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Tissue Plasminogen Activator Gene Variations in Patients With Severe Sepsis Influence Response to Tifacogin Therapy: Presented at ATS By Cathy Yarbrough SAN DIEGO -- May 20, 2009 -- In patients with sepsis, a homozygous deletion (DD) genotype in the tissue plasminogen activator (tPA) gene was associated with increased mortality, according to a study presented here at the International Conference of the American Thoracic Society (ATS). The researchers also reported that tifacogin significantly lowered mortality in sepsis patients with this genotype (odds ratio [OR] = .204; 95% confidence interval [CI], 0.031-0.95; P = .03, Fisher's Exact). While insertion/deletion (I/D) polymorphism (rs4646972) on the tPA gene was previously shown to be associated with thrombosis risk, the study is the first to demonstrate its role in shock or organ failure in patients with severe sepsis, said Jiwang Chen, PhD, Northwestern University's Feinberg School of Medicine, Chicago, Illinois, on May 17. The researchers analysed the tPA polymorphisms from patients who participated in a completed phase 3 clinical trial of the recombinant form of tissue factor pathway inhibitor (TFPI). The trial suggested that tifacogin reduced mortality during the first 9 months of study enrolment. However, in the last 7 months of the study, this trend was reversed in favour of the placebo group. Clinical data were extracted from the closed clinical database of the large phase 3 trial. For haplotype analysis, the scientists genotyped 21 additional haplotype-tagged single nucleotide polymorphisms in the tPA gene. The analysis revealed that placebo DD patients had significantly higher mortality than deletion-insertion (DI) and homozygous insertion (II) patients in the trial. The benefit of TFPI, an endogenous anticoagulant, in DD patients was most significant in patients with shock (P < .05). In 181 of 184 patients, genotyping of the tPA Alu (short stretches of DNA) I/D polymorphism was successful. Presence or absence of Alu insert results in either a 318 base pair deletion or a 615 base pair insertion product. The homozygous DD genotype was found in 53 patients (29.1% of all patients). One I/D was detected in 70 patients (38.7% of total patients). Two II were found in 58 patients (32.0% of total patients). The overall group and the placebo group were in Hardy Weinberg equilibrium (P > .10). In the entire group, mortality did not vary by genotype. However, placebo DD patients had significantly higher mortality than DI/II patients. [Presentation Title: Tissue Plasminogen Activator (tPA) Polymorphism Associated With Response to Tifacogin in Severe Sepsis. Poster D32] E-mail this page to a friend or colleague! To print, use this version