Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson's disease
Identifieur interne : 000297 ( Pmc/Curation ); précédent : 000296; suivant : 000298Safety 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 ] ; 2006.
Abstract
The safety and tolerability of adjunctive tolcapone initiated simultaneously with levodopa was evaluated with a focus on increases in liver transaminase and hepatotoxicity.
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.
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
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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DOI: 10.1136/jnnp.2006.097154
PubMed: 17098835
PubMed Central: 2117861
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<front><journal-meta><journal-id journal-id-type="nlm-ta">J Neurol Neurosurg Psychiatry</journal-id><journal-title>Journal of Neurology, Neurosurgery, and Psychiatry</journal-title><issn pub-type="ppub">0022-3050</issn><issn pub-type="epub">1468-330X</issn><publisher><publisher-name>BMJ Group</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">17098835</article-id><article-id pub-id-type="pmc">2117861</article-id><article-id pub-id-type="publisher-id">jn97154</article-id><article-id pub-id-type="doi">10.1136/jnnp.2006.097154</article-id><article-categories><subj-group subj-group-type="heading"><subject>Paper</subject></subj-group></article-categories><title-group><article-title>Safety and tolerability of adjunctive tolcapone treatment in patients with early Parkinson's disease</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Lees</surname><given-names>A J</given-names></name></contrib><contrib contrib-type="author"><name><surname>Ratziu</surname><given-names>V</given-names></name></contrib><contrib contrib-type="author"><name><surname>Tolosa</surname><given-names>E</given-names></name></contrib><contrib contrib-type="author"><name><surname>Oertel</surname><given-names>W H</given-names></name></contrib></contrib-group><aff><bold>A J Lees</bold>, Reta Lila Weston Institute of Neurological Studies, University College London, London, UK</aff><aff><bold>V Ratziu</bold>, Hôpital Pitié‐Salpêtrière, Université Pierre et Marie Curie, Paris, France</aff><aff><bold>E Tolosa</bold>, Servicio Neurologia, Hospital Clinic Universitat de Barcelona, IDIBAPS, Barcelona, Spain</aff><aff><bold>W H Oertel</bold>, Philipps‐Universitat, Marburg, Germany</aff><author-notes><corresp>Correspondence to: Dr A J Lees<break></break>Reta Lila Weston Institute for Neurological Studies, University College London, 1 Wakefield St, London WC1N 1PJ, UK;
alees@ion.ucl.ac.uk</corresp></author-notes><pub-date pub-type="ppub"><month>9</month><year>2007</year></pub-date><pub-date pub-type="epub"><day>20</day><month>11</month><year>2006</year></pub-date><volume>78</volume><issue>9</issue><fpage>944</fpage><lpage>948</lpage><history><date date-type="received"><day>5</day><month>5</month><year>2006</year></date><date date-type="rev-recd"><day>20</day><month>9</month><year>2006</year></date><date date-type="accepted"><day>18</day><month>10</month><year>2006</year></date></history><permissions><copyright-statement>Copyright © 2007 BMJ Publishing Group Ltd</copyright-statement></permissions><abstract><sec><title>Objective</title><p>The safety and tolerability of adjunctive tolcapone initiated simultaneously with levodopa was evaluated with a focus on increases in liver transaminase and hepatotoxicity.</p></sec><sec><title>Methods</title><p>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.</p></sec><sec><title>Results</title><p>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 <italic>v</italic> 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.</p></sec><sec><title>Conclusions</title><p>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.</p></sec></abstract><kwd-group><kwd>tolcapone</kwd><kwd>levodopa</kwd><kwd>Parkinson's disease</kwd><kwd>liver transaminases</kwd><kwd>hepatoxicity</kwd><kwd>adverse events</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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