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Pani L.,Italian Medicines Agency AIFA | Pecorelli S.,Italian Medicines Agency AIFA | Rosano G.,Italian Medicines Agency AIFA | Rosano G.,St Georges, University of London | And 6 more authors.
European Journal of Heart Failure | Year: 2015

A workshop was organized by the Agenzia Italiana del Farmaco (AIFA) to discuss unmet needs and ways forward in the development of medicines in heart failure, their rationale, and cost-effective use. An integrated, multidisciplinary approach, including patients' needs and perspectives, was advocated by all the participants as the way to the most effective treatment regimens. More work is needed for reaching consensus on clinical and functional endpoints, for validating patient reported outcomes and measurements of well-being. Similarly, the integration into the clinical programmes of the health technology assessment/payers perspective, in particular, the evaluation of 'real-life' treatment effectiveness and of health as a value, would help in shifting the development and authorization of medicines from the molecule paradigm to their evaluation in the context of the whole health care regimen. Through this kind of workshop, AIFA is trying to build a template for meetings devoted to debate unmet needs with all stakeholders towards tentative road maps for the future. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology. Source


Bolignano D.,CNR Institute of Clinical Physiology | Cabassi A.,Cardiorenal Research Unit | Fiaccadori E.,University of Parma | Ghigo E.,University of Turin | And 7 more authors.
Clinical Chemistry and Laboratory Medicine | Year: 2014

Arginine vasopressin (AVP) plays a key role in many physiologic and pathologic processes. The most important stimulus for AVP release is a change in plasma osmolality. AVP is also involved in the response and adaptation to stress. Reliable measurement of AVP is hindered by several factors. Over 90% of AVP is tightly bound to platelets, and its estimation is influenced by the number of platelets, incomplete removal of platelets or pre-analytical processing steps. Copeptin (CTproAVP), a 39-aminoacid glycopeptide, is a C-terminal part of the precursor pre-provasopressin (pre-proAVP). Activation of the AVP system stimulates CTproAVP secretion into the circulation from the posterior pituitary gland in equimolar amounts with AVP. Therefore CTproAVP directly reflects AVP concentration and can be used as a surrogate biomarker of AVP secretion. In many studies CTproAVP represents AVP levels and its behavior represents changes in plasma osmolality, stress and various disease states, and shows some of the various physiologic and pathophysiologic conditions associated with increased or decreased AVP. Increased CTproAVP concentration is described in several studies as a strong predictor of mortality in patients with chronic heart failure and acute heart failure. Autosomal polycystic kidney disease (ADPKD) patients have both central and nephrogenic defects in osmoregulation and CTproAVP balance. A possibility raised by these clinical observations is that CTproAVP may serve to identify patients who could benefit from an intervention aimed at countering AVP. Source


Peracino A.,Fondazione Giovanni Lorenzini Medical Science Foundation
Audiology and Neurotology | Year: 2014

For some years, policy makers and medical scientists have both begun to focus more on chronic noncommunicable diseases. It is well known that cardio-cerebrovascular disease, tumors, diabetes, and chronic obstructive pulmonary disease (COPD), are considered areas of major interest in many scientific projects and health programs. The economic impact of cardio-cerebrovascular disease in EU alone is more than EUR 200 billion, while tumors have an impact of EUR 150 billion. The direct and indirect cost of brain disorders exceeds EUR 700 billion a year. Among the brain disorders, the devastating impact of dementia on affected individuals and the burden imposed on their families and society has made prevention and treatment of dementia a public health priority. Interventions that could merely delay the onset of dementia by 1 year would result in a more than 10% decrease in the global prevalence of dementia in 2050. Unfortunately, there are no known interventions that currently have such effectiveness. The manifestations of age-related hearing loss in many older adults are subtle and, thus, hearing loss is often perceived as an unfortunate but inconsequential part of aging. Researchers report that hearing loss seems to speed up age-related cognitive decline. Researchers suggest that treating hearing loss more aggressively could help delay cognitive decline and dementia. Furthermore, there is an increasing interest in better understanding the pathophysiologic correlations between hearing loss and dementia. Hearing loss in older adults, in fact, is associated independently with poorer cognitive functioning, incident dementia, and falls. Further research investigating the basis of this connection as well as the pathomechanism of the two diseases will further our ability to treat dementia. © 2015 S. Karger AG, Basel. Source


Bernabei R.,Catholic University of the Sacred Heart | Bonuccelli U.,University of Pisa | Maggi S.,CNR Institute of Neuroscience | Marengoni A.,European Union | And 7 more authors.
Aging Clinical and Experimental Research | Year: 2014

The association between hearing impairment, the diagnosis of dementia, and the role of sensory therapy has been proposed for some time, but further research is needed. Current understanding of this association requires the commitment of those experts who can integrate experience and research from several fields to be able to understand the link from hearing to dementia. A workshop whose panelists included experts from many areas, ranging from ear, nose and throat (ENT) to dementia’s specialists, was promoted and organized by the Giovanni Lorenzini Medical Science Foundation (Milan, Italy; Houston, TX, USA) to increase the awareness of the relationship between hearing loss and dementia, and included questions and comments following a presentation from the clinical researcher, Frank Lin, who has been evaluating the relationship between hearing loss and cognitive decline since 2009. Source


Plebani M.,University of Padua | Di Somma S.,Medicina dUrgenza e Pronto Soccorso | Monzani V.,U.O. Medicina dUrgenza e Pronto Soccorso | Tubaro M.,ICCU | And 10 more authors.
Clinical Chemistry and Laboratory Medicine | Year: 2012

The evaluation of patients admitted at the emergency department (ED) for chest pain is challenging and involves many different clinical specialists including emergency physicians, laboratory professionals and cardiologists. The preferable approach to deal with this issue is to develop joint protocols that will assist the clinical decision-making to quickly and accurately rule-out patients with non life-threatening conditions that can be considered for early and safe discharge or further outpatient follow-up, rule-in patients with acute coronary syndrome and raise the degree of alert of the emergency physicians on non-cardiac life-threatening emergencies. The introduction of novel biomarkers alongside the well-established troponins might support this process and also provide prognostic information about acute short-term or chronic long-term risk and severity. Among the various biomarkers, copeptin measurement holds appealing perspectives. The utility of combining troponin with copeptin might be cost-effective due to the high negative predictive value of the latter biomarker in the rule-out of an acute coronary syndrome. Moreover, in the presence of a remarkably increased concentration (e.g., more than 10 times the upper limit of the reference range), to reveal the presence of acute life-threatening conditions that may not necessarily be identified with the use of troponin alone. The aim of this article is to review current evidence about the clinical significance of copeptin testing in the ED as well as its appropriate placing within diagnostic protocols. © 2012 by Walter de Gruyter Berlin Boston. Source

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