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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 : 000395 ( PascalFrancis/Corpus ); précédent : 000394; suivant : 000396

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 ; Roger R. Dmochowski ; Daniel J. Lama ; Rodney U. Anderson ; Peter K. Sand ; Kelly Molpus

Source :

RBID : Pascal:05-0375672

Descripteurs français

English descriptors

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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

pA  
A01 01  1    @0 0002-9378
A02 01      @0 AJOGAH
A03   1    @0 Am. j. obstet. gynecol.
A05       @2 192
A06       @2 6
A08 01  1  ENG  @1 Extended-release formulations of oxybutynin and tolterodine exhibit similar central nervous system tolerability profiles : A subanalysis of data from the OPERA trial. Discussion
A11 01  1    @1 CHU (Franklin M.)
A11 02  1    @1 DMOCHOWSKI (Roger R.)
A11 03  1    @1 LAMA (Daniel J.)
A11 04  1    @1 ANDERSON (Rodney U.)
A11 05  1    @1 SAND (Peter K.)
A11 06  1    @1 MOLPUS (Kelly)
A14 01      @1 San Bernardino Urological Associates @2 San Bernardino, CA @3 USA @Z 1 aut. @Z 3 aut.
A14 02      @1 Vanderbilt University Medical School @2 Nashville, TN @3 USA @Z 2 aut.
A14 03      @1 Stanford University School of Medicine @2 Stanford, CA @3 USA @Z 4 aut.
A14 04      @1 Northwestern University Medical School @2 Evanston, IL @3 USA @Z 5 aut.
A20       @1 1849-1855
A21       @1 2005
A23 01      @0 ENG
A43 01      @1 INIST @2 3053 @5 354000131538700110
A44       @0 0000 @1 © 2005 INIST-CNRS. All rights reserved.
A45       @0 27 ref.
A47 01  1    @0 05-0375672
A60       @1 P @2 C @3 AR @3 CT
A61       @0 A
A64 01  1    @0 American journal of obstetrics and gynecology
A66 01      @0 USA
C01 01    ENG  @0 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.
C02 01  X    @0 002B20
C03 01  X  FRE  @0 Oxybutynine @2 NK @2 FR @5 01
C03 01  X  ENG  @0 Oxybutynin @2 NK @2 FR @5 01
C03 01  X  SPA  @0 Oxibutinina @2 NK @2 FR @5 01
C03 02  X  FRE  @0 Libération @5 02
C03 02  X  ENG  @0 Release @5 02
C03 02  X  SPA  @0 Liberación @5 02
C03 03  X  FRE  @0 Formulation @5 03
C03 03  X  ENG  @0 Formulation @5 03
C03 03  X  SPA  @0 Formulación @5 03
C03 04  X  FRE  @0 Toltérodine @2 NK @2 FR @5 04
C03 04  X  ENG  @0 Tolterodine @2 NK @2 FR @5 04
C03 04  X  SPA  @0 Tolterodina @2 NK @2 FR @5 04
C03 05  X  FRE  @0 Système nerveux central @5 05
C03 05  X  ENG  @0 Central nervous system @5 05
C03 05  X  SPA  @0 Sistema nervioso central @5 05
C03 06  X  FRE  @0 Essai clinique @5 06
C03 06  X  ENG  @0 Clinical trial @5 06
C03 06  X  SPA  @0 Ensayo clínico @5 06
C03 07  X  FRE  @0 Discussion @5 08
C03 07  X  ENG  @0 Discussion @5 08
C03 07  X  SPA  @0 Discusión @5 08
C03 08  X  FRE  @0 Effet secondaire @5 09
C03 08  X  ENG  @0 Secondary effect @5 09
C03 08  X  SPA  @0 Efecto secundario @5 09
C03 09  X  FRE  @0 Gynécologie @5 11
C03 09  X  ENG  @0 Gynecology @5 11
C03 09  X  SPA  @0 Ginecología @5 11
C03 10  X  FRE  @0 Obstétrique @5 12
C03 10  X  ENG  @0 Obstetrics @5 12
C03 10  X  SPA  @0 Obstétrico @5 12
C07 01  X  FRE  @0 Antagoniste @5 37
C07 01  X  ENG  @0 Antagonist @5 37
C07 01  X  SPA  @0 Antagonista @5 37
C07 02  X  FRE  @0 Parasympatholytique @5 38
C07 02  X  ENG  @0 Parasympatholytic @5 38
C07 02  X  SPA  @0 Parasimpatolítico @5 38
C07 03  X  FRE  @0 Récepteur cholinergique @5 39
C07 03  X  ENG  @0 Cholinergic receptor @5 39
C07 03  X  SPA  @0 Receptor colinérgico @5 39
C07 04  X  FRE  @0 Récepteur muscarinique @5 40
C07 04  X  ENG  @0 Muscarinic receptor @5 40
C07 04  X  SPA  @0 Receptor muscarínico @5 40
N21       @1 262
N44 01      @1 OTO
N82       @1 OTO
pR  
A30 01  1  ENG  @1 Annual Meeting of the Central Association of Obstetricians and Gynecologists @2 71 @3 Washington, DC USA @4 2004-10-13

Format Inist (serveur)

