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Safety and tolerability of adjunctive Tolcapone therapy in early Parkinson's disease patients
  1. A J Lees (alees{at}ion.ucl.ac.uk)
  1. Reta Lila Weston Institute of Neurological Studies, United Kingdom
    1. Vlad Ratziu
    1. Hôpital Pitié-Salpêtrière, Université Pierre et Marie Curie, France
      1. Eduardo Tolosa (etolosa{at}clinic.ub.es)
      1. Servicio Neurologia, Hospital Clinic Universitat de Barcelona, IDIBAPS, Spain
        1. Wolfgang H Oertel
        1. Philipps-Universitat, Germany

          Abstract

          Purpose: The safety and tolerability of adjunctive tolcapone initiated simultaneously with levodopa was evaluated with a focus on liver transaminase elevations and hepatotoxicity.

          Methods: 677 levodopa-naïve patients with early-stage Parkinson’s disease (PD) were randomized to receiveplacebo or tolcapone 100 mg three times daily, added to standard doses of levodopa plus carbidopa or benserazide.

          Results: Liver transaminase elevations above the upper limit of normal (ULN) occurred in 20.2% and 27.5% of patients in the placebo and tolcapone groups, respectively. Elevations >=3 times the ULN occurred in 1.2% and 1.8% of placebo and tolcapone patients, respectively (p = 0.52). Liver transaminase values returned to the normal range in 65% of placebo- and 80% of tolcapone-treated patients. No instances of serious hepatotoxicity were observed. Diarrhea was the most frequently reported AE—11% (36/342) placebo vs. 29% (98/335) tolcapone—and caused discontinuation in 9.9% of tolcapone-treated patients. Overall, study discontinuation due to AEs was 2.9% in the placebo group and 17.3% in the tolcapone group.

          Conclusions: Tolcapone appeared safe and was generally well tolerated as adjunctive therapy in patients initiating treatment with carbidopa/levodopa for symptomatic PD. Mild elevations in transaminase levels—<3 times the ULN—occurred commonly in both placebo- and tolcapone-treated patients, whereas potentially serious elevations to ≥3 times the ULN were infrequent.

          • Parkinson's disease
          • Tolcapone
          • diarrhea
          • levodopa
          • liver transaminases

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