14 research outputs found
Quality of Life in Sarcopenia and Frailty
The reduced muscle mass and impaired muscle performance that define sarcopenia in older individuals are associated with increased risk of physical limitation and a variety of chronic diseases. They may also contribute to clinical frailty. A gradual erosion of quality of life (QoL) has been evidenced in these individuals, although much of this research has been done using generic QoL instruments, particularly the SF-36, which may not be ideal in older populations with significant comorbidities. This review and report of an expert meeting presents the current definitions of these geriatric syndromes (sarcopenia and frailty). It then briefly summarizes QoL concepts and specificities in older populations and examines the relevant domains of QoL and what is known concerning QoL decline with these conditions. It calls for a clearer definition of the construct of disability, argues that a disease-specific QoL instrument for sarcopenia/frailty would be an asset for future research, and discusses whether there are available and validated components that could be used to this end and whether the psychometric properties of these instruments are sufficiently tested. It calls also for an approach using utility weighting to provide some cost estimates and suggests that a time trade-off study could be appropriat
Recherche et innovation thérapeutique, une ambition partagée
Qu’est-ce qu’un médicament ? Comment le fabrique-t-on ? Comment passe-t-on d’un produit de la chimie à l’identification d’une molécule biologiquement active, puis à un nouvel outil thérapeutique ? Comment interagissent, pour atteindre ce but, des équipes de chimistes, de biologistes et de médecins ? Comment la recherche académique et la recherche industrielle collaborent-elles et se complètent-elles ?Autant de questions bien (trop) souvent absentes des cursus universitaires, qu’ils soient scientifiques ou médicaux. C’est pour tenter d’y répondre que Servier, l’Inserm et le CNRS ont accepté de partager leur vision à travers une série de textes que médecine/sciences publiera dans les mois à venir et dont voici les premiers.Les enjeux de cette connaissance sont tout à la fois médicaux, économiques et éthiques. De la chimie à la biologie, de la galénique à la pharmacodynamique, de la physiopathologie à la méthodologie des essais cliniques, l’élaboration d’un médicament puise dans toutes ces disciplines qui participent à l’innovation thérapeutique
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Recommendations for the registration of agents to be used in the prevention and treatment of glucocorticoid-induced osteoporosis: updated recommendations from the Group for the Respect of Ethics and Excellence in Science.
OBJECTIVES: The Group for the Respect and Excellence in Science (GREES) has reviewed and updated their recommendations for clinical trials to evaluate the efficacy and safety of new chemical entities to be used in the treatment and prevention of glucocorticoid-induced osteoporosis (GIOP). METHODS: Consensus discussion of the committee. RESULTS: With the exception of steroid use posttransplantation, there is no need to differentiate between underlying diseases. Prevention and treatment for GIOP are dependent on exposure to glucocorticoids rather than T-scores as in postmenopausal osteoporosis (PMO). If fracture data are obtained for PMO, it need not be repeated for GIOP, relying instead on bone mineral density (BMD) trials of at least 1 year. GREES recommends several changes in the previous guidance for GIOP. The committee saw no need to repeat preclinical studies if those have been previously done to assure bone quality in PMO. Similarly, phase I and phase II trials, if careful dose selection has been done for PMO, should not be repeated. The "prevention" and "treatment" claims should remain. Since the most recent evidence suggests significant increase in fracture risk for daily doses of prednisone of 5 mg/day or equivalent, clinical trials should concentrate on patients receiving at least this daily dosage. The emergence of bisphosphonates as the reference treatment, together with the rapid bone loss and high fracture incidence in glucocorticoid users, necessitates recommending a noninferiority trial design with lumbar spine BMD as the primary endpoint after 1 year. CONCLUSIONS: Registration of new chemical entities to be used in the management of GIOP should be granted, based on a 1-year noninferiority trial, using BMD as primary outcome and alendronate or risedronate as comparator. Demonstration of antifracture efficacy should have been previously demonstrated in PMO
Can we identify patients with high risk of osteoarthritis progression who will respond to treatment? A focus on biomarkers ans frailty
Osteoarthritis (OA), a disease affecting different
patient phenotypes, appears as an optimal candidate for
personalized healthcare. The aim of the discussions of the
European Society for Clinical and Economic Aspects of
Osteoporosis and Osteoarthritis (ESCEO) working group
was to explore the value of markers of different sources in
defining different phenotypes of patients with OA. The
ESCEO organized a series of meetings to explore the
possibility of identifying patients who would most benefit
from treatment for OA, on the basis of recent data and
expert opinion. In the first meeting, patient phenotypes were
identified according to the number of affected joints,
biomechanical factors, and the presence of lesions in the
subchondral bone. In the second meeting, summarized in
the present article, the working group explored other
markers involved in OA. Profiles of patients may be defined according to their level of pain, functional limitation, and
presence of coexistent chronic conditions including frailty
status. A considerable amount of data suggests that magnetic
resonance imaging may also assist in delineating
different phenotypes of patients with OA. Among multiple
biochemical biomarkers identified, none is sufficiently
validated and recognized to identify patients who should be
treated. Considerable efforts are also being made to identify
genetic and epigenetic factors involved in OA, but results
are still limited. The many potential biomarkers that could
be used as potential stratifiers are promising, but more
research is needed to characterize and qualify the existing
biomarkers and to identify new candidates