Anemia

Anemia is a common complication of chronic kidney disease (CKD). According to the National Health and Nutrition Examination Survey (NHANES), the prevalence of anemia is over 15% in US adults with CKD. As kidney function declines, anemia becomes more common: in adults with stage 4 or 5 CKD, the prevalence of anemia exceeds 50%. Among patients undergoing maintenance dialysis, anemia is nearly universal.

For decades, the primary medical treatment for anemia associated with CKD has been erythropoiesis-stimulating agents (ESAs), including epoetin alfa (Epogen), darbepoetin alfa (Aranesp), and pegylated epoetin beta (Mircera). Today, over 80% of US patients on hemodialysis use ESAs monthly, while 50% of patients on peritoneal dialysis do so. Due to long-standing concerns about cardiovascular safety, use of ESAs in patients with non–dialysis-dependent CKD is much lower. However, a new era of treatment appears imminent. A new class of medications, hydroxy-inducible factor (HIF) stabilizers, has begun to enter clinical practice in East Asia and may enter the US in the near future. Because HIF stabilizers are oral medications, the class is much more convenient to use. Nevertheless, despite many registration trials that have clearly established the efficacy of HIF stabilizers, the safety of the class relative to both placebo and ESAs remains uncertain.

CDRG has been involved in research on CKD-related anemia for more than two decades. The group has worked with multiple drug manufacturers to develop evidence about the efficacy and safety of ESAs, as well as the role of healthcare policy in shaping their use. Highlights of past work include:

• Measuring associations of hemoglobin and hemoglobin variability with clinical outcomes in patients undergoing dialysis
• Post-market assessment of the safety of peginesatide
• Evaluation of changes in cardiovascular outcomes after revisions to US Food and Drug Administration recommendations for ESA dosing
• Evaluation of changes in transfusion use after revisions to Centers for Medicare & Medicaid Services payment policy on outpatient dialysis

Whether your company is developing new anemia medications, searching for a partner to guide post-market surveillance, or aiming to forecast the influence of a proposed payment policy on treatment use, CDRG can offer expert analysis and insight.

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