Risk factors for bleeding in patients receiving fondaparinux after colorectal cancer surgery

Objective: The aim of this study was to identify risk factors for bleeding complications in patients who receive Venous thromboembolism (VTE) prophylaxis with fondaparinux (FPX) after colorectal cancer surgery. Methods: Records of 546 patients who underwent VTE prophylaxis with intermittent pneumatic compression and FPX after colorectal cancer surgery between January 2009 and May 2014 were reviewed. Patient characteristics, surgical procedures, and patient laboratory data were examined to identify risk factors for bleeding complications using univariate and multivariate logistic regression. Results: We reviewed the records of 324 males and 222 females. Median age and BMI were 68.5 years and 22.7 kg/m2, respectively. The number of laparoscopic surgeries was 366. Median operative time and blood loss were 188.5 min and 20 ml, respectively. The incidence (%) of bleeding events was 5.3%. In univariate analysis, age 80 years, BMI 25.0 kg/m2, hypertension, and antithrombotic therapy were associated with a significantly higher incidence of bleeding events. Multivariate analysis identified age 80 years (odds ratio 5.814; 95% confidence interval 2.502-13.278) as an independent risk factor. Conclusion: Age 80 is a risk factor for bleeding in patients who receive FPX for VTE prophylaxis after colorectal cancer surgery

SATISFY‐JP, a phase II multicenter open‐label study on Satralizumab, an anti‐IL‐6 receptor antibody, use for the treatment of pulmonary arterial hypertension in patients with an immune‐responsive‐phenotype: Study protocol

Abstract Pulmonary arterial hypertension (PAH), an intractable disease with a poor prognosis, is commonly treated using pulmonary vasodilators modulating the endothelin, cGMP, and prostacyclin pathway. Since the 2010s, drugs for treating pulmonary hypertension based on mechanisms other than pulmonary vasodilation have been actively developed. However, precision medicine is based on tailoring disease treatment to particular phenotypes by molecular‐targeted drugs. Since interleukin‐6 (IL‐6) is involved in the development of PAH in animal models, and some patients with PAH have elevated IL‐6 levels, the cytokine is expected to obtain potentials for therapeutic targeting. Accordingly, we identified a phenotype with elevated cytokine activity of the IL‐6 family in the PAH population by combining case data extracted from the Japan Pulmonary Hypertension Registry with a comprehensive analysis of 48 cytokines using artificial intelligence clustering techniques. Including an IL‐6 threshold ≥2.73 pg/mL as inclusion criteria for reducing the risk of insufficient efficacy, an investigator‐initiated clinical study using satralizumab, a recycling anti‐IL6 receptor monoclonal antibody, for patients with an immune‐responsive phenotype is underway. This study is intended to test whether use of patient biomarker profile can identify a phenotype responsive to anti‐IL6 therapy