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Selected AbstractsPaliperidone palmitate , review of the efficacy, safety and cost of a new second-generation depot antipsychotic medicationINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 2 2010L. Citrome Summary Objective:, To describe the efficacy, safety and cost of paliperidone palmitate, a depot antipsychotic medication recently approved for the treatment of schizophrenia. Data sources:, A literature search was conducted by querying the websites http://www.pubmed.gov, http://www.fda.gov, http://www.accessdata.fda.gov/scripts/cder/drugsatfda and http://www.clinicaltrials.gov for the search term ,paliperidone palmitate'. Cost information was obtained from the pharmaceutical vendor servicing a local state-operated psychiatric facility. Study selection:, All available reports of studies were identified. Product labelling provided additional information. Data extraction:, Descriptions of the principal results and calculation of the number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the study reports and synopses. Additional safety outcomes subject to NNH analysis were obtained from product labelling. Data synthesis:, Paliperidone palmitate is a newly available depot formulation of paliperidone (the 9-OH metabolite of risperidone). Upon injection into the deltoid or gluteal muscle, the release of the drug starts as early as day 1, reaches maximum plasma concentrations at 13 days and lasts for as long as 126 days. Maximum concentration following deltoid injection is approximately 28% higher compared with injection into the gluteal muscle, and thus paliperidone palmitate requires initiation by two initial deltoid injections spread 1 week apart to achieve therapeutic concentrations rapidly. Subsequent injections are at 4-week intervals. Acute efficacy was evidenced by four short-term double-blind, randomised, placebo-controlled, fixed-dose studies of acutely relapsed adult inpatients who met DSM-IV criteria for schizophrenia. NNT for a 30% or greater decrease in the Positive and Negative Syndrome Scale total score compared with placebo was consistently lower for the higher dose strengths of 156 and 234 mg, suggesting a therapeutic dose,response. Treatment with paliperidone palmitate at doses between 39 and 156 mg significantly delayed the time to recurrence of symptoms of schizophrenia after 24 weeks of maintained symptom stability. The NNT vs. placebo to avoid a recurrence of symptoms was 5 (95% CI 4,7). Overall, paliperidone palmitate was reasonably well tolerated, with low rates of extrapyramidal symptoms or body weight gain; however, these may be more common at higher doses. Injection site reactions occurred at a rate ranging from 4% to 10%, depending on the dose regimen, compared with 2% for the pooled placebo arms. The acquisition cost of a maintenance dose of paliperidone palmitate calculated on a per day basis is similar to that for risperidone microspheres, but about double the cost for oral paliperidone and approximately 19 times the cost of oral generic risperidone. Conclusions:, Paliperidone palmitate is efficacious for the acute and maintenance treatment of schizophrenia and is reasonably well tolerated. It offers several advantages over other available second-generation depot antipsychotics: it comes in prefilled syringes in a number of different dosage strengths; it does not require refrigeration; it does not require supplementation with oral antipsychotics; it can be administered once monthly; it can be administered with a very small bore needle; the injection volume is small; the injection site can be either the deltoid or gluteal muscles; it does not require an additional precautionary observation period after the injection. For patients for whom oral risperidone or paliperidone is otherwise effective, paliperidone palmitate offers a guaranteed delivery system that enhances adherence. However, the high acquisition cost of paliperidone palmitate will likely be an important obstacle to its routine use. [source] Intra Day Bid-Ask Spreads, Trading Volume and Volatility: Recent Empirical Evidence from the London Stock ExchangeJOURNAL OF BUSINESS FINANCE & ACCOUNTING, Issue 5-6 2004Charlie X. Cai With the benefit of very high frequency (25 million 1 minute observations) and recent data (2001) for the UK, this paper explores a number of intra day patterns of stock market behaviour. More specifically, a distinct reverse J shaped bid-ask spread pattern is noted for SETS securities, a declining bid-ask spread pattern for non-SETS securities, a two hump pattern for trading volume and a U-shaped pattern for returns volatility for all securities. In terms of complementing the existing literature, the paper shows that differences in trading systems may affect the bid-ask spread patterns, while differences in market environments (i.e. US and UK markets) seems to affect the trading volume pattern. The paper suggests avenues for future research, in particular, the need to consider what factors are significant in determining intra day patterns for different trading systems and the need for additional cross-market comparisons to identify how institutional factors affect the behaviour of investors on an intra day basis. [source] Apheresis treatment of recurrent focal segmental glomerulosclerosis after kidney transplantation: Re-analysis of published case-reports and case-seriesJOURNAL OF CLINICAL APHERESIS, Issue 4 2001Robertson D. Davenport Abstract A systematic re-analysis of published cases was performed to better define the role of plasmapheresis in the treatment recurrent focal segmental glomerulosclerosis after renal transplantation. Forty-four cases were identified, of which 32 responded to apheresis. The median number of treatments to response was 9. There was no difference between responders and nonresponders in the total number of treatments performed. The presence of sclerosis on biopsy predicted treatment failure. Relapse after first successful treatment was reported in 10 cases. The median number of treatments received was less and the time from diagnosis to first treatment was greater for patients who relapsed than for patients in whom relapse was not reported, but the differences were not statistically significant. On the basis of this analysis, we recommend early treatment after diagnosis with a regimen of three daily plasmapheresis treatments followed by 6 treatments on an every other day basis. J. Clin. Apheresis 16:175,178, 2001. © 2001 Wiley-Liss, Inc. [source] Music and its effect on anxiety in short waiting periods: a critical appraisalJOURNAL OF CLINICAL NURSING, Issue 2 2005Marie Cooke PhD Aims and objectives., This paper undertakes a critical appraisal of the methodological issues associated with studies that have investigated the extent to which music decreased