9,404,450 research outputs found
A new approach to psychiatric drug approval in Europe.
No full textCorrado Barbui and Irene Bighelli question the current rules governing registration of new medicines in Europe, using the example of psychiatric drugs, and argue that the concept of absolute efficacy should be replaced by the concept of added value whereby evidence from studies comparing a new product with an active comparator should guide the drug approval process. Please see later in the article for the Editors' Summary
Reply to the Comments by Doherty et al
No full textReply to: Doherty T, Daly EJ, Miller J, Popova V, Cepeda MS, Drevets WC, et al. Comments to Drs. Gastaldon, Raschi, Kane, Barbui, and Schoretsanitis. Psychother Psychosom. DOI: 10.1159/000512311. Referred to: Gastaldon C, Raschi E, Kane JM, Barbui C, Schoretsanitis G. Post-marketing safety con-cerns with esketamine: a disproportionality analysis of spontaneous reports submitted to the FDA Adverse Event Reporting System. Psy-chother Psychosom. DOI: 10.1159/000510703
Revisioni sistematiche e decisioni cliniche in psichiatria
No full textIn psichiatria, ormai da alcuni anni, accanto alle revisioni classiche della letteratura, le cosiddette revisioni narrative, gli articoli cioè in cui gli esperti di ciascun settore passano in rassegna le conoscenze riguardanti un determinato argomento per trarne conclusioni utili alia pratica clinica, si è progressivamente affermato un nuovo tipo di rassegna della letteratura, denominato revisione sistematica. Questo è avvenuto a seguito dell'altrettanto forte affermazione dell'idea secondo cui le decisioni in medicina devono basarsi sulle evidenze scientifiche a nostra disposizione. Le evidenze scientifiche sono meglio dette prove di efficacia, e il termine che descrive questo movimento è medicina basata sulle prove di efficacia (Barbui et al, 2002). Secondo il paradigma della medicina basata sulle prove di efficacia (o evidence-based medicine, da cui la sigla EBM) le revisioni sistematiche rappresentano lo strumento piu idoneo per riassumere le prove di efficacia esistenti per ogni argomento. Scopo di questo editoriale è chiarire che cosa sono le prove di efficacia in medicina ed esemplificare come queste ultime vengono correntemente utilizzate nella preparazione e nel mantenimento delle revisioni sistematiche. Obiettivo ultimo è discutere il possibile ruolo delle revisioni sistematiche nel supportare il processo di acquisizione di competenze che permettano di prendere decisioni in ambito psichiatrico.</jats:p
Leukocytosis and thrombosis in polycythemia vera: can clinical trials settle the debate?
No full textPotential to enhance the prescribing of generic drugs in patients with mental health problems in Austria; implications for the future
No full textScrutiny over pharmaceutical expenditure is increasing leading to multiple reforms. This includes Austria with measures to lower generic prices and enhance their utilization. However the situation for newer antidepressants and atypical antipsychotic medicines (AAPs) is different to PPIs, statins, and renin-angiotensin inhibitor drugs with greater tailoring of therapy and no wish to switch products in stable patients. Authorities welcome generics though given the high costs particularly of single-sourced AAPs. Assess (a) changes in utilization of venlafaxine versus other newer antidepressants before and after availability of generics, (b) utilization of generic versus originator venlafaxine, (c) price reductions of venlafaxine over time and their influence on total expenditure, (d) utilization of risperidone versus other AAPs, (e) suggest potential additional reforms that could be introduced if pertinent to further enhance the use of generics. A quasi-experimental study design with a segmented time series and an observational study. Utilization measured in defined daily doses (DDDs) and total expenditure per DDD and over time. No appreciable changes in the utilization of venlafaxine and risperidone after generics. The reduction in expenditure/DDD for venlafaxine decreased overall expenditure on newer antidepressants by 5% by the end of the study versus just before generics despite a 37% increase in utilization. Expenditure will further decrease if reduced prescribing of duloxetine. Depression, schizophrenia, and bipolar diseases are complex diseases. As a result, specific measures are needed to encourage the prescribing of generic risperidone and venlafaxine when multiple choices are appropriate. Authorities cannot rely on a "Hawthorne" effect between classes to enhance the use of generics. Measures may include prescribing restrictions for duloxetine. No specific measures planned for AAPs with more multiple-sourced AAPs becoming availabl
Abdomen wall structure of &lt;i&gt;Holocryptocanium barbui&lt;/i&gt; (Radiolaria)
No full textAbstract. The abdomen wall structure of the cryptothoracic Nassellaria Holocryptocanium barbui Dumitricǎ was studied using scanning electron microscopy. The abdomen wall consists of four layers, all of which have been observed as the ‘outer’ layer of specimens depending upon the different level of preservation. These different stages of abdominal wall preservation have been described previously as two separate subspecies of Holocryptocanium barbui.
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