Motivations and Needs of Older People for Work and Active Lifestyle

The article presents the results of a poll of older people on the example of a particular region (The Tomsk Region) to identify the need for an active lifestyle and penchant for productive work. The system ofhypotheses under article issues is tested. The aim of the work is to analyze problems of older people which affect their labor activity.The empirical base for the study was the results of the survey (sample frame 400 pers.). The respondents were older people living in urban and rural areas of the Tomsk Region. To test the generated hypothesesstatistical methods (analysis of variance, correlation analysis, etc.) are used. There are three main problems the elderly related to their needs and inclinations to work. It was determined that the formationof a stable demand of older people in productive work and active lifestyle will help to solve a number of problems of socio-psychological and economic nature at the present stage of social development inRussia and abroad

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)

Patients' perception of Parkinson's disease-associated pain following initiation of rotigotine: a multicenter non-interventional study

Objectives: To evaluate Parkinson's disease (PD)-associated pain as perceived by the patients (subjective characterization), and how this may change following initiation of rotigotine transdermal patch. Methods: SP1058 was a non-interventional study conducted in routine clinical practice in Germany and Austria in patients experiencing PD-associated pain (per the physician's assessment). Data were collected at baseline (ie, before rotigotine initiation) and at a routine visit after >= 25 days (-3 days allowed) of treatment on a maintenance dose of rotigotine (end of study [EoS]). Pain perception was assessed using the 12-item Pain Description List of the validated German Pain Questionnaire (each item ranked 0 = 'not true' to 3 = 'very true'). Primary effectiveness variable: change from baseline to EoS in the sum score of the 4 'affective dimension' items of the Pain Description List. Secondary effectiveness variables: change from baseline to EoS in Unified Parkinson's Disease Rating Scale (UPDRS) II, III, and II+III scores, and Parkinson's Disease Questionnaire (PDQ-8) total score (PD-related quality-of-life). Other variables included scores of the eight 'sensory dimension' items of the Pain Description List. Results: Of 93 enrolled patients (mean [SD] age: 71.1 [9.0] years; male: 48 [52%]), 77 (83%) completed the study, and 70 comprised the full analysis set. The mean (SD) change from baseline in the sum score of the four 'affective dimension' items was-1.3 (2.8) indicating a numerical improvement (baseline: 3.9 [3.4]). In the 'sensory dimension', pain was mostly perceived as 'pulling' at baseline (49/70 [70%]); ' largely true'/' very true'). Numerical improvements were observed in all UPDRS scores (mean [SD] change in UPDRS II+ III:-5.3 [10.5]; baseline: 36.0 [15.9]), and in PDQ-8 total score (-2.0 [4.8]; baseline: 10.7 [5.9]). Adverse drug reactions were consistent with dopaminergic stimulation and transdermal administration. Conclusion: The perception of the 'affective dimension' of PD-associated pain numerically improved in patients treated with rotigotine

A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in Parkinson’s patients with L-dopa induced dyskinesias

In this study, administrationof AQW051 did not show any efect on dyskinesias or artiparkinsonian effect. However, The results of cognition assessments for the PD population indicated that the study drug AQW051 wasnot associated with statistically significant benefits to any cognitive domain or individual cognitive function. However when the magnitude of change under drug was compared to that under placebo,moderate to large effects were observed for the Memory Composite scores and the tasks comprisingthe Memory Composite score (ONB and ISLT), which were also found significant in the Safetypopulation for 50 mg versus placebo for ISLT and the Memory Composite score. Psychiatric and sleep problems are observed in 30-40% of PD patients. Some of the study patients showed mild to moderate depression at baseline, and mild sleep abnormalities. However, there was no overall effect of AQW051 in regards of SCOPA, BDI and PDSS results during the study. Exposure to AQW051 in patients with Parkinson’s disease was as expected in an elderly population. In regard to safety, administration of AQW051 showed good tolerability as in previous AQW051 studies, and the majority of AEs were mild to moderate in severity. Seven AEs were reported to be severe in intensity of which 2 events were suspected to be related to study medication

Towards unambiguous reporting of complications related to deep brain stimulation surgery: A retrospective single-center analysis and systematic review of the literature

<div><p>Background and objective</p><p>To determine rates of adverse events (AEs) related to deep brain stimulation (DBS) surgery or implanted devices from a large series from a single institution. Sound comparisons with the literature require the definition of unambiguous categories, since there is no consensus on the reporting of such AEs.</p><p>Patients and methods</p><p>123 consecutive patients (median age 63 yrs; female 45.5%) treated with DBS in the subthalamic nucleus (78 patients), ventrolateral thalamus (24), internal pallidum (20), and centre médian-parafascicular nucleus (1) were analyzed retrospectively. Both mean and median follow-up time was 4.7 years (578 patient-years). AEs were assessed according to three unambiguous categories: (i) hemorrhages including other intracranial complications because these might lead to neurological deficits or death, (ii) infections and similar AEs necessitating the explantation of hardware components as this results in the interruption of DBS therapy, and (iii) lead revisions for various reasons since this involves an additional intracranial procedure. For a systematic review of the literature AE rates were calculated based on primary data presented in 103 publications. Heterogeneity between studies was assessed with the I² statistic and analyzed further by a random effects meta-regression. Publication bias was analyzed with funnel plots.</p><p>Results</p><p>Surgery- or hardware-related AEs (23) affected 18 of 123 patients (14.6%) and resolved without permanent sequelae in all instances. In 2 patients (1.6%), small hemorrhages in the striatum were associated with transient neurological deficits. In 4 patients (3.3%; 0.7% per patient-year) impulse generators were removed due to infection. In 2 patients electrodes were revised (1.6%; 0.3% per patient-year). There was no lead migration or surgical revision because of lead misplacement. Age was not statistically significant different (p>0.05) between patients affected by AEs or not. AE rates did not decline over time and similar incidences were found among all patients (423) implanted with DBS systems at our institution until December 2016. A systematic literature review revealed that exact AE rates could not be determined from many studies, which could not be attributed to study designs. Average rates for intracranial complications were 3.8% among studies (per-study analysis) and 3.4% for pooled analysis of patients from different studies (per-patient analysis). Annual hardware removal rates were 3.6 and 2.4% for per-study and per-patient analysis, respectively, and lead revision rates were 4.1 and 2.6%, respectively. There was significant heterogeneity between studies (I² ranged between 77% and 91% for the three categories; p< 0.0001). For hardware removal heterogeneity (I² = 87.4%) was reduced by taking study size (p< 0.0001) and publication year (p< 0.01) into account, although a significant degree of heterogeneity remained (I² = 80.0%; p< 0.0001). Based on comparisons with health care-related databases there appears to be publication bias with lower rates for hardware-related AEs in published patient cohorts.</p><p>Conclusions</p><p>The proposed categories are suited for an unequivocal assessment of AEs even in a retrospective manner and useful for benchmarking. AE rates in the present cohorts from our institution compare favorable with the literature.</p></div

Summary of adverse events.

<p>Summary of adverse events.</p

Sum of AEs defined by same severity, reversibility, and attribution to DBS therapy.

<p>Green, reversible; orange, non reversible; grey, unknown. The actual number of AEs is presented. The dotted area indicates AEs that were <i>severe</i> or worse and at least <i>possibly</i> related to DBS therapy and, thus, regarded the most critical. N.B. The number of affected patients may be less than the number indicated because individual patients may have suffered from more than one AE of respective groups (e.g. impairment of gait and speech rated as <i>mild</i>, <i>probably</i> related and <i>non-reversible</i>).</p