ParkinsonFranceV1, PascalFrancis, Corpus, bibRecord, 000A18

Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson's disease

Identifieur interne : 000A18 ( PascalFrancis/Corpus ); précédent : 000A17; suivant : 000A19

Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson's disease

Auteurs : A. J. Lees ; V. Ratziu ; E. Tolosa ; W. H. Oertel

Source :

Journal of neurology, neurosurgery and psychiatry [ 0022-3050 ] ; 2007.

RBID : Pascal:07-0382769

Descripteurs français

Pascal (Inist)
- Système nerveux pathologie, Parkinson maladie, Sécurité, Tolcapone, Traitement, Homme.

English descriptors

KwdEn :
- Human, Nervous system diseases, Parkinson disease, Safety, Tolcapone, Treatment.

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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A11	`01`	`1`		`@1 LEES (A. J.)`
A11	`02`	`1`		`@1 RATZIU (V.)`
A11	`03`	`1`		`@1 TOLOSA (E.)`
A11	`04`	`1`		`@1 OERTEL (W. H.)`
A14	`01`			`@1 Reta Lila Weston Institute of Neurological Studies, University College London @2 London @3 GBR @Z 1 aut.`
A14	`02`			`@1 Hôpital Pitié-Salpêtrière, Université Pierre et Marie Curie @2 Paris @3 FRA @Z 2 aut.`
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A14	`04`			`@1 Philipps-Universitat @2 Marburg @3 DEU @Z 4 aut.`
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A21				`@1 2007`
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A43	`01`			`@1 INIST @2 6015 @5 354000150033540050`
A44				`@0 0000 @1 © 2007 INIST-CNRS. All rights reserved.`
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C01	`01`		`ENG`	@0 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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Format Inist (serveur)

NO :	PASCAL 07-0382769 INIST
ET :	Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson's disease
AU :	LEES (A. J.); RATZIU (V.); TOLOSA (E.); OERTEL (W. H.)
AF :	Reta Lila Weston Institute of Neurological Studies, University College London/London/Royaume-Uni (1 aut.); Hôpital Pitié-Salpêtrière, Université Pierre et Marie Curie/Paris/France (2 aut.); Servicio Neurologia, Hospital Clinic Universitat de Barcelona, IDIBAPS/Barcelona/Espagne (3 aut.); Philipps-Universitat/Marburg/Allemagne (4 aut.)
DT :	Publication en série; Niveau analytique
SO :	Journal of neurology, neurosurgery and psychiatry; ISSN 0022-3050; Coden JNNPAU; Royaume-Uni; Da. 2007; Vol. 78; No. 9; Pp. 944-948; Bibl. 17 ref.
LA :	Anglais
EA :	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.
CC :	002B17; 002B17G; 002B17A03
FD :	Système nerveux pathologie; Parkinson maladie; Sécurité; Tolcapone; Traitement; Homme
FG :	Encéphale pathologie; Extrapyramidal syndrome; Maladie dégénérative; Système nerveux central pathologie
ED :	Nervous system diseases; Parkinson disease; Safety; Tolcapone; Treatment; Human
EG :	Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease
SD :	Sistema nervioso patología; Parkinson enfermedad; Seguridad; Tolcapona; Tratamiento; Hombre
LO :	INIST-6015.354000150033540050
ID :	07-0382769

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Pascal:07-0382769

Le document en format XML

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<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>
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<fC01 i1="01" l="ENG"><s0>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.</s0>
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<server><NO>PASCAL 07-0382769 INIST</NO>
<ET>Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson's disease</ET>
<AU>LEES (A. J.); RATZIU (V.); TOLOSA (E.); OERTEL (W. H.)</AU>
<AF>Reta Lila Weston Institute of Neurological Studies, University College London/London/Royaume-Uni (1 aut.); Hôpital Pitié-Salpêtrière, Université Pierre et Marie Curie/Paris/France (2 aut.); Servicio Neurologia, Hospital Clinic Universitat de Barcelona, IDIBAPS/Barcelona/Espagne (3 aut.); Philipps-Universitat/Marburg/Allemagne (4 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Journal of neurology, neurosurgery and psychiatry; ISSN 0022-3050; Coden JNNPAU; Royaume-Uni; Da. 2007; Vol. 78; No. 9; Pp. 944-948; Bibl. 17 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002B17; 002B17G; 002B17A03</CC>
<FD>Système nerveux pathologie; Parkinson maladie; Sécurité; Tolcapone; Traitement; Homme</FD>
<FG>Encéphale pathologie; Extrapyramidal syndrome; Maladie dégénérative; Système nerveux central pathologie</FG>
<ED>Nervous system diseases; Parkinson disease; Safety; Tolcapone; Treatment; Human</ED>
<EG>Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease</EG>
<SD>Sistema nervioso patología; Parkinson enfermedad; Seguridad; Tolcapona; Tratamiento; Hombre</SD>
<LO>INIST-6015.354000150033540050</LO>
<ID>07-0382769</ID>
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	La maladie de Parkinson en France (serveur d'exploration)
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La maladie de Parkinson en France (serveur d'exploration)

Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson's disease

Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson's disease

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