NO : PASCAL 05-0375672 INIST
ET : Extended-release formulations of oxybutynin and tolterodine exhibit similar central nervous system tolerability profiles : A subanalysis of data from the OPERA trial. Discussion
AU : CHU (Franklin M.); DMOCHOWSKI (Roger R.); LAMA (Daniel J.); ANDERSON (Rodney U.); SAND (Peter K.); MOLPUS (Kelly)
AF : San Bernardino Urological Associates/San Bernardino, CA/Etats-Unis (1 aut., 3 aut.); Vanderbilt University Medical School/Nashville, TN/Etats-Unis (2 aut.); Stanford University School of Medicine/Stanford, CA/Etats-Unis (4 aut.); Northwestern University Medical School/Evanston, IL/Etats-Unis (5 aut.)
DT : Publication en série; Congrès; Article; Commentaire; Niveau analytique
SO : American journal of obstetrics and gynecology; ISSN 0002-9378; Coden AJOGAH; Etats-Unis; Da. 2005; Vol. 192; No. 6; Pp. 1849-1855; Bibl. 27 ref.
LA : Anglais
EA : 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.
CC : 002B20
FD : Oxybutynine; Libération; Formulation; Toltérodine; Système nerveux central; Essai clinique; Discussion; Effet secondaire; Gynécologie; Obstétrique
FG : Antagoniste; Parasympatholytique; Récepteur cholinergique; Récepteur muscarinique
ED : Oxybutynin; Release; Formulation; Tolterodine; Central nervous system; Clinical trial; Discussion; Secondary effect; Gynecology; Obstetrics
EG : Antagonist; Parasympatholytic; Cholinergic receptor; Muscarinic receptor
SD : Oxibutinina; Liberación; Formulación; Tolterodina; Sistema nervioso central; Ensayo clínico; Discusión; Efecto secundario; Ginecología; Obstétrico
LO : INIST-3053.354000131538700110
ID : 05-0375672

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Pascal:05-0375672

Le document en format XML

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<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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<s0>Formulación</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Toltérodine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Tolterodine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Tolterodina</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Système nerveux central</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Central nervous system</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Sistema nervioso central</s0>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Essai clinique</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Clinical trial</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Ensayo clínico</s0>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Discussion</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Discussion</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Discusión</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Effet secondaire</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Secondary effect</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Efecto secundario</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Gynécologie</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Gynecology</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Ginecología</s0>
<s5>11</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Obstétrique</s0>
<s5>12</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Obstetrics</s0>
<s5>12</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Obstétrico</s0>
<s5>12</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Antagoniste</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Antagonist</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Antagonista</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Parasympatholytique</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Parasympatholytic</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Parasimpatolítico</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Récepteur cholinergique</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Cholinergic receptor</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Receptor colinérgico</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Récepteur muscarinique</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Muscarinic receptor</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Receptor muscarínico</s0>
<s5>40</s5>
</fC07>
<fN21>
<s1>262</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
<pR>
<fA30 i1="01" i2="1" l="ENG">
<s1>Annual Meeting of the Central Association of Obstetricians and Gynecologists</s1>
<s2>71</s2>
<s3>Washington, DC USA</s3>
<s4>2004-10-13</s4>
</fA30>
</pR>
</standard>
<server>
<NO>PASCAL 05-0375672 INIST</NO>
<ET>Extended-release formulations of oxybutynin and tolterodine exhibit similar central nervous system tolerability profiles : A subanalysis of data from the OPERA trial. Discussion</ET>
<AU>CHU (Franklin M.); DMOCHOWSKI (Roger R.); LAMA (Daniel J.); ANDERSON (Rodney U.); SAND (Peter K.); MOLPUS (Kelly)</AU>
<AF>San Bernardino Urological Associates/San Bernardino, CA/Etats-Unis (1 aut., 3 aut.); Vanderbilt University Medical School/Nashville, TN/Etats-Unis (2 aut.); Stanford University School of Medicine/Stanford, CA/Etats-Unis (4 aut.); Northwestern University Medical School/Evanston, IL/Etats-Unis (5 aut.)</AF>
<DT>Publication en série; Congrès; Article; Commentaire; Niveau analytique</DT>
<SO>American journal of obstetrics and gynecology; ISSN 0002-9378; Coden AJOGAH; Etats-Unis; Da. 2005; Vol. 192; No. 6; Pp. 1849-1855; Bibl. 27 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002B20</CC>
<FD>Oxybutynine; Libération; Formulation; Toltérodine; Système nerveux central; Essai clinique; Discussion; Effet secondaire; Gynécologie; Obstétrique</FD>
<FG>Antagoniste; Parasympatholytique; Récepteur cholinergique; Récepteur muscarinique</FG>
<ED>Oxybutynin; Release; Formulation; Tolterodine; Central nervous system; Clinical trial; Discussion; Secondary effect; Gynecology; Obstetrics</ED>
<EG>Antagonist; Parasympatholytic; Cholinergic receptor; Muscarinic receptor</EG>
<SD>Oxibutinina; Liberación; Formulación; Tolterodina; Sistema nervioso central; Ensayo clínico; Discusión; Efecto secundario; Ginecología; Obstétrico</SD>
<LO>INIST-3053.354000131538700110</LO>
<ID>05-0375672</ID>
</server>
</inist>
</record>

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