Objective: To evaluate safety and tolerability of opicapone as an add‐on treatment to levodopa in Parkinson’s disease (PD) patients.

Background: Opicapone is a recently approved adjunctive treatment to levodopa/carbidopa in PD patients with motor fluctuations. Several studies have shown that opicapone elicits a significant reduction of end-of-dose motor fluctuations without worsening the percentage of troublesome dyskinesias. A discontinuation rate of 11.9% has been reported in previous clinical trials.

Method: Observational, retrospective, unicenter cohort study that included PD patients who started opicapone according to clinical practice. Demographic clinical data, withdrawal of treatment and reasons of discontinuation were collected.

Results: 68 PD patients (29 women, mean age 68.4 years and mean disease duration of 12.14 years) who started opicapone between December 2017 and December 2018 were recruited in La Fe Universitary Hospital (Valencia, Spain). 60 patients (88.23%) suffered from motor fluctuations previous to opicapone onset. Before this treatment, 20 patients (29.41%) experienced dyskinesias, 14 patients (20.58%) reported cognitive decline, 14 (20.58%) described hallucinations and 10 (14.7%) had experienced some kind of impulse control disorder in the past. After the introduction of opicapone, 46 patients (67.64%) reported an improvement on motor fluctuations and are still carrying on with the treatment. Of them, 43 patients (93.47%) described a good response. Reasons for withdrawal were: 8 patients (11.67%) due to gastrointestinal side effects, 5 patients (7.35%) because of lack of benefit, 3 (4.41%) due to psychiatric issues, 2 (2.68%) because of sleepiness, 1 (1.47%) on account of dyskinesias, and 1(1.47%) stopped the treatment because of dizziness. None of the patients withdrew the treatment as a consequence of cognitive deterioration.

Conclusion: Our results point out that opicapone is an overall well tolerated treatment. The majority of our patients showed clinical improvement and they keep taking opicapone nowadays. Our rate of withdrawal (11.6%) does not differ from the previous publications. The main reason for discontinuation in our study cohort was gastrointestinal side effects. Even in patients with cognitive complains opicapone seems to be a safe treatment.

References: (1)‐ Fabbri M, Rosa MM, Ferreira JJ. Clinical pharmacology review of opicapone for the treatment of Parkinson’s disease. Neurodegener Dis Manag. 2016. (2)‐ Ferreira JJ, Rocha JF, Falcao A, Santos A, Pinto R, Nunes T and Soares-da-Silva P. Effect of opicapone on levodopa pharmacokinetics, catechol-O-methyltransferase activity and motor fluctuations in patients with Parkinson`s Disease. European Journal of Neurology 2015. (3)-Ferreira JJ, Lees A, Rocha JF, Poewe W, Rascol O, Soares-da-silva P, for the BIPARK1 investigators. Opicapone as an adjunt to levodopa in patients with Parkinson´s disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurology 2015. (4)- Lees AJ, Ferrerira J, Rascol O, Poewe W, Rocha JF, McCrory M, Soares-da-Silva P, for the BIPARK2 investigators. Opicapone as adjunct to Levodopa Therapy in Patients with Parkinson Disease and Motor Fluctuations. A Randomized Clinical Tiral, JAMA Neurology 2016.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-and-tolerability-of-opicapone-in-parkinsons-disease/