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)

Healthy ageing at work— Efficacy of group interventions on the mental health of nurses aged 45 and older: Results of a randomised, controlled trial

<div><p>Objective</p><p>This multicentre, randomised controlled trial (RCT) aimed to evaluate the efficacy of a small-group intervention promoting successful ageing at work in older nurses (aged ≥45).</p><p>Method</p><p>A sample of 115 nurses aged ≥45 from 4 trial sites in Germany were randomly assigned to either the intervention group (IG), that received a small-group intervention of seven weekly sessions of 120 min with a booster session after six weeks or to a wait-list control condition (WLC). Outcomes were measured via validated self-report questionnaires at baseline (T1) and at post-treatment (T2).</p><p>Primary outcomes were mental health-related well-being and mental health-related quality of life (QOL). The secondary outcomes included mental health-related and work-related measures.</p><p>Results</p><p>The intention to treat (ITT) analysis showed significant positive effects of the intervention on mental health. A significant small effect (d = 0.3) in favour of the IG was found for psychological health-related quality of life. Positive small effects (d = 0.24 to d = 0.31) were also found for work related mental strain.</p><p>Conclusions</p><p>Our small-group intervention based on a theory of successful ageing for nurses aged ≥45 was found to be effective with regard to improvements of psychological health related quality of life and other mental health-related outcomes. Thus, our study shows that the ageing workforce can be reached through specifically designed preventive interventions. The components of our intervention could be easily adapted to the belongings of other professions. Our results suggest that these components should be evaluated in various settings outside the healthcare sector.</p></div

Diabetes care in pediatric refugees from Africa or Middle East - experiences from Germany and Austria based on real-world data from the DPV registry.

Prinz N, Konrad K, Brack C, et al. Diabetes care in pediatric refugees from Africa or Middle East - experiences from Germany and Austria based on real-world data from the DPV registry. European journal of endocrinology. 2019;181(1):31-38.OBJECTIVE: With increasing migration to Europe, diabetes diagnosis and treatment of refugees became challenging. To describe current experience with pediatric refugees in Germany and Austria.; DESIGN AND METHODS: 43,137 patients (<21 years) with type 1 diabetes from the diabetes patient follow-up registry (DPV) were studied, and divided by refugee status into patients born in Middle East (n=365) or Africa (n=175) and native patients (child and parents born in Germany/Austria; G/A: n=42,597). Groups were compared using multivariable regression adjusted for age, sex and diabetes duration (SAS 9.4). In refugees the first year after arrival was studied, and for native children the most recent year of care.; RESULTS: After adjustment, HbA1c was highest in refugees (ME vs. AFR vs. G/A: 72.3±1.0 vs. 75.0±1.4 vs. 66.0±0.1 mmol/mol, each p<0.001) and microalbuminuria (9.9 vs 13.6 vs. 6.5%, each p<0.05) was more prevalent. African children experienced severe hypoglycemia (17.8±4.3 vs. 25.4±8.7 vs. 11.5±0.3 per 100 patient years) significantly more often, whereas hypoglycemia with coma (5.1±1.1 vs. 4.1±1.6 vs. 2.6±0.1 per 100 patient years) and retinopathy (2.1 vs. n/a vs. 0.2%) were significantly more common in children from Middle East compared to natives. Insulin pumps were used in a markedly larger proportion of native patients (7.4 vs. 13.2 vs. 43.0%, each p<0.001).; CONCLUSIONS: A relevant number of pediatric refugees with type 1 diabetes are treated in German/Austrian diabetes clinics. Refugee children, parents and caregivers are faced with several problems in diabetes therapy and outcome that should be addressed more intensively by pediatric diabetes teams

CONSORT 2010 flow diagram: Healthy ageing at work.

<p>CONSORT 2010 flow diagram: Healthy ageing at work.</p

Baseline characteristics (T1) of participants of the intervention group (IG) and waiting list control (WLC) group.

<p>Baseline characteristics (T1) of participants of the intervention group (IG) and waiting list control (WLC) group.</p

Means and SD of outcome variables and baseline (T1) and follow-up (T2) (IG and WLC).

<p>Means and SD of outcome variables and baseline (T1) and follow-up (T2) (IG and WLC).</p

Results of the ANCOVA for primary and secondary outcomes.

<p>Results of the ANCOVA for primary and secondary outcomes.</p