NN&I - April 2010
22 Nephrology News & Issues April 2010www.nephronline.comPatient Management This research was funded with an educational grant from Watson Laboratories. Introduction IV iron is a fundamental component of management for the hemodialysis patient with anemia. A number of random -ized, controlled trials have shown that IV iron was effec- tive in raising Hb and Hct levels.1-6 Also, IV iron improved response to ESAs, thereby allowing for a reduction in ESA dosage.6 In comparison, oral iron supplementation has not been shown to be demonstrably more effective than either placebo or no iron intervention.4Although the IV route of iron administration is strongly recommended in the anemic patient on hemodialysis,1 there is continued discussion on how IV iron can be used most effectively to improve anemia and optimize treatment costs. There are three central issues related Refining the approach to IV iron use in hemodialysis patients: a post-DRIVE analysisBy Amit Sharma, MD, FACP, FASN, Kirsten Vanderhalt, Kenneth J. Ryan, PhD, and Jo Sclafani, PharmDto this discussion. One is the use of serum ferritin to guide decision-making in IV iron dosing. The second is the poten -tial advantages of regular, low-dose IV iron regimens over intermittent repletion regimens. And the third is the ability of IV iron to overcome ESA hyporesponsiveness, reduce the overall ESA burden, and improve the cost-effectiveness of anemia care. Many hemodialysis providers tend to withhold IV iron at higher serum ferritin levels on the assumptions that a higher serum ferritin level (eg, >500 ng/mL) reflects an iron-replete state and that further IV iron use under these circumstances may not be beneficial. The Dialysis Patients' Response to IV Iron With Elevated Ferritin (DRIVE) and DRIVE-II studies explored these issues in patients with serum ferritin levels between 500 and 1,200 ng/mL. At our institution, lessons learned from the DRIVE and DRIVE-II studies were applied to our ane-mia management program in an effort to improve anemia outcomes. Lessons learned from the DRIVE studies The DRIVE and DRIVE-II studies evaluated improve-ments in anemia parameters and changes in ESA require -ments in hemodialysis patients with higher serum ferritin levels (500-1200 ng/mL) and lower transferrin saturation (TSAT) levels (\03725%).6,7 These patients also had marked ESA hyporesponsiveness, as shown by low Hb levels despite the use of high ESA doses (\03622,500 mg/wk).7 The DRIVE studies comprised two, six-week phases. The first six-week phase randomized patients to receive a repletion course of IV iron (1 g of ferric gluconate given in divided doses over 8 consecutive hemodialysis sessions) or no iron.7 DRIVE-II was a six-week observational extension of DRIVE in which participants returned to routine IV iron management (investigators were not restricted in the type of iron product administered). DRIVE-II was designed to determine how the IV iron repletion regimen administered during DRIVE impacted serum ferritin, Hb, and TSAT levels, as well as overall ESA requirements.6 Abstract Intravenous (IV) iron is a necessary component of the anemia man-agement plan for the hemodialysis patient. Despite the demonstrated benefits of IV iron, questions remain as to the most effective strategies for using IV iron to maintain target hemoglobin (Hb) levels, ensure adequate iron supply, and optimize erythropoiesis-stimulating agent (ESA) therapy. Significant questions also surround the extent of the serum ferritin marker to reliably guide IV iron treatment decisions. The recent Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) and DRIVE-II studies showed that improvements in Hb levels, iron status, and ESA responsiveness can be achieved with a repletion course of IV iron in patients with serum ferritin levels up to 1200 ng/ mL. These studies also demonstrated that higher serum ferritin levels are a poor predictor of positive response to IV iron. We sought to apply the lessons learned from the DRIVE studies in our hemodialysis clinic. We designed this retrospective study to determine if regular, low-dose IV iron administered to patients with serum ferritin levels up to 1200 ng/ mL could improve measures of anemia and iron status while optimizing the use of IV iron and ESAs. Dr. Sharma is director of clinical research at the Boise Kidney and Hypertension Institute (BKHI) in Meridian, Idaho. Ms. Vanderhalt was the Administrative Director for Research at BKHI at the time this research was conducted. Dr. Ryan is an assistant professor in the Department of Applied Statistics and Operations Research at Bowling Green State University in Bowling Green, Ohio. Dr. Sclafani is the medical liaison for Watson Laboratories, Inc. with prior experience managing anemia therapy for CKD and dialysis patients at Kaiser Permanente in San Diego and Riverside, Calif. as a clinical pharmacist. The authors would like to thank Patty Brown in assisting with the writing of this manuscript. Patient Management_0410_7.indd 22 3/19/10 2:00:33 PM
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