Buflomedil for intermittent claudication

Background : Intermittent claudication (IC) is pain caused by chronic occlusive arterial disease, that develops in a limb during exercise and is relieved with rest. Buflomedil is a vasoactive agent used to treat peripheral vascular disease. However, its clinical efficacy for IC has not yet been critically examined. This is an update of a Cochrane review first published in 2000, and previously updated in 2007 and 2008. Objectives : To evaluate the available evidence on the efficacy of buflomedil for IC. Search methods : For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched January 2013) and CENTRAL (2012, Issue 12). Selection criteria : Double-blinded, randomized controlled trials (RCTs) in patients with IC (Fontaine stage II) receiving oral buflomedil compared with placebo. Pain-free walking distance (PFWD) and maximum walking distance (MWD) were analysed by standardized exercise test. Data collection and analysis : Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information. Main results : We included two RCTs with 127 participants. Both RCTs showed moderate improvements in PFWD for patients on buflomedil. This improvement was statistically significant for both trials (WMD 75.1 m, 95% confidence interval (CI) 20.6 to 129.6; WMD 80.6 m, 95% CI 3.0 to 158.2), the latter being a wholly diabetic population. For both RCTs, MWD gains were statistically significant with wide confidence intervals (WMD 80.7 m, 95% CI 9.4 to 152; WMD 171.4 m, 95% CI 51.3 to 291.5), respectively. Authors' conclusions : There is little evidence available to evaluate the efficacy of buflomedil for IC. Most trials were excluded due to poor quality. The two included trials showed moderately positive results; these are undermined by publication bias since we know of at least another four unpublished, irretrievable, and inconclusive studies. Buflomedil's benefit is small in relation to safety issues and its narrow therapeutic range

Indicators of prescribing quality in drug utilisation research: report of a European meeting (DURQUIM, 13-15 May 2004)

An invitational expert meeting on indicators of prescribing quality was held on 13-15 May 2004, bringing together-from 19 European countries, the US, Canada, and Australia-40 researchers specialized in the development and application of indicators. The meeting was organized by the European Drug Utilization Research Group (EuroDURG), the Belgian National Health Insurance Institute (RIZIV-INAMI), and the World Health Organisation Regional Office for Europe (WHO-Euro). The field of prescribing quality was defined and delineated from the medical error field. A conceptual grid for classifying quality indicators was discussed, combining two axes (a drug/disease/patient axis and a structure/process/outcome axis). In addition, available databases were listed for continuous monitoring of drug utilization in Europe, with a description of the content and the richness of the collected data, as well as the impact on the potential and limitations to develop quality indicators. The importance of the origin of data for validity assessment was stressed, as data on drug utilization may originate from physician sources (prescribing data), from pharmacist or health insurer sources (distribution data), or directly from patient sources (compliance data). The different aspects of validity and their methods of assessment were listed. An overview of the (in)appropriate uses of indicators was given. The state of the art of the development and application of prescribing quality indicators in all represented countries was made, together with a first draft of a database of prescribing quality indicators, already subjected to validation procedures

Living room vs concert hall patterns of music consumption in flanders

In this article we probe the interplay between public and private music consumption using a large-scale survey of the Flemish population in Belgium. We analyze whether public and private music consumption have different correlates and to what extent there is convergence between the genres that people listen to at home and at concerts. Results show that music consumption is positively related to all indicators of cultural capital-educational attainment, enrolment in arts classes and public participation of the parents. The effects are strongest for high-brow genres such as classical and opera and diminish for middle-brow and low-brow genres such as world/traditional music or pop/rock. Cultural capital is more important for public participation than for private consumption. This suggests that not only information processing capacity is involved when attending concerts, but also social barriers such as familiarity with the rules of decorum and network homophily. Omnivorousness in music consumption is especially situated in the private sphere

Development of a complex intervention to support the initiation of advance care planning by general practitioners in patients at risk of deteriorating or dying: a phase 0-1 study

