An Open-Label, Multicenter Observational Study for Patients with Alzheimer's Disease Treated with Memantine in the Clinical Practice

Background/Aims: In this post-marketing observational study, the safety and effectiveness of memantine were evaluated in patients with Alzheimer’s disease (AD). Methods: In a 6-month, observational, open-label study at 202 specialist sites in Greece, the effectiveness of memantine was evaluated using the Mini-Mental State Examination (MMSE) and the Instrumental Activities of Daily Living (IADL) scale at baseline, and after 3 and 6 months. Discontinuation rates and adverse drug reactions (ADRs) were also recorded to evaluate the safety profile of memantine. Results: 2,570 patients participated in the study. Three and 6 months after baseline, MMSE and IADL scores were significantly improved compared to baseline. At the end of the study, 67% of the patients had improved their MMSE score; 7.1% of the patients reported ≧1 ADRs, and treatment was discontinued due to ADR in 0.7%. Conclusion: Memantine was well tolerated and had a positive effect on the patient’s cognitive and functional ability in real-life clinical practice, in agreement with randomized, controlled trials

The impact of escitalopram on sleep problems of depressive patients in real-life clinical practice in greece

IntroductionThere is a bidirectional relationship between depression and insomnia, the latter being both a risk factor for the development of depression and a consequence of depression itself. Since depressive patients with residual symptoms of insomnia are at higher risk for disease recurrence, dealing successfully with sleep disorders during antidepressive treatment is of great importance.ObjectivesThe aim of the current study was to evaluate the effectiveness and tolerability of escitalopram on both depressive symptoms and sleep problems of depressive patients.MethodsAn observational, open-label, 3-month study was conducted in Greece.Effectiveness was assessed using the CGI-S and AIS (Athens Insomnia Scale) scales. Tolerability was evaluated by spontaneously reported adverse events and treatment discontinuation rates.ResultsThe study included 2,103 patients (mean age 51 ± 15 years, 64.0% women).Patients showed significant improvement during the treatment period for both depressive symptoms and sleep problems. Mean CGI-S scores decreased from 4.2 ± 0.8 to 2.2 ± 1.0 and total AIS score decreased from 13.6 ± 4.9 to 3.5 ± 3.8 (repeated measures analysis of variance Hotelling's test, p &lt; 0.001). The positive effect of escitalopram treatment was significant both on “night sleep” and “behaviour on the following days”. Moreover, the percentage of patients suffering from insomnia (AIS score &gt;=6) decreased from 89.1% to 22.1% (Cochran's Q test p &lt; 0.001). Escitalopram was also well tolerated, as 1909 (90.8%) patients successfully completed the study and 39 patients (1.85%) discontinued due to adverse events.ConclusionsEscitalopram combines significant effectiveness on both depressive symptoms and sleep problems with good tolerability.</jats:sec

Escitalopram in clinical practice in Greece: Treatment response and tolerability in depressed patients

Objective: To evaluate the effectiveness and tolerability of escitalopram (10-20 mg/day) in adult outpatients suffering from major depressive disorder in naturalistic settings. Methods: An open-label, 3-month, surveillance study was conducted in 434 investigative sites in Greece enrolling 5175 patients. Clinical Global Impression-Severity (CGI-S) scale and patient-rated Sheehan Disability Scale (SDS) were used as efficacy measurements and treatment discontinuation rates due to adverse events was used to assess tolerability. Results: Clinically significant improvement in CGI-S scores was recorded after 3 months. At baseline, patients reported marked or extreme disability for work (38%), social life (41%) and family life (37%), whereas after 3 months of treatment, 80.6%, 79.5% and 83.5% of patients indicated either no or mild disability, respectively. Escitalopram had good tolerability, demonstrated by a very low rate of discontinuations due to adverse events. Conclusion: In this large naturalistic study, escitalopram was well tolerated and improved both depressive symptoms and function. © 2009 Informa UK Ltd All rights reserved

Piloting the NPF data-driven quality improvement initiative.

OBJECTIVE: To pilot a data-driven quality care program in National Parkinson Foundation (NPF) Centers of Excellence. BACKGROUND: Evidence from comparative effectiveness research (CER) can be used to guide decisions regarding health care and to improve quality and efficiency of care. We propose to develop the infrastructure required to conduct CER across an extensive network of NPF Centers of Excellence. METHODS: We present the staged planning for a pilot study which will demonstrate the development and implementation of the infrastructure that will be needed for a large standardized patient-centered, clinical practice database for PD. This database will support CER and drive quality improvement studies. RESULTS: We describe the infrastructure for the ongoing pilot feasibility testing in a subset of six NPF Centers of Excellence, and we discuss the impact that the data (available in 2010) could have in guiding PD management. CONCLUSION: This preliminary experience will facilitate the longitudinal tracking of therapies and of outcomes in PD clinical practice. Further, we are hopeful that the information will provide insight into PD that will extend beyond the clinical trials population (the population included in most available PD databases). This prospective standardized real-world multi-center clinical practice database will aim to identify positive health outcomes associated with treatment approaches, and to identify variations in clinical outcomes that may suggest improvements in best clinical practice patterns

Management of the hospitalized patient with Parkinson's disease: current state of the field and need for guidelines

OBJECTIVE: To review the literature and to identify practice gaps in the management of the hospitalized Parkinson's disease (PD) patient. BACKGROUND: Patients with PD are admitted to hospitals at higher rates, and frequently have longer hospital stays than the general population. Little is known about outpatient interventions that might reduce the need for hospitalization and also reduce hospital-related complications. METHODS: A literature review was performed on PubMed about hospitalization and PD between 1970 and 2010. In addition, in press peer-reviewed papers or published abstracts known to the authors were included. Information was reviewed by a National Parkinson Foundation workgroup and a narrative review article was generated. RESULTS: Motor disturbances in PD are believed to be a causal factor in the higher rates of admissions and complications. However, other conditions are commonly recorded as the primary reason for hospitalization including motor complications, reduced mobility, lack of compliance, inappropriate use of neuroleptics, falls, fractures, pneumonia, and other important medical problems. There are many relevant issues related to hospitalization in PD. Medications, dosages and specific dosage schedules are critical. Staff training regarding medications and medication management may help to avoid complications, particularly those related to reduced mobility, and aspiration pneumonia. Treatment of infections and a return to early mobility is also critical to management. CONCLUSIONS: Educational programs, recommendations, and guidelines are needed to better train interdisciplinary teams in the management of the PD patient. These initiatives have the potential for both cost savings and improved outcomes from a preventative and a hospital management standpoint

Recent advances in psychoneuroimmunology: inflammation in psychiatric disorders

Psychiatric disorders are common and complex and their precise biological underpinnings remain elusive. Multiple epidemiological, molecular, genetic and gene expression studies suggest that immune system dysfunction may contribute to the risk for developing psychiatric disorders including schizophrenia, bipolar disorder, and major depressive disorder. However, the precise mechanisms by which inflammation-related events confer such risk are unclear. In this review, we examine the peripheral and central evidence for inflammation in psychiatric disorders and the potential molecular mechanisms implicated including inhibition of neurogenesis, apoptosis, the HPA-axis, the role of brain-derived neurotrophic factor and the interplay between the glutamatergic, dopaminergic and serotonergic neurotransmitter systems