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Utilizzo di dronedarone, amiodarone e rischio di insufficienza renale acuta: uno studio di coorte sulla popolazione di Lombardia ed Emilia Romagna
Full text linkINTRODUCTION
Dronedarone is a multichannel blocker and it was approved in 2009 by the European Commission in the treatment of arrhythmias (atrial fibrillation, paroxysmal or persistent). Initially, it was assessed as a less efficacious but possibly safer anti-arrhythmic drug than amiodarone, but soon unfavourable safety issues were raised (doubling of cases of death in patients with severe heart failure and left ventricular systolic dysfunction, life-threatening cases of liver failure requiring liver transplantation, increased rate of heart failure, stroke and death from cardiovascular causes in patients with permanent atrial fibrillation and at risk for major cardiovascular events, reports of possible lung toxicity). In 2012, during the periodic assessment of reported adverse drug reactions in the Italian database, a possible association between dronedarone exposure and acute renal failure (ARF) occurrence was identified. To better investigate the potential association between renal damage and dronedarone, a retrospective cohort study using regional health service claim databases from Lombardy and Emilia Romagna was performed.
METHODS
From the outpatients drugs prescription database we extracted all patients receiving at least one prescription of amiodarone or dronedarone between 1st September 2010 and 31th December 2012. Each member of the cohort was followed from the first prescription until the earliest of the following events: first hospitalization for ARF (outcome of interest), discontinuation or switching from the election therapy, death of any cause, emigration and end of the follow-up (31th December 2012). We undertook Cox regression models to estimate the hazard ratios (HRs), with 95% confidence intervals (CIs) for the association between dronedarone and the risk of ARF, taking amiodarone group as baseline comparison. We estimated HRs adjusted for high-dimensional propensity score, taking the drug and diagnosis codes from large health care claims databases.
RESULTS
During the study period, 59,881 patients without previous episodes of renal failure, started a new treatment with dronedarone (1,751) or amiodarone (58,130), and generated 30 and 1831 events of ARF, respectively. The mean age of patients treated with dronedarone was significantly lower than that of amiodarone ones (70.1 vs. 74.8). About 50% of patients in dronedarone group were males compared with 56% of the amiodarone group. Patients on dronedarone group had typically less comorbidities than those starting with amiodarone. The risk of hospitalization for renal failure for dronedarone compared to amiodarone was 0.79 (IC 95% 0.47-1.33).
CONCLUSIONS
Our results revealed a lower risk of hospitalization for renal failure for dronedarone compared to amiodarone. Since the increasing number of reports collected from pharmacovigilance databases worldwide, it is advisable for clinicians and patients to be aware of the risk of kidney damage during dronedarone therapy. The safety information on renal toxicity provided on the labels of amiodarone-containing products marketed in different countries is not standardized, therefore harmonization would be helpful for the healthcare practitioner and patients.UTILIZZO DI DRONEDARONE, AMIODARONE E RISCHIO DI INSUFFICIENZA RENALE ACUTA: UNO STUDIO DI COORTE SULLA POPOLAZIONE DI LOMBARDIA ED EMILIA ROMAGNA
INTRODUZIONE
Il dronedarone è un bloccante multicanale approvato dalla Commissione europea nel 2009 per il trattamento di alcune forme di aritmia (fibrillazione atriale, parossistica o persistente).
A sostegno della sua autorizzazione al commercio, si dichiarava che il farmaco fosse un po’ meno efficace ma più sicuro dell’amiodarone, ma ben presto il farmaco è stato associato a gravi problemi di sicurezza (raddoppio dei decessi in pazienti con grave insufficienza cardiaca e disfunzione ventricolare sistolica sinistra, casi di insufficienza epatica con necessità di trapianto, di insufficienza cardiaca, ictus, decessi per cause cardiovascolari in pazienti con fibrillazione atriale permanente e a rischio di eventi cardiovascolari maggiori, casi di tossicità polmonare).
Nel 2012, alcuni dati derivanti dalla segnalazione spontanea in Italia avevano fatto emergere una associazione causale tra esposizione a dronedarone e insufficienza renale acuta (IRA).
Al fine di approfondire tale segnale, è stato eseguito uno studio di coorte utilizzando i database delle prescrizioni farmaceutiche e delle schede di dimissioni ospedaliere delle regioni Lombardia ed Emilia Romagna.
METODI
Sono stati selezionati i pazienti con una nuova prescrizione di amiodarone o di dronedarone nel periodo compreso tra il 1 settembre 2010 e il 31 dicembre 2012. Ogni paziente è stato seguito dalla prima prescrizione fino alla comparsa di uno dei seguenti eventi: primo episodio di ricovero per IRA (evento di interesse), morte per altra causa, emigrazione, interruzione o switching della terapia, fine del follow-up (31 dicembre 2012). Il rischio di IRA nei trattati con dronedarone rispetto a quelli con amiodarone è stato valutato tramite l’hazard ratio (HR) con intervallo di confidenza (IC) al 95%, stimato da un modello di regressione di Cox. Le stime sono state corrette utilizzando l’high dimensional propensity score, costruito utilizzando i database delle prescrizioni e dei ricoveri.
