Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson's disease
Identifieur interne : 002A68 ( Main/Merge ); précédent : 002A67; suivant : 002A69Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson's disease
Auteurs : A. J. Lees [Royaume-Uni] ; V. Ratziu [France] ; E. Tolosa [Espagne] ; W. H. Oertel [Allemagne]Source :
- Journal of neurology, neurosurgery and psychiatry [ 0022-3050 ] ; 2007.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
Objective: The safety and tolerability of adjunctive tolcapone initiated simultaneously with levodopa was evaluated with a focus on increases in liver transaminase and hepatotoxicity. Methods: 677 levodopa-naïve patients with early stage Parkinson's disease (PD) were randomised to receive placebo or tolcapone 100 mg three times daily, added to standard doses of levodopa plus carbidopa or benserazide. Results: Increases in liver transaminase above the upper limit of normal (ULN) occurred in 69/342 (20.2%) and 92/335 (27.5%) patients in the placebo and tolcapone groups, respectively. Increases ≥3 times the ULN occurred in 4/342 (1.2%) and 6/335 (1.8%) patients receiving placebo and tolcapone, respectively (p=0.5). Liver transaminase values returned to normal in 65% of placebo and 80% of tolcapone treated patients. No instances of serious hepatotoxicity were seen. Diarrhoea was the most commonly reported AE-36/342 (11.0%) placebo v 98/335 (29.0%) tolcapone-and caused discontinuation in 9.9% of tolcapone treated patients. Overall, study discontinuation due to adverse effects was 2.9% in the placebo group and 17.3% in the tolcapone group. Conclusions: Tolcapone seemed to be safe and was generally well tolerated as an adjunctive treatment in patients starting treatment with carbidopa/levodopa for symptomatic PD. Mild increases in transaminase levels-<3 times the ULN-occurred commonly in both placebo and tolcapone treated patients, whereas potentially serious increases of up to ≥3 times the ULN were infrequent.
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Ratziu</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Hôpital Pitié-Salpêtrière, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author><author><name sortKey="Tolosa, E" sort="Tolosa, E" uniqKey="Tolosa E" first="E." last="Tolosa">E. Tolosa</name><affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Servicio Neurologia, Hospital Clinic Universitat de Barcelona, IDIBAPS</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>3 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName><orgName type="university">Université de Barcelone</orgName></affiliation></author><author><name sortKey="Oertel, W H" sort="Oertel, W H" uniqKey="Oertel W" first="W. H." last="Oertel">W. H. Oertel</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Philipps-Universitat</s1><s2>Marburg</s2><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">07-0382769</idno><date when="2007">2007</date><idno type="stanalyst">PASCAL 07-0382769 INIST</idno><idno type="RBID">Pascal:07-0382769</idno><idno type="wicri:Area/PascalFrancis/Corpus">000A18</idno><idno type="wicri:Area/PascalFrancis/Curation">000A15</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000855</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000855</idno><idno type="wicri:doubleKey">0022-3050:2007:Lees A:safety:and:tolerability</idno><idno type="wicri:Area/Main/Merge">002A68</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson's disease</title><author><name sortKey="Lees, A J" sort="Lees, A J" uniqKey="Lees A" first="A. J." last="Lees">A. J. Lees</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Reta Lila Weston Institute of Neurological Studies, University College London</s1><s2>London</s2><s3>GBR</s3><sZ>1 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><orgName type="university">University College de Londres</orgName></affiliation></author><author><name sortKey="Ratziu, V" sort="Ratziu, V" uniqKey="Ratziu V" first="V." last="Ratziu">V. Ratziu</name><affiliation wicri:level="4"><inist:fA14 i1="02"><s1>Hôpital Pitié-Salpêtrière, Université Pierre et Marie Curie</s1><s2>Paris</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Pierre-et-Marie-Curie</orgName></affiliation></author><author><name sortKey="Tolosa, E" sort="Tolosa, E" uniqKey="Tolosa E" first="E." last="Tolosa">E. Tolosa</name><affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Servicio Neurologia, Hospital Clinic Universitat de Barcelona, IDIBAPS</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>3 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName><orgName type="university">Université de Barcelone</orgName></affiliation></author><author><name sortKey="Oertel, W H" sort="Oertel, W H" uniqKey="Oertel W" first="W. H." last="Oertel">W. H. Oertel</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Philipps-Universitat</s1><s2>Marburg</s2><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author></analytic><series><title level="j" type="main">Journal of neurology, neurosurgery and psychiatry</title><title level="j" type="abbreviated">J. neurol. neurosurg. psychiatry</title><idno type="ISSN">0022-3050</idno><imprint><date when="2007">2007</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of neurology, neurosurgery and psychiatry</title><title level="j" type="abbreviated">J. neurol. neurosurg. psychiatry</title><idno type="ISSN">0022-3050</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Human</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Safety</term><term>Tolcapone</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term><term>Parkinson maladie</term><term>Sécurité</term><term>Tolcapone</term><term>Traitement</term><term>Homme</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Objective: The safety and tolerability of adjunctive tolcapone initiated simultaneously with levodopa was evaluated with a focus on increases in liver transaminase and hepatotoxicity. Methods: 677 levodopa-naïve patients with early stage Parkinson's disease (PD) were randomised to receive placebo or tolcapone 100 mg three times daily, added to standard doses of levodopa plus carbidopa or benserazide. Results: Increases in liver transaminase above the upper limit of normal (ULN) occurred in 69/342 (20.2%) and 92/335 (27.5%) patients in the placebo and tolcapone groups, respectively. Increases ≥3 times the ULN occurred in 4/342 (1.2%) and 6/335 (1.8%) patients receiving placebo and tolcapone, respectively (p=0.5). Liver transaminase values returned to normal in 65% of placebo and 80% of tolcapone treated patients. No instances of serious hepatotoxicity were seen. Diarrhoea was the most commonly reported AE-36/342 (11.0%) placebo v 98/335 (29.0%) tolcapone-and caused discontinuation in 9.9% of tolcapone treated patients. Overall, study discontinuation due to adverse effects was 2.9% in the placebo group and 17.3% in the tolcapone group. Conclusions: Tolcapone seemed to be safe and was generally well tolerated as an adjunctive treatment in patients starting treatment with carbidopa/levodopa for symptomatic PD. Mild increases in transaminase levels-<3 times the ULN-occurred commonly in both placebo and tolcapone treated patients, whereas potentially serious increases of up to ≥3 times the ULN were infrequent.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Espagne</li><li>France</li><li>Royaume-Uni</li></country><region><li>Angleterre</li><li>Catalogne</li><li>District de Giessen</li><li>Grand Londres</li><li>Hesse (Land)</li><li>Île-de-France</li></region><settlement><li>Barcelone</li><li>Londres</li><li>Marbourg</li><li>Paris</li></settlement><orgName><li>University College de Londres</li><li>Université Pierre-et-Marie-Curie</li><li>Université de Barcelone</li></orgName></list><tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Lees, A J" sort="Lees, A J" uniqKey="Lees A" first="A. J." last="Lees">A. J. Lees</name></region></country><country name="France"><region name="Île-de-France"><name sortKey="Ratziu, V" sort="Ratziu, V" uniqKey="Ratziu V" first="V." last="Ratziu">V. Ratziu</name></region></country><country name="Espagne"><region name="Catalogne"><name sortKey="Tolosa, E" sort="Tolosa, E" uniqKey="Tolosa E" first="E." last="Tolosa">E. Tolosa</name></region></country><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Oertel, W H" sort="Oertel, W H" uniqKey="Oertel W" first="W. H." last="Oertel">W. H. Oertel</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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