tolterodine (4 mg/d) given to 790 women with OAB for 12 weeks. The incidence of reported CNS events was compared between the treatment groups by using the Fisher exact test. Results: The incidence of CNS adverse events was 9% and 8% for the oxybutynin and tolterodine treatment groups, respectively. The difference between groups was not statistically significant. All reported CNS adverse events were rated as mild or moderate in severity. There were no serious treatment-related adverse events in either group, and discontinuation because of a CNS adverse event was infrequent. Conclusion: The extended-release formulations of oxybutynin and tolterodine were observed to be associated with a similar low incidence of CNS adverse events, which were mostly mild or moderate in severity.

Affiliations:

Le document en format XML

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<term>Central nervous system</term>
<term>Clinical trial</term>
<term>Cresols (administration & dosage)</term>
<term>Cresols (adverse effects)</term>
<term>Delayed-Action Preparations</term>
<term>Discussion</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Formulation</term>
<term>Gynecology</term>
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<term>Mandelic Acids (adverse effects)</term>
<term>Muscarinic Antagonists (administration & dosage)</term>
<term>Muscarinic Antagonists (adverse effects)</term>
<term>Obstetrics</term>
<term>Oxybutynin</term>
<term>Phenylpropanolamine (administration & dosage)</term>
<term>Phenylpropanolamine (adverse effects)</term>
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<term>Urinary Incontinence (physiopathology)</term>
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<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Benzhydryl Compounds</term>
<term>Cresols</term>
<term>Mandelic Acids</term>
<term>Muscarinic Antagonists</term>
<term>Phenylpropanolamine</term>
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<term>Cresols</term>
<term>Mandelic Acids</term>
<term>Muscarinic Antagonists</term>
<term>Phenylpropanolamine</term>
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<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Central Nervous System</term>
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<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Urinary Incontinence</term>
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<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Randomized Controlled Trials as Topic</term>
<term>Tolterodine Tartrate</term>
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<term>Libération</term>
<term>Formulation</term>
<term>Toltérodine</term>
<term>Système nerveux central</term>
<term>Essai clinique</term>
<term>Discussion</term>
<term>Effet secondaire</term>
<term>Gynécologie</term>
<term>Obstétrique</term>
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<front><div type="abstract" xml:lang="en">Objective: This study was undertaken to compare the central nervous system (CNS) tolerability profiles of the extended-release formulations of oxybutynin chloride and tolterodine tartrate in the treatment of women with overactive bladder (OAB), as observed in the OPERA (Overactive bladder: Performance of Extended Release Agents) trial. Study design: The OPERA trial was a randomized, double-blind, active-control comparison of the efficacy and safety of extended-release oxybutynin (10 mg/d) and extended-release tolterodine (4 mg/d) given to 790 women with OAB for 12 weeks. The incidence of reported CNS events was compared between the treatment groups by using the Fisher exact test. Results: The incidence of CNS adverse events was 9% and 8% for the oxybutynin and tolterodine treatment groups, respectively. The difference between groups was not statistically significant. All reported CNS adverse events were rated as mild or moderate in severity. There were no serious treatment-related adverse events in either group, and discontinuation because of a CNS adverse event was infrequent. Conclusion: The extended-release formulations of oxybutynin and tolterodine were observed to be associated with a similar low incidence of CNS adverse events, which were mostly mild or moderate in severity.</div>
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<country name="États-Unis"><region name="Californie"><name sortKey="Chu, Franklin M" sort="Chu, Franklin M" uniqKey="Chu F" first="Franklin M." last="Chu">Franklin M. Chu</name>
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<name sortKey="Anderson, Rodney U" sort="Anderson, Rodney U" uniqKey="Anderson R" first="Rodney U." last="Anderson">Rodney U. Anderson</name>
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<name sortKey="Lama, Daniel J" sort="Lama, Daniel J" uniqKey="Lama D" first="Daniel J." last="Lama">Daniel J. Lama</name>
<name sortKey="Sand, Peter K" sort="Sand, Peter K" uniqKey="Sand P" first="Peter K." last="Sand">Peter K. Sand</name>
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Extended-release formulations of oxybutynin and tolterodine exhibit similar central nervous system tolerability profiles : A subanalysis of data from the OPERA trial. Discussion

Extended-release formulations of oxybutynin and tolterodine exhibit similar central nervous system tolerability profiles : A subanalysis of data from the OPERA trial. Discussion

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Descripteurs français

English descriptors

Abstract

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