RISULTATI
Nel periodo di osservazione, sono stati reclutati 59.881 soggetti senza precedenti episodi di insufficienza renale, di cui 1.751 nuovi trattati con dronedarone e 58.130 con amiodarone, con 30 e 1831 eventi, rispettivamente. I trattati con dronedarone sono risultati più giovani (età media 70,1 vs. 74,8), di sesso femminile (50,1 % vs. 44%) e con meno comorbilità.
Il rischio di ricovero per IRA nei trattati con dronedarone rispetto al gruppo trattato con amiodarone è stato pari a 0,79 (IC 95% 0,47-1,33).
CONCLUSIONI
I nostri risultati hanno rivelato un minor rischio di ospedalizzazione per insufficienza renale da dronedarone rispetto all’amiodarone. Tuttavia, dato il crescente numero di segnalazioni di danno renale da dronedarone raccolte nelle banche dati di farmacovigilanza a livello mondiale, è consigliabile che i medici e i pazienti siano consapevoli di questa associazione.
Le informazioni di sicurezza sulla tossicità renale nelle schede tecniche dei medicinali contenenti amiodarone commercializzati in diversi paesi non sono standardizzate, e sarebbe quindi opportuno procedere a una armonizzazione nell’interesse di medici e pazienti
Going Beyond Counting First Authors in Author Co-citation Analysis
Full text linkThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Full text link“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Full text linkWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
Dispelling the Myths Behind First-author Citation Counts
Full text linkWe conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued
use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation
counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more
sophisticated methods
Signal detection activity on EudraVigilance data: analysis of the procedure and findings from an Italian Regional Centre for Pharmacovigilance
No full textBackground: In July 2012 a new European legislation (Directive 2010/84/EU and Regulation No. 1235/2010) regarding pharmacovigilance has become effective. It has boosted the activity of Signal Detection through a monthly analysis of potential safety signals on EudraVigilance (EV). Our aim is to describe the procedure of signal detection on EV data and to present results obtained by the our pharmacovigilance centre. Method: Data are extracted from EV database, which collects suspected Adverse Drug Reactions (ADRs) of medicinal products in Europe. We are appointed to supervise digoxin, nicardipine, delapril, manidipine and hydrochlorothiazide/ramipril. ADRs are coded through MedDRA Preferred Terms and collected in the electronic Reaction Monitoring Report (eRMR). Statistical analysis is based on the Proportional Reporting Ratio (PRR) as a measure of disproportionality. Results: Up to April 2016 we have analyzed 45 eRMR for each drug. Two signals for nicardipine were submitted to the Pharmacovigilance Risk Assessment Committee of European Medicines Agency (EMA): acute pulmonary oedema (off-label use as tocolytic) and thrombocytopenia. Conclusions: Our experience shows the scientific and regulatory value of signal detection activity on EV data in order to continuously evaluate the benefit/risk profile of recent and older drugs
Off-label use of nicardipine as tocolytic and acute pulmonary oedema: A post-marketing analysis of adverse drug reaction reports in EudraVigilance
No full textPurpose: To evaluate a signal of acute pulmonary oedema (APO) due to nicardipine used off-label as tocolytic in pregnant women. Methods: All the suspected cases of APO recorded in EudraVigilance database up to 31/01/2013 and associated with nicardipine containing medicinal products were retrieved. The Proportional Reporting Ratio was considered as measure of disproportionality. Individual cases evaluation was conducted. Results: Thirty-four spontaneous cases regarding pregnancy women who experienced APO following nicardipine treatment as tocolytic were collected. The detected proportional reporting ratio was 50.96 (95% confidence interval lower bound equal to 36.75). The analysis focused on 10 serious cases. Most women, aged between 27 and 39 years, were treated with intravenous nicardipine. The most of the suspected adverse reactions occurred between 24 and 96hours. Conclusions: A potentially causal association between APO and off-label use of nicardipine as tocolytic has been detected during a periodic signal detection activity. The Pharmacovigilance Risk Assessment Committee confirmed our findings, recommending an update of the summary of the product characteristics for medicines containing nicardipine for both intravenous and oral formulations. Then European Medicines Agency reaffirmed that nicardipine use in other indications is no longer recommended
koamabayili/VECTRON-author-checklist: VECTRON author checklist
No full textWe have done our best to complete the author checklist relating to the use of animals in the hut study. Note that the objective for the hut study was to evaluate the IRS treatment applications for residual efficacy against Anopheles mosquitoes, including the local An. coluzzii mosquito population. Cows were only used to attract mosquitoes into the huts and no tests were carried out directly on the cows. The author checklist is intended for use with studies where experiments are carried out on animals, which is why we have had such difficulty in completing this for the hut study, as many of the questions do not relate to how the cows were used
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