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Pooled analyses of the roxadustat global Phase III
Pooled analyses of the roxadustat global Phase III.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 6303Y AstraZeneca PLC 10 May 2019 \n\nThis announcement contains inside information\n \n10 May 2019 07:00 BST\n \nPooled analyses of the roxadustat global Phase III\nprogramme confirmed cardiovascular safety \n \nCardiovascular safety endpoints evaluated across CKD patients\nnot on dialysis, on incident dialysis and on stable dialysis \n \nBetter outcome vs. epoetin alfa in incident-dialysis patients\nand comparable to placebo in patients not on dialysis\n \nAstraZeneca today announced top-line results from the pooled cardiovascular (CV) safety analyses of the global Phase III programme for roxadustat, a first-in-class hypoxia-inducible-factor prolyl hydroxylase inhibitor (HIF-PHI). The global pivotal Phase III trials evaluated roxadustat for treatment of anaemia in patients with chronic kidney disease (CKD) across the non-dialysis-dependent (NDD), incident (newly-initiated) dialysis (ID), and stable dialysis patient groups.\n \nThese pooled CV safety assessments of roxadustat are part of the overall benefit/risk assessment that will inform discussions with regulatory authorities. One of the key CV safety endpoints is major adverse CV events (defined as MACE), evaluating a composite of all-cause mortality, stroke and myocardial infarction in pooled analyses comparing roxadustat vs. placebo in NDD and vs. epoetin alfa in dialysis-dependent (DD) patients. Another key CV safety endpoint evaluated MACE plus heart failure requiring hospitalisation and unstable angina requiring hospitalisation (defined as MACE+).\n \nPooled MACE/MACE+ in NDD patients\nIn the pooled analysis of over 4,300 patients, and based on the totality of the adjudicated evidence, the MACE/MACE+ analyses between roxadustat and placebo showed no clinically-meaningful difference.\n \nPooled MACE/MACE+ in ID patients\nIn the pool of 1,500 ID patients, a pre-specified sub-population of DD patients, MACE/MACE+ results indicate that ID patients on roxadustat do better than those who are on epoetin alfa. ID patients are a better population to compare roxadustat vs. epoetin alfa than the stable dialysis population, where patients are stable not only on dialysis but also on erythropoietin.\n \nPooled MACE/MACE+ in DD patients\nIn the pooled analysis of around 4,000 patients, and based on the totality of t...