Objective: To evaluate retrospectively the treatment with the novel COMT-inhibitor opicapone (OPC) in a tertiary Parkinson Center the first year after its approval in Germany

Background: Oral opicapone (Ongentys(®), a potent, third-generation, long-acting, peripheral catechol-O-methyltransferase (COMT) inhibitor, is approved as adjunctive treatment to levodopa therapy in adults with Parkinson’s disease (PD) and end-of-dose motor fluctuations who cannot be stabilized.

Methods: We used an industry-independent, non-interventional retrospective evaluation based on standardized records and the medical documentation of the institution. All PD patients who received OPC between September 2016 and October 2017 were included. Frequency of OPC treatment, indication, premedication with entcapone or tolcapone, use of other dopaminergic drugs, adverse events (AE), and retention rate were analysed.

Results: 90/687 (13.1%) patients (41 female) with a mean age of 69 (13.8) ys were treated with OPC during the observational period. Duration of PD in the opicapone group was 10.4 (7.3) ys (range 3 – 24 ys) with a Hoehn & Yahr (H&Y) I-II in 14, H&Y III-IV in 62 and H&Y V in 14 patients. Associated dementia of various degrees was described in 18/90. 84/90 (93.3%) patients had a history of COMT inhibitor pretreament (80 entacapone, 4 tolcapone and entacapone), of these 28 had a history of entacapone intolerance. The remaing 56 patients were still on a COMT inhibitor but had motor or non-motor fluctuations. Thus 56 patients were shifted from a COMT inhibitor to OPC. 34 (of whom 13 had a history of entacapone intolerance) were started on OPC directly. Gastointestinal AE were not described in any of the patients on OPC. Dyskinesia were frequent (17/90; 18.9%). Disabling dyskinesia were most prominent 2 weeks after the beginning of opicapone. 5/90 (5.6%) patients developed hallucinations or psychosis, dizziness was reported in 2 patients. The retention rate at the end of the evaluation period was 87.2%. Reduction in off time or UPDRS III was documented in 62/90 (68.9%). Liver enzymes were normal in all patients.

Conclusions: Opicapone was well tolerated in most PD patients with a documented benefit in two thirds. Dyskinesia were prominent in a relevant number of patients if levodopa was not reduced. The intensity of dyskinesia was accelerating during the first two weeks of OPC treatment. None of our patients reported relevant gastrointestinal symptoms, liver enzymes were not elevated.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-single-center-retrospective-analysis-of-opicapone-treatment-in-90-parkinson-patients/