The Social Value of Improvement in Activities of Daily Living among the Advanced Parkinson's Disease Population.

OBJECTIVES: Quantify the value of functional status (FS) improvements consistent in magnitude with improvements due to levodopa-carbidopa intestinal gel (LCIG) treatment, among the advanced Parkinson's disease (APD) population. METHODS: The Health Economic Medical Innovation Simulation (THEMIS), a microsimulation that estimates future health conditions and medical spending, was used to quantify the health and cost burden of disability among the APD population, and the value of quality-adjusted life-years gained from FS improvement due to LCIG treatment compared to standard of care (SoC). A US-representative Parkinson's disease (PD)-comparable cohort was constructed in THEMIS based on observed PD patient characteristics in a nationally representative dataset. APD was defined from the literature and clinical expert input. The PD and APD cohorts were followed from 2010 over their remaining lifetimes. All individuals were ages 65 and over at the start of the simulation. To estimate the value of FS improvement due to LCIG treatment, decreases in activities of daily living (ADL) limitations caused by LCIG treatment were calculated using data from a randomized, controlled, double-blind, double-dummy clinical trial and applied to the APD population in THEMIS. RESULTS: Total burden of disability associated with APD was $17.7 billion (B). From clinical trial data, LCIG treatment versus SoC lowers the odds of difficulties in walking, dressing, and bathing by 76%, 42% and 39%, respectively. Among the APD population, these reductions generated $2.6B in value to patients and cost savings to payers. The added value was 15% of the burden of disability associated with APD and offsets 15% of the cost of LCIG treatment. CONCLUSIONS: FS improvements, consistent with improvements due to LCIG treatment, in the APD population created health benefits and reduced healthcare costs in the US.

Formulation of levodopa containing dry powder for nasal delivery applying the quality-by-design approach.

The aim of this work was to carry out preliminary experiments for preparation of levodopa (LEVO)-containing intranasal powder. The experiments were designed according to the Quality by Design (QbD) concept. Based on prior risk assessment, LEVO and chitosan (CH) or sodium hyaluronate (HA) as mucoadhesive matrix formers were co-milled using planetary ball mill to prepare microparticles as drug delivery systems. The rotation speed, the milling time and the drug-additive ratio were evaluated to be the most relevant milling factors - as a result of the initial risk assessment; which were set according to a factorial design. The effects of critical process parameters and excipients were investigated on the particle size and surface characteristics of products, and on the crystallinity, in vitro dissolution and permeability of LEVO. Milling in the presence of higher amount of HA resulted in smaller average particle size of powders (D50 = 13.068 µm) and higher initial dissolution and permeation of LEVO compared to CH-containing formulations (D50 = 21.667 µm).

Expert Consensus Group report on the use of apomorphine in the treatment of Parkinson's disease--Clinical practice recommendations.

Extensive published evidence supports the use of subcutaneously-administered apomorphine as an effective therapy for Parkinson's disease (PD) but to date no consensus recommendations have been available to guide healthcare professionals in the optimal application of apomorphine therapy in clinical practice. This document outlines best-practice recommendations for selecting appropriate candidates for apomorphine intermittent injection (the pen-injection formulation) or apomorphine continuous infusion (the pump formulation), for initiating patients onto therapy and for managing their ongoing treatment. Apomorphine is a suitable therapeutic option for PD patients who experience troublesome 'off' periods despite optimized treatment with oral PD medications. Due to its speed of onset, apomorphine injection is particularly suited to those patients requiring rapid, reliable relief of both unpredictable and predictable 'off' periods, those who require reliable and fast relief when anticipating an 'off', those with levodopa absorption or gastric emptying problems resulting in delayed or failed 'on', or for rapid relief of early morning dystonia or akinesia. Apomorphine infusion(1) is suited for patients whose 'off' periods can no longer be adequately controlled by standard oral PD treatment or for those in whom rescue doses of apomorphine injection are effective but either needed too frequently (more than 4-6 times per day), or are associated with increasing dyskinesia. In addition to treating motor fluctuations, there is evidence that apomorphine infusion may be effective for the management of specific non-motor symptoms of PD associated with 'off' periods. Apomorphine infusion is less invasive than other non-oral treatment options for advancing disease, intrajejunal levodopa infusion and deep-brain stimulation.

Impact of community pharmaceutical care on patient health and quality of drug treatment in Parkinson's disease.

BACKGROUND: The well-being of patients with Parkinson's disease may be improved by pharmaceutical care in community pharmacies. OBJECTIVE: To investigate the effects of standardised pharmaceutical care on health outcomes and quality of drug treatment in patients with Parkinson's disease. SETTING: Community pharmacies in Germany. METHOD: An open-label, multicentre, longitudinal, parallel-group study was conducted in outpatients with idiopathic Parkinson's disease who were receiving anti-parkinsonian medication. Patients were recruited by 32 community pharmacists (pharmacy group) and local offices of the German Parkinson's disease patients' association (comparison group). All patients were assessed at baseline and at 8 months' follow-up. In the intervening period, the pharmacists provided patients in the pharmacy group with standardised pharmaceutical care. MAIN OUTCOME MEASURE: Mean change in symptom-related impairment of health status, assessed using the 23-item Parkinson's Scale Total Score. RESULTS: In total 235 patients were enrolled into the study (113 pharmacy group; 122 comparison group). Between-group analysis showed that the mean changes in the primary and secondary endpoints, all 23-item Parkinson's Scale sub-scores and the EuroQol 5-Dimension Questionnaire Index Score were significantly in favour of the pharmacy group after 8 months (p < 0.05 to p < 0.001), using a mixed model analysis. No significant changes were observed in prescribers' guideline adherence, but there was a significant decrease in the proportion of patients receiving inappropriate drugs according to the Beers List in the pharmacy group (p < 0.01). CONCLUSION: This study shows that significant benefits in patient health outcomes and age-related quality of drug treatment were gained when patients with Parkinson's disease were provided with standardised pharmaceutical care in community pharmacies.

Eficácia da memantina na doença de Alzheimer em seus estágios moderado a grave / Efficacy of memantine in moderate to severe Alzheimer disease

Introdução: o objetivo desta revisão de literatura é avaliar a eficácia, a segurança e a tolerabilidade da memantina, um antagonista não-competitivo do receptor N-metil-D-aspartato (NMDA), no tratamento da doença de Alzheimer em seus estágios moderado a grave. Métodos: realizou uma busca no banco de dados MEDLINE com as palavras-chave memantine e Alzheimer's disease, sendo inseridos apenas ensaios clínicos randomizados, duplo-cego e controlados com placebo. Resultados: foram incluídos quatro estudos que preenchiam os critérios de inclusão supracitados, realizados com pacientes portadores da doença Alzheimer com grau moderado a grave. Todos os estudos indicaram um efeito benéfico da memantina com relação ao placebo para os seguintes parâmetros: melhora da capacidade funcional e maior participação nas atividades diárias. Dois estudos evidenciaram melhora cognitiva. A duração média dos estudos foi de 28 semanas e as doses mais eficazes variaram de 10 a 20mg/dia. Os efeitos adversos, em todos os estudos, foram maiores no grupo placebo. Discussão: apesar de ser uma droga nova e ainda de custo elevado, a memantina parece reduzir os custos totais e o tempo gasto do cuidador, além de produzir melhora global do paciente, gerando melhor qualidade de vida tanto para o paciente quanto para o cuidador. Estudos ainda não publicados, contudo, sugerem que o impacto dessa droga nos estágios mais avançados da demência de Alzheimer seja marginal.