Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson’s disease
Identifieur interne : 002093 ( Istex/Curation ); précédent : 002092; suivant : 002094Safety 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 & Psychiatry [ 0022-3050 ] ; 2007-09.
English descriptors
- KwdEn :
- AEs, adverse events, ALT, alanine aminotransferase, AST, aspartate aminotransferase, COMT, catechol-O-methyltransferase, PD, Parkinson’s disease, Parkinson’s disease, ULN, upper limit of normal, UPDRS, Unified Parkinson’s Disease Rating Scale, adverse events, hepatoxicity, levodopa, liver transaminases, tolcapone.
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.
Url:
DOI: 10.1136/jnnp.2006.097154
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Ratziu</name><affiliation wicri:level="1"><mods:affiliation>Hôpital Pitié-Salpêtrière, Université Pierre et Marie Curie, Paris, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Pitié-Salpêtrière, Université Pierre et Marie Curie, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Tolosa, E" sort="Tolosa, E" uniqKey="Tolosa E" first="E" last="Tolosa">E. 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Ratziu</name><affiliation wicri:level="1"><mods:affiliation>Hôpital Pitié-Salpêtrière, Université Pierre et Marie Curie, Paris, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Pitié-Salpêtrière, Université Pierre et Marie Curie, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Tolosa, E" sort="Tolosa, E" uniqKey="Tolosa E" first="E" last="Tolosa">E. Tolosa</name><affiliation wicri:level="1"><mods:affiliation>Servicio Neurologia, Hospital Clinic Universitat de Barcelona, IDIBAPS, Barcelona, Spain</mods:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Servicio Neurologia, Hospital Clinic Universitat de Barcelona, IDIBAPS, Barcelona</wicri:regionArea></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="1"><mods:affiliation>Philipps-Universitat, Marburg, Germany</mods:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Philipps-Universitat, Marburg</wicri:regionArea></affiliation></author></analytic><monogr></monogr><series><title level="j">Journal of Neurology, Neurosurgery & Psychiatry</title><title level="j" type="abbrev">J Neurol Neurosurg Psychiatry</title><idno type="ISSN">0022-3050</idno><idno type="eISSN">1468-330X</idno><imprint><publisher>BMJ Publishing Group Ltd</publisher><date type="published" when="2007-09">2007-09</date><biblScope unit="volume">78</biblScope><biblScope unit="issue">9</biblScope><biblScope unit="page" from="944">944</biblScope></imprint><idno type="ISSN">0022-3050</idno></series><idno type="istex">6DE29BEE87940A31FC2E1846BC5C3A12EB29AADC</idno><idno type="DOI">10.1136/jnnp.2006.097154</idno><idno type="href">jnnp-78-944.pdf</idno><idno type="PMID">17098835</idno><idno type="local">0780944</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0022-3050</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>AEs, adverse events</term><term>ALT, alanine aminotransferase</term><term>AST, aspartate aminotransferase</term><term>COMT, catechol-O-methyltransferase</term><term>PD, Parkinson’s disease</term><term>Parkinson’s disease</term><term>ULN, upper limit of normal</term><term>UPDRS, Unified Parkinson’s Disease Rating Scale</term><term>adverse events</term><term>hepatoxicity</term><term>levodopa</term><term>liver transaminases</term><term>tolcapone</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></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></record>Pour manipuler ce document sous Unix (Dilib)
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