Fifty-five patients on maintenance hemodialysis underwent bone-marrow aspirations for evaluation of iron stores that were to be compared to concomitant measurements of hematocrit, red blood cell volume, serum iron concentration, total iron binding capacity, transferrin saturation, and serum ferritin concentration. In 42 patients (76.4%), the bone marrow iron stores were found to be absent or deficient. Mean hematocrit for the total group was 26.4%, and red blood cell volume measurement showed a mean value of 41.1% of predicted normal. Results also indicated that serum ferritin was the best predictor of iron storage levels, with diagnostic thresholds of 80 to 350 ng/ml derived from statistical analysis of the data. Other hematologic parameters studied had significantly less correlation with bone-marrow iron stores.
Safety, tolerability and efficacy of volixibat in adults with non-alcoholic steatohepatitis:24-week interim analysis results from a randomized, double-blind, phase II study Histologic assessments at week 48 (n = 43) Interim analysis at week 24 (n = 80) 197 adults with ≥5% steatosis and biopsy-confirmed NASH received volixibat (5, 10 or 20 mg) or placebo for 48 weeks C4 (bile acid synthesis) +38.5 ng/ml Total cholesterol -14.5 mg/dl LDL cholesterol -16.1 mg/dl Evidence of adequate target engagement De novo production of bile acids from cholesterol Volixibat 5, 10 or 20 mg No effect of volixibat on MRI-PDFF or serum ALT levels Volixibat dose 30.0%
HighlightsVolixibat decreased serum C4 (bile acid synthesis biomarker) and cholesterol, indicating adequate target engagement.Volixibat had no therapeutic impact on steatosis or liver injury in NASH.Treatment-emergent adverse events were mainly of mild or moderate grade.No serious adverse events were attributed to volixibat.
The risks of intermittent anticoagulation with heparin for hemodialysis and long-term anticoagulation with warfarin to prevent clotting of arteriovenous shunts were assessed in a group of 125 home dialysis patients. Over a 7-year period, there were nine bleeding complications attributable to heparin anticoagulation for an incidence of one complication for every 40 patient years on dialysis. In contrast, 20 of 48 patients anticoagulated with warfarin for an average of 2 years each, had a total of 50 hemorrhagic complications requiring 542 days in the hospital and 15 operative procedures. Conversion to an alternative form of vascular access, the internal arteriovenous fistula, obviated the need for warfarin therapy and its unacceptably high complication rate in this population of patients.
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