Progress or lack of progress in hospitalized heart failure

Vaduganathan, Muthiah; Butler, Javed; Fonarow, Gregg C.; Gheorghiade, Mihai

doi:10.1586/14779072.2013.827465

“…The current European Society of Cardiology (ESC) guidelines define HF as a complex syndrome, clinically characterized by signs and symptoms resulting from abnormality of the cardiac structure or function. Even though the wording varies slightly across articles and textbooks, the definition of HF remains a semeiotic and functional one, where ‘abnormal’ cardiac function is not a disease but the final common pathway of different conditions, among which the most common is ischaemic heart disease …”

Section: Introductionmentioning

confidence: 99%

Steps forward in regulatory pathways for acute and chronic heart failure

Pani

¹

,

Pecorelli

²

,

Rosano

³

et al. 2015

European J of Heart Fail

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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.

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“…Even though the wording varies slightly across articles and textbooks, the definition of HF remains a semeiotic and functional one, where 'abnormal' cardiac function is not a disease but the final common pathway of different conditions, among which the most common is ischaemic heart disease. 4 The heterogeneity of aetiology and clinical and functional manifestations has a significant impact on the development of treatments for acute and chronic HF. Comorbidities entwined in the pathophysiology of HF such as coronary artery disease/ischemia, diabetes mellitus, depression and other neurological diseases, renal dysfunction, anaemia and iron deficiency, COPD, and cachexia 5,6 influence the design and the outcome of clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Steps forward in regulatory pathways for acute and chronic heart failure

Pani

¹

,

Pecorelli

²

,

Rosano

³

et al. 2014

View full text Add to dashboard Cite

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.

show abstract