Objective: To evaluate the effect of opicapone (OPC) 50 mg versus entacapone (ENT) on early morning-OFF (EMO) pattern.

Background:
OPC, a once-daily catechol-O-methyltransferase inhibitor, was shown to be effective for end-of-dose motor fluctuations in Parkinson’s disease (PD) patients in two large multinational trials (BIPARK-I and II) [1, 2].

Method: Home-diary data from patients with wearing-OFF treated with OPC 50 mg or ENT in the BIPARK-I trial [1] were analyzed. Patients’ 24-h diary data were stratified per daily hour. Asleep and ON/OFF fluctuations were characterized and depicted by daily hour. Proportion of patients who woke up in ON-/OFF-status and time-to-ON from first morning levodopa intake after wake-up were analyzed after a continuous period of >/=4 hours of sleep. EMO pattern was defined as the morning period for which %/h asleep-time was (1) not negligible (<5%/h), (2) <50%/h and (3) <%/h OFF-time.

Results: A total of 235 patients were included in the analysis. For both treatments, at baseline and endpoint, the majority of asleep-time (>50%/h) was within 11pm to 6am (Figures 1A, 1B, 2A and 2B) and the proportions of patients taking levodopa per daily-hour were comparable (Figures 1C and 2C). Asleep-time was considered negligible (<5%/h) from 9am–9pm (Figures 1A, 1B, 2A and 2B). At baseline, <15% of patients woke up in ON-status, time-to-ON was >1h and EMO pattern was found to be between 6am to 8am (Figures 1A and 2A). At endpoint, for OPC 50 mg, the proportion of patients who woke up in ON-status increased by 12.2% from baseline, in comparison with 7.5% for ENT. For patients treated with OPC 50 mg, time-to-ON decreased by 17.7%, in comparison with 1.9% for ENT. As reduction of morning OFF-time (%/h) was two-fold greater for OPC 50 mg versus ENT (20% vs 10%), no EMO was observed for OPC 50 mg, but EMO was still observed for ENT (Figures 1B and 2B).

Conclusion: Treatment with OPC, in comparison with ENT, led to a greater increase in the proportion of patients who woke up in ON-status and a greater decrease in time-to-ON from first morning levodopa intake. In addition, due to a substantial reduction in morning OFF-time, no EMO pattern was found for patients treated with OPC, in contrast to ENT.

References: 1. Ferreira JJ, et al. Lancet Neurol. 2016;15:154–65. 2. Lees AJ, et al. JAMA Neurol. 2017;74:197–206.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/effect-of-opicapone-and-entacapone-on-early-morning-off-pattern-in-parkinsons-disease-patients-with-motor-fluctuations/