منابع مشابه
Arterial stiffness as surrogate end point: needed clinical trials.
Classic risk scores may underestimate the risk of cardiovascular (CV) events in specific risk groups suitable for primary prevention, such as asymptomatic hypertensive subjects. Particularly, those considered as at intermediate risk may benefit the most from a reassessment of their CV risk using novel biomarkers. In primary prevention, some imaging biomarkers, such as arterial stiffness, enhanc...
متن کاملValidation of 6-minute walk distance as a surrogate end point in pulmonary arterial hypertension trials.
BACKGROUND Nearly all available treatments for pulmonary arterial hypertension have been approved based on change in 6-minute walk distance (Δ6MWD) as a clinically important end point, but its validity as a surrogate end point has never been shown. We aimed to validate the difference in Δ6MWD against the probability of a clinical event in pulmonary arterial hypertension trials. METHODS AND RE...
متن کاملAre hemodynamics surrogate end points in pulmonary arterial hypertension?
BACKGROUND Although frequently assessed in trials and clinical practice, hemodynamic response to therapy has never been validated as a surrogate end point for clinical events in pulmonary arterial hypertension (PAH). METHODS AND RESULTS We performed a patient-level pooled analysis of 4 randomized, placebo-controlled trials to determine whether treatment-induced changes in hemodynamic values a...
متن کاملCFTR biomarkers: time for promotion to surrogate end-point.
In patients with cystic fibrosis, cystic fibrosis transmembrane conductance regulator (CFTR) biomarkers, such as sweat chloride concentration and/or nasal potential difference, are used as end-points of efficacy in phase-III clinical trials with the disease modifying drugs ivacaftor (VX-770), VX809 and ataluren. The aim of this project was to review the literature on reliability, validity and r...
متن کاملDebate: Are surrogate end-point studies worth the effort?
Surrogate end-points of cardiovascular disease can provide useful information in cross-sectional, prospective and interventional studies. They provide information on association with risk factors, natural history and factors associated with disease progression. Because every participant can reach an end-point, sufficient power can be attained with much smaller numbers of subjects in surrogate e...
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ژورنال
عنوان ژورنال: Hypertension
سال: 2012
ISSN: 0194-911X,1524-4563
DOI: 10.1161/hypertensionaha.112.194456