Global phase III clinical study of losartan confirms its cardiovascular safety

Recently, AstraZeneca released the results of cardiovascular (CV) safety summary analysis of its global phase III clinical study of losartan Losartan is the first hypoxia inducible factor prolyl hydroxylase inhibitor (hif-phi) in the world This trial evaluated the efficacy and safety of rosaristad in the treatment of anemia in patients with non dialysis (NDD), initial unstable dialysis (ID) and stable dialysis chronic kidney disease (CKD) The cardiovascular safety summary analysis is an integral part of the overall benefit risk assessment of losartan, and relevant data will be used to communicate with regulatory authorities before registration In this trial, one of the key end points of cardiovascular safety assessment was set as the main adverse cardiovascular event (defined as MACE) The composite data of all-cause mortality, stroke and myocardial infarction were analyzed by comparing the use of rosaseta and placebo in non dialysis patients, and the use of rosaseta and afayipoten in dialysis patients Another safety critical endpoint was adverse cardiovascular events plus heart failure requiring hospitalization and unstable angina requiring hospitalization (defined as mace +) Mace and mace + results of nondialytic (NDD) patients in the summary analysis of more than 4300 nondialytic patients, based on all the decisive evidence, the analysis results of mace and mace + did not show that there was a clinical difference between Rosa and placebo Mace and mace + results of patients with initial unstable dialysis (ID) were analyzed in a total of 1500 patients with initial unstable dialysis The results of mace and mace + analysis showed that rosaseta showed better safety than afayipoten in the treatment of anemia of patients with initial unstable dialysis As the dialysis treatment and erythropoietin use of stable dialysis patients are relatively stable, 1500 patients with initial unstable dialysis were pre-set as subgroups of dialysis patients in this trial, so as to better show the comparative results of rosarista and afayibotine Mace and mace + results of dialysis (DD) patients in the summary analysis of about 4000 dialysis patients, based on all the decisive evidence, the mace and mace + analysis results did not show that there is a clinical difference between rosarist and afaibertine At present, his overall safety analysis is still ongoing, and will continue to supplement his overall benefit and risk assessment report AstraZeneca and fabergin will initiate communication with the U.S Food and Drug Administration (FDA) to prepare for the registration of the drug and are expected to submit applications in the second half of 2019 At present, China's State Drug Administration has approved losartan for the treatment of anemia in dialysis patients with chronic kidney disease.