The 2006 K/DOQI anemia guidelines for CKD: Key updates

The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines for the management of anemia in chronic kidney disease (CKD) were updated this past spring for the second time since their initial publication in 1997. The charter guidelines focused on the treatment of anemia in dialysis-dependent end-stage renal disease (ESRD) patients. In 2001, these guidelines were broadened to include the subpopulation of CKD patients who were not on dialysis. These most recent update pertains to non-dialysis–dependent CKD patients stages 1 through 5, dialysis-dependent (either hemodialysis or peritoneal dialysis) ESRD patients, and renal transplant patients. This update was prompted by evidence from various clinical and observational studies that primarily addressed the target hemoglobin (Hgb) level for patients with CKD. These new guidelines differ from previous ones in the significance accorded this evidence. They can be regarded as either guidelines or recommendations for clinical practice. The evidence comes not only from studies conducted in the United States but also from those conducted in Canada, Europe, the United Kingdom, Mexico, and the Middle East. The European Best Practice guidelines from 2004 were also evaluated. The three key changes made in the current K/DOQI guidelines are outlined in Table I. These changes include the definition of anemia, the target Hgb level, and the target iron status as measured by transferrin saturation and ferritin level. The update was prompted by evidence from various clinical and observational studies that primarily addressed target Hgb levels for patients with CKD. In the new guidelines, anemia is defined as Hgb concentration below the fifth percentile for the gender-specific adult population.1 Specifically, patients are now considered anemic when they have Hgb levels <13.5 g/dL if male and <12.0 g/dL if female. Previous guidelines specified the threshold Hgb levels at <12.0 and <11.0 g/dL, respectively. The definition was changed due to the source data used to set these parameters; the current guidelines analyzed data from the Third National Health and Nutrition Examination Survey (NHANES III)1 and do not account for a downward adjustment in the parameters for males. The second key change in the current guidelines is the target Hgb level. The 2001 guidelines, recommended a target Hgb level of 11.0–12.0 g/dL in CKD patients, but the new guidelines recommend a target of at least 11.0 g/dL. This change reflects the most important factor benefiting treatment outcome, namely, quality of life for the patient. Studies have shown that patients maintained at higher Hgb levels are less depressed and tired, and experience improved vitality—that is, a better overall quality of life. Furthermore, data from 22 randomized controlled trials conducted between 1989 and 2005 showed that achieving higher Hgb levels correlated with a lower mortality rate, fewer hospitalizations, less severe left ventricular hypertrophy, and no increase in the number of adverse events. A note of caution has been issued about intentionally keeping Hgb levels above 13 g/dL. Currently, there is insufficient data to support this practice. One clinical trial showed increased incidence of cerebrovascular events in patients assigned to a target Hgb level of 13.5–14.5 g/dL, when compared with patients at lower target levels of 9.5–11.5 g/dL,2 (4% versus 1% of patients, respectively). The parameters used to measure and monitor iron status in patients are iron saturation (TSAT) and ferritin level. The new guidelines recommend TSAT levels >20% (an upper limit was not provided). The lower limit for ferritin should be 100 ng/mL in non-hemodialysis-dependent CKD patients and 200 ng/mL in hemodialysis-dependent patients. The rationale for these changes is to achieve target Hgb levels with the minimal dose of an erythropoiesis stimulating agent (ESA). An example supporting this explanation comes from a randomized controlled trial by Besarab et al., in which hemodialysis-dependent CKD patients maintained at TSAT levels of 30%–50% had a 40% reduction in ESA dosage compared with that in patients maintained at TSAT levels of 20%–30%.3 A theoretical and clinical risk of iron overload remains with higher target ferritin levels, which is why the K/DOQI guidelines do not routinely recommend levels >500 ng/mL. To date, no randomized clinical trials have been conducted to compare the safety and efficacy of ferritin targets at this level with lower target levels. The lower-limit target ferritin level for non-hemodialysis-dependent CKD patients remains at 100 ng/mL in the new guidelines. The new guidelines have simplified the recommendation regarding the use of pharmacological and nonpharmacological adjuvants to ESAs. At the current status, there is insufficient data to support the use of L-carnitine, ascorbate, or androgens in the treatment of hemodialyzed CKD patients. The new K/DOQI guidelines were formulated following an extensive review of the literature. The guidelines focus on key issues in the management of anemia in CKD patients with the goal of improving patient quality of life. Once the guidelines are put into practice, it will be necessary to evaluate prospectively their impact on the CKD patient population.

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