Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson's disease
Identifieur interne : 000A18 ( PascalFrancis/Corpus ); précédent : 000A17; suivant : 000A19Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson's disease
Auteurs : A. J. Lees ; V. Ratziu ; E. Tolosa ; W. H. OertelSource :
- Journal of neurology, neurosurgery and psychiatry [ 0022-3050 ] ; 2007.
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- Pascal (Inist)
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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Pour connaître la documentation sur le format Inist Standard.
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Format Inist (serveur)
NO : | PASCAL 07-0382769 INIST |
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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:07-0382769Le 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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<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>
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<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>
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