Effectiveness and safety of opicapone in Parkinson’s disease patients with motor fluctuations: the OPTIPARK open-label study

Background The efficacy and safety of opicapone, a once-daily catechol-O-methyltransferase inhibitor, have been established in two large randomized, placebo-controlled, multinational pivotal trials. Still, clinical evidence from routine practice is needed to complement the data from the pivotal trials. Methods OPTIPARK (NCT02847442) was a prospective, open-label, single-arm trial conducted in Germany and the UK under clinical practice conditions. Patients with Parkinson’s disease and motor fluctuations were treated with opicapone 50 mg for 3 (Germany) or 6 (UK) months in addition to their current levodopa and other antiparkinsonian treatments. The primary endpoint was the Clinician’s Global Impression of Change (CGI-C) after 3 months. Secondary assessments included Patient Global Impressions of Change (PGI-C), the Unified Parkinson’s Disease Rating Scale (UPDRS), Parkinson’s Disease Questionnaire (PDQ-8), and the Non-Motor Symptoms Scale (NMSS). Safety assessments included evaluation of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Results Of the 506 patients enrolled, 495 (97.8%) took at least one dose of opicapone. Of these, 393 (79.4%) patients completed 3 months of treatment. Overall, 71.3 and 76.9% of patients experienced any improvement on CGI-C and PGI-C after 3 months, respectively (full analysis set). At 6 months, for UK subgroup only (n = 95), 85.3% of patients were judged by investigators as improved since commencing treatment. UPDRS scores at 3 months showed statistically significant improvements in activities of daily living during OFF (mean ± SD change from baseline: − 3.0 ± 4.6, p < 0.0001) and motor scores during ON (− 4.6 ± 8.1, p < 0.0001). The mean ± SD improvements of − 3.4 ± 12.8 points for PDQ-8 and -6.8 ± 19.7 points for NMSS were statistically significant versus baseline (both p < 0.0001). Most of TEAEs (94.8% of events) were of mild or moderate intensity. TEAEs considered to be at least possibly related to opicapone were reported for 45.1% of patients, with dyskinesia (11.5%) and dry mouth (6.5%) being the most frequently reported. Serious TEAEs considered at least possibly related to opicapone were reported for 1.4% of patients. Conclusions Opicapone 50 mg was effective and generally well-tolerated in PD patients with motor fluctuations treated in clinical practice. Trial registration Registered in July 2016 at clinicaltrials.gov (NCT02847442)

Begrenzte Wahl – Gelegenheitsstrukturen und Erwerbsmuster in Paarhaushalten im europäischen Vergleich

Dieser Artikel untersucht Erwerbsmodelle in Paarhaushalten – insbesondere deren Variabilität je nach Präsenz und Alter von Kindern. Ziel der vergleichenden Analyse von 10 europäischen Ländern auf Basis des European Social Survey (2004/05 und 2006/07) ist die Erklärung der ausgeprägten Länderunterschiede sowohl im Hinblick auf empirisch bedeutsame Erwerbsmuster, vor allem jedoch hinsichtlich deren Veränderung über den Lebenszyklus von Familien. Als Erklärungsfaktoren werden sowohl wohlfahrtsstaatliche Regelungen (Familien- und Steuerpolitiken) und sozioökonomische Bedingungen (Lohnniveau, Arbeitslosigkeit, Verfügbarkeit von Teilzeitarbeit) als auch kulturelle Faktoren (gesellschaftlich dominante Werthaltungen in Bezug auf Geschlechterrollen und Kleinkindbetreuung) untersucht. Der Artikel diskutiert das Verhältnis dieser strukturellen und kulturellen Faktoren zur Praxis gelebter Erwerbsmuster in Paarhaushalten und kommt dabei zu dem Schluss, dass die Erklärung geschlechtsspezifischer Erwerbsmuster letztlich von Land zu Land unterschiedlich ausfallen muss, um der Komplexität ihrer Genesis gerecht zu werden

Limited choice : structures of opportunity and employment patterns in European couple households

This article investigates employment patterns in couple households - and in particular their variability according to the presence and age of children. The aim of the comparative analysis of ten European countries, using data from the European Social Survey (2004/05 and 2006/07), is to explain the pronounced cross-country differences with regard to empirically relevant household employment patterns—focusing on their variability across an ideal-typical family life-cycle. Explanatory factors include the social policy framework (family and tax policies), socio-economic and labor market conditions (wage level, unemployment, the availability of part-time work) as well as national gender cultures (societal ideals regarding gender roles and childcare). The article discusses the relationship between these structural and cultural factors, on the one hand, and actual practices of gendered employment behaviour, on the other. It concludes that, in order to account for the complexity of causal relations, the explanation of gendered employment patterns ought to be country-specific