the anxiety experienced by patients in short-term waiting periods such as day surgery. Background., Investigations and surgery undertaken on a day basis have significantly increased in number over the last decade. Music has been evaluated as an appropriate nursing intervention in relation to pain, discomfort and anxiety in a number of clinical settings but its usefulness for decreasing anxiety in short-term waiting periods such as day surgery is only beginning to be understood. Conclusion., A number of methodological limitations are identified by this critical review, particularly in relation to the design of research studies. Recommendations to strengthen research in this area are suggested and include (i) describing methods clearly and with detail to allow assessment of the validity and rigour of study results; (ii) using permuted block randomization; (iii) recruiting from a variety of surgical procedures and cultural groups; and (iv) standardizing the health care provided during waiting period. Relevance to clinical practice., Music as a simple and cost-effective intervention to reduce the anxiety experienced in limited time periods will have enormous impact on clinical practice where patients wait and undergo invasive investigations, procedures or surgery. However, the evidence of its utility in these unique environments is only beginning to emerge and this critical review provides a basis for considerations for future research. [source] Managing Discursive Tension: the Co,Existence of Individualist and Collaborative Discourses in Flight CentreJOURNAL OF MANAGEMENT STUDIES, Issue 8 2002Ian Palmer Our study of the travel agency Flight Centre began as a case study of a company that appears to be a ,success story' in what is a highly competitive industry. In the course of our study we found that inscribed in Flight Centre were two, differing discourses which appear to co,exist in creative tension throughout the organization. One discourse is competitive individualism and the other collaborative teamwork. Our paper focuses on how Flight Centre has made use of multiple discourses such as these in the process of achieving competitive advantage, and how people manage the differing discursive logics which confront them on a day,to,day basis. The paper proceeds by identifying the social and textual practices which constitute each discourse. It then establishes the discursive co,existence and tension which exists between the two discourses. Study is made of the conditions under which this discursive co,existence is disrupted. We then identify the interpretative routines and practices through which organizational actors maintain and reproduce discursive co,existence. Our paper concludes by considering a variety of implications of studying multiple discourses in organizations. [source] WHO/ISBRA Study on State and Trait Markers of Alcohol Use and Dependence: Analysis of Demographic, Behavioral, Physiologic, and Drinking Variables That Contribute to Dependence and Seeking TreatmentALCOHOLISM, Issue 7 2002Jason Glanz Background Discussions between the World Health Organization (WHO) and the International Society on Biomedical Research on Alcoholism (ISBRA) identified the need for a multiple-center international study on state and trait markers of alcohol abuse and alcohol dependence. The reasoning behind the generation of such a project included the need to understand the alcohol use characteristics of diverse populations and the performance of biological markers of alcohol use in a variety of settings throughout the world. A second major reason for initiating this study was to collect DNA for well-structured and stratified association studies between genetic markers and/or "candidate" genes and behavioral/physiological phenotypes of importance to predisposition to alcohol dependence. Methods An extensive interview instrument was developed with leadership from the U.S. National Institute on Alcohol Abuse and Alcoholism (NIAAA). The instrument was translated from English to Finnish, French, German, Japanese, and Portuguese (Brazilian). One thousand eight hundred sixty-three subjects were recruited at five clinical centers (Montreal, Canada; Helsinki, Finland; Sapporo, Japan; São Paulo, Brazil; and Sydney, Australia). The subjects responded to the structured interview and provided blood and urine samples for biochemical analysis. This article focuses on the demographic characteristics of the study subjects, their drinking habits, alcohol-dependence characteristics, comorbid psychiatric and other drug variables, and predictors for seeking treatment for alcohol dependence. Multiple logistic regression models were constructed and used to explore variables that contribute to various levels of alcohol consumption, to a diagnosis of alcohol dependence, and to seeking treatment for alcohol dependence. ANOVA with post hoc comparisons, ,2, and Pearson moment calculations were used as necessary to assess additional relationships between variables. Results A number of factors previously noted in disparate studies were confirmed in our analysis. Men consumed more alcohol than women, Asians consumed less alcohol than whites or Blacks, alcohol-dependent subjects consumed more alcohol than nondependent subjects, alcohol consumption increased with age, and an increased level of education (university or postgraduate education) reduced the percentage of such individuals in the category designated as heavy drinkers (>210 g alcohol/week) and in the group who were currently in treatment for dependence. However, our analysis allowed for much more detailed comparisons; for example, although men drank more than women on a g/day basis, the differences were less pronounced on g/kg/day basis, and alcohol-dependent women drank equal amounts of alcohol as alcohol-dependent men on a g/kg/day basis. Antisocial personality characteristics or reports of trouble sleeping when an individual stops drinking were associated with higher alcohol intake. The most important of the tested factors that contributed to a DSM-IV diagnosis of dependence, however, was the report of anxiety if an individual stopped drinking. In terms of the various criteria within the DSM-IV criteria for alcohol dependence, no one criterion seemed to be prominent for individuals who sought alcohol dependence treatment, but the higher the number of criteria met by the individual, the higher was the probability that he or she would be in treatment. Conclusions This initial report is the beginning of the "data mining" of this rich data set. The cross-national/cross-cultural aspects of this study allowed for multiple comparisons of variables across several ethnic/racial groups and allowed for assessment of biochemical markers for alcohol intake and predisposition to alcohol dependence in diverse settings. [source] | |||||||||||||