| Summary: | Recent post hoc analyses of large randomized clinical trials have suggested an association between high ESA dose and cardiovascular events (Szczech et al. 2008 KI 74:791). In 2011, implementation of CMS ESRD bundled payment and FDA-mandated ESA label changes that target lower hemoglobin (Hb) created further downward pressure on ESA doses. Long-term safety of intravenous (IV) iron is poorly understood. This study evaluated temporal changes in the ratio of IV iron-to-epoetin use across patients (N=200,170) from a large dialysis organization from 2008 through 2011.
Mean IV iron use was normalized to mg/month. Mean epoetin was normalized to U/month. The IV iron-to-epoetin ratio was calculated by taking the mean IV iron value relative to mean epoetin (per 1000U/month) for Q1 2008 – Q4 2011.
Although mean epoetin utilization has fallen since start of Q3 2010, mean IV iron utilization has remained fairly stable. From Q1 2008 to Q3 2010, the ratio of IV iron-to-epoetin was constant (2.5 mg/month for every 1000 U per month), but has risen 46% from Q3 2010 to Q4 2011, while hemoglobin levels have fallen 0.9g/dL (11.5 to 10.6g/dL).
While ESA doses decreased, iron doses remained constant, resulting in a shift toward a higher ratio of iron-to-ESA use from Q3 2010 through Q4 2011. Further analyses are warranted to understand the appropriate balance between iron and ESA use with regards to efficacy and safetyfx1
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