04/06/2012 VHIR's study proves that DAa doesn't reduce the mortality of the septic shock 04/06/2012 In 2001, Drotrecogin alpha (activated) (DAa) was approved by the FDA for the treatment of the serious sepsis on the basis of the results of the study PROWESS. On the basis of a clinical multinational multicentral trial, double blind and controlled with placebo, DAa reduced in 6 % the mortality of the serious sepsis at the 28 days. In spite of it, and having in consideration its high cost, DAa's efficiency has been questioned, with a negative recommendation of use for the Agency of Valuation of Medical Technologies of Catalonia. The criteria of approval by the FDA were based on a score (that is obtained retrospectively) and the European Medicines Agency (EMEA) adopted different criteria.In 2007, EMEA concluded that the doubts accumulated on DAa's efficiency justified a new clinical trial controlled with placebo. Ordered by EMEA, in 2008 begins the studyPROWESS-SHOCK, a clinical multinational multicentral trial, double blind and controlled with placebo to confirm DAa's efficiency in the septic shock.The results of the study have been published in New England Journal of Medicine (NEJM), with the participation of researchers form the groups SODIR (J. Carlos Ruiz Rodríguez) and CRIPS (Jordi Rello) of Vall d'Hebron Research Institute (VHIR). In this clinical international trial, DAa does not reduce the mortality of the septic shock neither in 28 days nor in 90 days. The absence of benefit was uniform in all the predefined subgroups of analysis. Though the mortality of the placebo group was low compared with historical series, it is coherent with recent studies and clinical trials. On the basis of these results, the promoter has withdrawn the medicament of commercialization.Dr. Rello, after having analyzed the results, comments that "it is a pity that the warnings that we formulated in an editorial in Critical Care Medicine 7 years ago have been fulfilled. After more than 20 years of studies with adjuvant treatments in the sepsis, the promising studies of initial phases haven't been ratified. It is necessary to learn from these results and design studies centred on the more serious subgroup of patients in septic shock". "http://www.ncbi.nlm.nih.gov/pubmed?term=Rello%20J%20%26%20Ruiz-Rodriguez%20JC" N Eng J Med 2012. (10.1056/NEJMoa1202290, PMI 22616830) In 2001, Drotrecogin alpha (activated) (DAa) was approved by the FDA for the treatment of the serious sepsis on the basis of the results of the study PROWESS. On the basis of a clinical multinational multicentral trial, double blind and controlled with placebo, DAa reduced in 6 % the mortality of the serious sepsis at the 28 days. In spite of it, and having in consideration its high cost, DAa's efficiency has been questioned, with a negative recommendation of use for the Agency of Valuation of Medical Technologies of Catalonia. The criteria of approval by the FDA were based on a score (that is obtained retrospectively) and the European Medicines Agency (EMEA) adopted different criteria.In 2007, EMEA concluded that the doubts accumulated on DAa's efficiency justified a new clinical trial controlled with placebo. Ordered by EMEA, in 2008 begins the studyPROWESS-SHOCK, a clinical multinational multicentral trial, double blind and controlled with placebo to confirm DAa's efficiency in the septic shock.The results of the study have been published in New England Journal of Medicine (NEJM), with the participation of researchers form the groups SODIR (J. Carlos Ruiz Rodríguez) and CRIPS (Jordi Rello) of Vall d'Hebron Research Institute (VHIR). In this clinical international trial, DAa does not reduce the mortality of the septic shock neither in 28 days nor in 90 days. The absence of benefit was uniform in all the predefined subgroups of analysis. Though the mortality of the placebo group was low compared with historical series, it is coherent with recent studies and clinical trials. On the basis of these results, the promoter has withdrawn the medicament of commercialization.Dr. Rello, after having analyzed the results, comments that "it is a pity that the warnings that we formulated in an editorial in Critical Care Medicine 7 years ago have been fulfilled. After more than 20 years of studies with adjuvant treatments in the sepsis, the promising studies of initial phases haven't been ratified. It is necessary to learn from these results and design studies centred on the more serious subgroup of patients in septic shock". "http://www.ncbi.nlm.nih.gov/pubmed?term=Rello%20J%20%26%20Ruiz-Rodriguez%20JC" N Eng J Med 2012. (10.1056/NEJMoa1202290, PMI 22616830) Twitter LinkedIn Facebook Whatsapp
