1.
Burden of illness for patients with non-dialysis chronic kidney disease and anemia in the United States: review of the literature
van Nooten FE, Green J, Brown R, Finkelstein FO, Wish J
Journal of Medical Economics. 2010;13((2):):241-56.
Abstract
OBJECTIVE To assess the health-related quality of life (HRQL) and economic burden of chronic kidney disease (CKD) related anemia in non-dialysis patients in the United States (US) via literature review. METHODS MEDLINE, EMBASE, PROQOLID, and Cochrane Library/Renal Group Resources were searched. Studies were appraised for patient populations, disease-specific versus generic HRQL assessments, and type and magnitude of health-related costs. RESULTS The treatment costs for CKD patients with anemia compared to those without anemia were significantly higher and were blunted but persistent after controlling for comorbidities and confounders. Intervention with erythropoiesis stimulating agents (ESA) decreased anemia and avoided hospital admissions. Costs were higher when anemia was poorly controlled or untreated. HRQL burden was mainly due to physical limitations and difficulty in ability to perform activities of daily living. Significant positive correlations between increases in hemoglobin levels and HRQL measures were reported. CONCLUSIONS Although evidence is limited, the economic and HRQL burden of non-dialysis CKD-related anemia is substantial. Under-treatment of anemia may contribute to higher resource consumption and higher costs; however, patient co-morbidities, use of erythropoietin-stimulating agents, and overall management introduce potential confounds. The contribution of anemia to humanistic disease burden is due to a constellation of factors, including physical activity and functional status.
2.
Recombinant activated factor VII in spinal surgery: a multicenter, randomized, double-blind, placebo-controlled, dose-escalation trial
Sachs B, Delacy D, Green J, Graham RS, Ramsay J, Kreisler N, Kruse P, Khutoryansky N, Hu SS
Spine. 2007;32((21):):2285-93.
Abstract
STUDY DESIGN Randomized, placebo-controlled, double-blind, multicenter, Phase IIa study. OBJECTIVE To assess the safety and efficacy of recombinant-activated Factor VII (rFVIIa) in major spinal surgery. SUMMARY OF BACKGROUND Spinal fusion surgery can cause substantial blood loss and blood product transfusions. Recombinant FVIIa is approved for treatment of bleeding in patients with coagulation abnormalities and has been shown to reduce blood loss and transfusion requirements in surgery in patients with no underlying coagulopathy. METHODS Forty-nine patients undergoing fusion of 3 or more vertebral segments were randomized and treated on losing 10% of their estimated blood volume (with total expected surgical blood loss > or = 20%) and received 3 doses (2-hour intervals) of placebo (n = 13) or 30, 60, or 120 microg/kg rFVIIa (n = 12 per group). The primary endpoint was safety. A priori-defined efficacy endpoints included blood loss and transfusion requirements between placebo and each rFVIIa dose group, adjusted for surgery duration, number of segments fused, and estimated blood volume. RESULTS Serious adverse events did not occur at any greater frequency in any of the treatment groups. One patient (3 x 30 microg/kg rFVIIa) with advanced cerebrovascular disease (undiagnosed, trial exclusion criterion) died 6 days after surgery due to an ischemic stroke. Mean blood loss was as follows: 2270 mL for placebo; 1909, 1262, and 1868 mL for 3 x 30, 3 x 60, and 3 x 120 microg/kg rFVIIa, respectively (differences not statistically significant). Mean adjusted surgical blood loss was as follows: 2536 mL for placebo; 1120, 400, and 823 mL for 3 x 30, 3 x 60, and 3 x 120 microg/kg rFVIIa, respectively (P < or = 0. 001). Mean surgical transfusion volume was reduced by 27% to 50% with rFVIIa treatment (not significant). The mean adjusted surgical transfusion volume was reduced by 81% to 95% with rFVIIa treatment (P < or = 0. 002). CONCLUSION No safety concerns were indicated for the use of rFVIIa in patients at all doses tested; rFVIIa reduced adjusted blood loss and adjusted transfusions during spinal surgery.