Lower Ceiling for Hb Levels Recommended
The document, released here at the foundation's annual meeting, follows the FDA's issuance of a black box warning for the drugs. The warning states that ESA regimens for increasing hemoglobin (Hb) levels to above 13.0 g/dL in non-dialysis CKD patients heightens the risk of death, blood clots, MIs, and stroke.
The current NKF guidelines were published in May 2006. The work group that developed the recommendations reconvened last February to update their proposal. The draft, which was unveiled here at the NKF 2007 Spring Clinical Meetings, is being circulated for comment and possible revision before being finalized and published.
The panel's recommendation that Hb targets should be below 13 g/dL is based on a review of all-cause mortality and adverse cardiovascular events in clinical trials in which patients were assigned to Hb targets above 13.0 g/dL. For dialysis and non-dialysis patients assigned to Hb targets above 13.0 g/dL, the group considered the evidence to be of “moderately high quality” for showing harm—in the form of cardiovascular events—and of “high quality” for showing lack of benefit.
David Van Wyck, MD, co-chair of the work group, observed: “The statement about Hb targets above the 13.0 g/dL threshold reflects our judgment that greater weight should be given to potential harm than to uncertain benefit.”
After the release of the draft, Amgen, the maker of the ESA epoetin, issued the following statement: “Like others in the nephrology community, we just received the new draft guidelines and are reviewing them now. It is premature for Amgen to comment on the specifics at this time, but we continue to support the creation and updating of robust, independent and evidence-based clinical practice guidelines. We continue to believe that clinical practice guidelines assist in setting appropriate standards for health-care delivery.”
The company also noted that its “top priorities are patient safety and the appropriate use of all of our products. Amgen always recommends that physicians and other prescribers carefully follow FDA-approved prescribing instructions for our products.”