Background: Most patients with life-limiting illnesses are treated and cared for over a long period of time in primary care and guidelines suggest that ACP discussions should be initiated in primary care. However, a practical model to implement ACP in general practice is lacking. Therefore, the objective of this study is to develop an intervention to support the initiation of ACP in general practice. Methods: We conducted a Phase 0-I study according to the Medical Research Council (MRC) Framework. Phase 0 consisted of a systematic literature review about the barriers and facilitators for GPs to engage in ACP, focus groups with GPs were held about their experiences, attitudes and concerns regarding initiating ACP in general practice and a review of ACP interventions to identify potential components for the development of our intervention. In Phase 1, we developed a complex intervention to support the initiation of ACP in general practice in patients at risk of deteriorating or dying, based on the results of Phase 0. The complex intervention and its components were reviewed and refined by two expert panels. Results: Phase 0 resulted in the identification of the factors inhibiting or enabling GPs' initiation of ACP and important components underpinning existing ACP interventions. Based on these findings, an intervention was developed in Phase 1 consisting of: (1) a training for GPs in initiating and conducting ACP discussions, (2) a register of patients eligible for ACP discussions, (3) an educational booklet on ACP for patients to prepare the ACP discussions that includes general information on ACP, a section on the role of GPs in the process of ACP and a prompt list, (4) a conversation guide to support GPs in the ACP discussions and (5) a structured documentation template to record the outcomes of discussions. Conclusion: Taking into account the barriers and facilitators for GPs to initiate ACP as well as the key factors underpinning successful ACP intervention in other health care settings, a complex intervention for general practice was developed, after gaining feedback from two expert panels. The feasibility and acceptability of the intervention will subsequently be tested in a Phase II study

Geneesmiddelengebruik in RVT's

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Impact of written drug information in patient package inserts: Acceptance and impact on benefit/risk perception

This thesis discusses the patient package insert (PPI), a folded sheet of paper in the drug package with a text which is supposed to be comprehensible for the general public. The PPI contains information on how the drug must be taken, on the risks of taking the drug, and a limited amount of information on whatthe drug is for. Belgium was the first country in Europe, together with Switzerland, to introduce PPIs. PPIs were first introduced in 1988 and the process was completed in 1992. In Europe, health authorities decided in 1992 that all medicinal product packages should contain a comprehensible insert. This decision is slowly but surely being implemented in all European countries. Similar developments did not take place in the US and other parts of the world, where medicines are distributed in bulk and dispensed without much information, even when dealing with powerful prescription drugs. During the introduction of PPIs in Belgium, a research programme wasconducted to evaluate this change in the way drug information was provided in the drug distribution system. This thesis provides an overview of the studiescarried out during that period. In addition, a number of other descriptive studies of the flow of drug information in specific patients groups is provided. Finally, a number of experimental studies is presented, which evaluate the impact of written drug information on patients? benefit/risk perception. The acceptance of a drug distribution system with mandatory PPIs in all drug packages will be evaluated on the basis of Belgium?s relatively long and welldocumented experience with PPIs. We address the following questions: what is the percentage of patients who read, accept and appreciate PPIs; what happens when a country changes from technical inserts with difficult jargon to comprehensible PPIs; what do we know about the impact of PPIs on patients knowledge and feelings about their drugs? In this thesis, an attempt is made to understand the mental processing of drug information which precedes patients' decisions and coping strategies, necessary for successful drug treatment. The question here is whether the PPI is capable of influencing the benefit/risk perception of patients. A further step is to study the impact of the PPI on behaviour. Here, other questions are at stake. Does the PPI have an impact on patients' reporting of health problems and side-effects, on their ability to carry out a treatment correctly and safely, on their adherence to therapy at the beginning of treatment, and on their motivation to continue crucial therapy? These questions are addressed only to a limited extent in this work, as we have focused on the preceding cognitive process of benefit/risk perception

Silence of the limbs: pharmacological symptomatic treatment of intermittent claudication

Several oral "vasoactive" drugs claim to increase walking capacity in patients with intermittent claudication (IC). Naftidrofuryl, cilostazol, buflomedil, and pentoxifylline are the most studied molecules. Although spanning several decades, several studies underlying these claims were not properly designed, underpowered or showed clinically doubtful outcomes. The evidence for these "vasoactive" drugs has always been received with scepticism, creating the need for systematic reviews and meta-analyses. This brief review discusses the benefit-risk assessment of vasoactive drugs, by applying a systematic review to evaluate randomized, placebo-controlled trials. Oral naftidrofuryl and cilostazol have an acceptable safety profile as well as sustained evidence (documented by Cochrane analyses) of increased walking capacity. Subsequently, these drugs entered recommendations for peripheral arterial disease (PAD). In contrast, buflomedil and pentoxifylline have limited and/or doubtful evidence to increase walking capacity. Moreover, there were safety concerns about the narrow therapeutic range of buflomedil. Most other "vasoactive" drugs were either inappropriately or insufficiently tested or showed no significant if not negative effects on IC. "Vasoactive" drugs are no substitutes for lifestyle or exercise therapy but are adjuvant treatment to the well-appreciated triad of cardiovascular prevention (antiplatelet agents, statins and ACE-inhibitors), of which statins in their own right have documented claims to significantly increase walking capacity. "Vasoactive" drugs may have a place in the pharmacological management of symptomatic PAD in addition to the basic cardiovascular pharmacotherapy, when revascularization is not indicated, when exercise therapy is not feasible or when there is still insufficient benefit