Abstract
To compare the efficacy and safety of levodopa/carbidopa/entacapone (LCE) with levodopa/carbidopa (LC) on Parkinson’s disease (PD) patients with mild, or only minimally disabling motor complications. A prospective 3-month, multicentre, parallel-group, double-blind, and randomised phase IV study was performed. The primary endpoint was to assess the efficacy of LCE compared to LC on ADLs using the UPDRS part II. Secondary endpoints were assessed by the UPDRS (I, III and IV) scores, QUICK and PDQ-39 questionnaires, and patient and investigator clinical global impression (CGI). Ninety-five patients were randomly assigned to treatment with LCE (100/25/200 or 150/37.5/200 mg tablets, n = 46) or LC (100/25 mg tablets, n = 49), at the same levodopa dose that were administered before randomization. Treatment with LCE resulted in significantly greater improvement in UPDRS part II (ADLs) scores compared to treatment with LC (adjusted mean difference between groups of −1.5 points) (p = 0.0288). Amelioration was also observed in UPDRS part III scores (p = 0.010), and CGI (patient and investigator) scores (p = 0.015, and p = 0.028, respectively). LCE and LC were generally well tolerated with 78 % of subjects completing the study. Most AEs (50 % in LCE and 71.4 % in LC) were classified as mild. No serious AEs were related to the treatment. Treatment with LCE results in improved efficacy compared to LC in PD patients with mild, or minimally disabling motor fluctuations, maintaining a good safety and tolerability profile.
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Acknowledgments
This study was supported by Novartis, S.A. Editorial assistance was supported by Montserrat Sabaté and biostatistics by Emma Albacar from Trial Form Support.
This study has been conducted by the above-signed authors and the DERBI study group (in alphabetical order): Adolfo Minguez, Àngels Bayés, Carlos Leiva, Ernest Balaguer, Esther Cubo, Francesc Miquel, Francisco Vivancos, Jose Juni, Juan Andrés Bruguera, Lydia Vela, Matilde Calopa, Maria José Catalán, Mariateresa Buongiorno, Miguel Aguilar, and Oriol de Fàbregues.
Conflict of interest
Hernández B is employee of Novartis S.A. This study was supported by Novartis, S.A.
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Tolosa, E., Hernández, B., Linazasoro, G. et al. Efficacy of levodopa/carbidopa/entacapone versus levodopa/carbidopa in patients with early Parkinson’s disease experiencing mild wearing-off: a randomised, double-blind trial. J Neural Transm 121, 357–366 (2014). https://doi.org/10.1007/s00702-013-1114-x
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DOI: https://doi.org/10.1007/s00702-013-1114-x