EAN 2022 | Opicapone versus entacapone for early morning dystonia in Parkinson’s disease
Fabrizio Stocchi, MD, PhD, IRCCS San Raffaele Rome, Sapienza University of Rome, Rome, Italy, presents the findings of a post-hoc analysis of the BIPARK-I study (NCT01568073), assessing the efficacy of opicapone versus entacapone in treating early morning dystonia (EMD). The pivotal BIPARK-I study investigated various doses of opicapone as an adjunct to levodopa in patients with Parkinson’s disease and end-of-dose motor fluctuations. Both opicapone and entacapone, the active comparator, were superior to placebo in reducing off time. In this post-hoc analysis, the effect of 50mg opicapone on EMD was compared to entacapone. Opicapone was associated with a significant improvement in early morning dystonia, showing an 8.5-fold increase in the likelihood of becoming EMD-free, compared to those on entacapone. This interview took place at the European Academy of Neurology (EAN) 2022 Congress in Vienna, Austria.
Transcript (edited for clarity)
Yeah, the BIPARK-I was a pivotal trial for opicapone. Opicapone is a catechol-O-methyltransferase inhibitor, which was in fact tested in two main pivotal trials: BIPARK-I and BIPARK-II . In BIPARK-I, there was also in there, different groups of patients. Two actually was treated with opicapone, one with entacapone, and one with placebo. So there is also an indirect comparison versus the other catechol-O-methyltransferase inhibitor, entacapone...
Yeah, the BIPARK-I was a pivotal trial for opicapone. Opicapone is a catechol-O-methyltransferase inhibitor, which was in fact tested in two main pivotal trials: BIPARK-I and BIPARK-II . In BIPARK-I, there was also in there, different groups of patients. Two actually was treated with opicapone, one with entacapone, and one with placebo. So there is also an indirect comparison versus the other catechol-O-methyltransferase inhibitor, entacapone. So, in BIPARK-I, showed that both drugs were superior to placebo in reducing OFF time. So improving time ON in patient with PD.
In this post-hoc analysis, we analyzed the effect of the drugs on a particular symptom, which is early morning akinesia. Early morning akinesia can be a very distressing and difficult symptom for patients, because appear early in the morning and is actually troublesome and painful. So the patient cannot stand up because of the dystonia of the foot.
So, we analyze the patient suffering from this symptom and out of this patient, a larger percent of them treated with opicapone improved, around 70%, whereas much less with entacapone. The other aspect which was analyzed was if the patient during the study developed early morning dystonia, but there was no difference between the two groups, very few patients developed early morning dystonia during the study. So in conclusion, opicapone was superior to entacapone in treating existing early morning dystonia.
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Disclosures
Chiesi Ltd., GlaxoSmithKline Plc., Impax Laboratories Inc., Lundbeck Ltd, Teva UK Limited, UCB Pharma Ltd, Merck & Co. Inc, Zambon Pharma, Novartis AG, Sunovion, Neuroderm, Abbvie, Britannia, Lusofarmaco, Ever pharma, BIAL pharma, ROCHE, BIOGEN, IRLAB
