Cardiovascular Clinical Trialists (CVCT) Forum – Interpretation and approvability issues.

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Interpretation and approvability issues.Industry viewpoint: Paul AUDHYA, Reata, USARegulatory viewpoint: Pieter DE GRAEF, EMEA, NEDAbstract : L’auteur n’a pas transmis de conflit d’intérêt concernant les données diffusées dans cette vidéo ou publiées dans la référence citée.Conférence enregistrée : 9th Global Cardiovascular Clinical Trialists Forum • Paris 2012 Cardiovascular prevention in chronic kidney disease. New therapeutic options and future opportunities- Cardiovascular events are 10 to 20 fold higher in CKD patients. Heart failure is the main cardiovascular complication that occurs in renal patients. Nearly all CV prevention and heart failure trials excluded patients with moderate to severe CKD. Therefore, the general approach and recommendations for CV prevention in the general population may not be equally effective and completely safe in renal patients.- Renal failure is associated with increased vascular inflammation and oxidative stress linked to development of cardiovascular disease. Nrf-2 (NF-E2-related factor 2) is a regulator of anti-oxidant, anti-inflammatory and detoxification pathways. Intervention trials of the synthetic nrf2/nf?b modulator, bardoloxone methyl, in patients with advanced kidney disease associated with type 2 diabetes, demonstrated improvement of renal function (BEAM trial), suggesting that such agents may have therapeutic benefit in chronic renal failure.- The ongoing BEACON trial assesses the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease and cardiovascular deaths in patients with Stage 4 CKD and type 2 diabetes.- More specifically in chronic hemodialysis patients, results from the very few clinical trials undertaken thus far, including trials on lipid reduction, normalization of hematocrit, and increased dialysis dosage, have been unsuccessful.- New CV prevention opportunities are being investigated in specific trials in CKD and hemodialysis patients.The aim of this workshop is to discuss innovative designs and execution plans of CV prevention trials in CKD as well as the interpretation and implementation of the results of such trials and the approvability - regitrsbaility of potentially new CV prevention in CKD indications.Chairpersons: David GOLDSMITH, London, GBR - Luis RUILOPE, Madrid, ESPRéalisation, production : Canal U/3S et CERIMESKeyword : Cardiovascular Clinical Trialists, Paris, 2012, Cardiovascular prevention, Baro-stimulation