Efficacy and safety of eslicarbazepine acetate as add‐on treatment in patients with focal‐onset seizures: Integrated analysis of pooled data from double‐blind phase III clinical studies

Purpose:  To evaluate the efficacy and safety profile of eslicarbazepine acetate (ESL) added to stable antiepileptic therapy in adults with partial‐onset seizures. Methods:  Data from 1,049 patients enrolled from 125 centers, in 23 countries, in three phase III double‐blind, randomized, placebo‐controlled studies were pooled and analyzed. Following a 2‐week titration period, ESL was administered at 400 mg, 800 mg, and 1,200 mg once‐daily doses for 12 weeks. Key Findings:  Seizure frequency was significantly reduced with ESL 800 mg (p < 0.0001) and 1,200 mg (p < 0.0001) compared to placebo. Median relative reduction in seizure frequency was, respectively, 35% and 39% (placebo 15%) and responder rate was 36% and 44% (placebo 22%). ESL was more efficacious than placebo regardless of gender, geographic region, epilepsy duration, age at time of diagnosis, seizure type, and number and type of concomitant antiepileptic drugs (AEDs). Incidence of adverse events (AEs) and AEs leading to discontinuation were dose dependent. AEs occurred mainly during the first weeks of treatment, with no difference between groups after 6 weeks. Most common AEs (>10% patients) were dizziness, somnolence, and headache. The incidence of AEs in ESL groups compared to placebo was generally consistent among different subpopulations. Significance:  Once‐daily ESL 800 mg and 1,200 mg showed consistent results across all efficacy and safety end points. Results were independent of study population characteristics and type and number of concomitant AEDs.     

A simple measure with complex determinants: investigation of the correlates of self-rated health in older men and women from three continents

ABSTRACT: BACKGROUND: Self-rated health is commonly employed in research studies that seek to assess the health status of older individuals. Perceptions of health are, however, influenced by individual and societal level factors that may differ within and between countries. This study investigates levels of self-rated health (SRH) and correlates of SRH among older adults in Australia, United States of America (USA), Japan and South Korea. METHODS: Cross-sectional data were drawn from large surveys of older respondents ([greater than or equal to] 65 years) in Australia (n=7,355), USA (n=10,358), Japan (n=3,541) and South Korea (n=3,971), collected between 2000 and 2006. Harmonized variables were developed to represent socioeconomic, lifestyle and health indicators. We then assessed whether these variables, and their potentially different impact in different countries, could account for cross-national differences in levels of SRH. RESULTS: SRH differed significantly between countries, with older Koreans reporting much poorer health than those in the other three nations. This was not the result of biases in response patterns (for example central versus extreme tendency). Health-related correlates of SRH were similar across countries; those with more medical conditions, functional limitations or poor mental health gave poorer ratings. After accounting for the differential impact of determinants in different national contexts, Australians reported better SRH than other nations. CONCLUSIONS: We conclude that when examining correlates of SRH, the similarities are greater than the differences between countries. There are however differences in levels of SRH which are not fully accounted for by the health correlates. Broad generalizations about styles of responding are not helpful for understanding these differences, which appear to be country, and possibly cohort specific. When using SRH to characterize the health status of older people, it is important to consider earlier life experiences of cohorts as well as national and individual factors in later life. Further research is required to understand the complex societal influences on perceptions of health.     

Assessing patterns of home and community care service use and client profiles in Australia: a cluster analysis approach using linked data

The planning and delivery of care systems require knowledge on the ways in which individuals access available services that are funded by a range of health and community services. The aims of this study were to identify distinct groups of Home and Community Care (HACC) clients in New South Wales, Australia, based on patterns of actual service use, and to understand the health and social needs and resources of client groups that access different mixes of services. Multiple data sets linked at the individual level - including the 45 and Up Study community survey, the HACC Minimum Data Set and the Admitted Patient Data Collection for hospitals - provide an innovative basis to investigate the complexity of access to service use. Data were collected between 2006 and 2008. A cluster analysis based on clients' type and volume of community service use was conducted on the 4890 HACC clients in the linked dataset and nine distinct clusters of clients were identified. Three of these clusters were considered 'complex', in terms of the range of community and hospital assistance received, while the others comprised mainly of one or two dominant service types. The analytical approach and findings developed here provide a client-centred approach to monitor and evaluate access to local service systems that are being reformed to better integrate the delivery of health and community services currently funded and managed separately by national and state governments.     

Hospital transfer of patients with acute myocardial infarction: the effects of age,race, and insurance type

BACKGROUND: Many factors precipitate the transfer of patients hospitalized for acute myocardial infarction, including clinical status and the need for diagnostic testing and therapeutic interventions not available at the admitting hospital. The objectives of this study were to assess the frequency of transfer to another hospital and to determine whether nonmedical factors, such as age, sex, race, and insurance status, are associated with transfer. METHODS: We conducted a prospective study of patients with acute myocardial infarction who were enrolled in the National Registry of Myocardial Infarction 2 from June 1994 through March 1998. The Registry involves 1674 hospitals in the United States. All patients survived to the time of hospital discharge or until transfer. Multivariable logistic regression models, with transfer as the outcome variable, were developed for the entire sample, as well as for subgroups determined by the interventional capabilities of the admitting hospital. RESULTS: Of 537,283 patients with acute myocardial infarction, 152,310 (28%) were transferred to another hospital after admission. After adjustment for differences in clinical and hospital characteristics, factors that were most associated with a reduced odds of transfer included older age (odds ratio [OR] = 0.43; 95% confidence interval [CI]: 0.42 to 0.44 for those aged >75 vs. <65 years), African-American race (OR = 0.69; 95% CI: 0.67 to 0.71 for African Americans vs. whites), and Medicaid/self-pay insurance status (OR = 0.68; 95% CI: 0.66 to 0.70 for Medicaid/self-pay vs. commercial insurance). These effects were most apparent for patients admitted to hospitals without full invasive diagnostic and therapeutic capabilities, but persisted to some extent among those admitted to hospitals with full invasive services. CONCLUSION: Our findings suggest that nonmedical factors, including age, race, and insurance type, affect decisions regarding the transfer of patients hospitalized with acute myocardial infarction. As only a minority of the nation's hospitals offers a full range of cardiovascular diagnostic and therapeutic procedures, these findings reinforce ongoing concerns about disparities in access to health care services for some patients.