CIN '2007 - 4th CONGRESS OF NEPHROLOGY IN INTERNET
KDOQI Anemia guidelines 2006: Giving Industry what science could not
Dr Daniel Coyne
Professor of Medicine, Renal Diseases. Washington University School of Medicine. St. Louis, MO,
Abstract
Guidelines are intended to translate complex and varied quality of evidence into useful clinical practice recommendations. The strongest guidelines are consistent with randomized controlled trial (RCT) results, and consequently are evidence-based. The KDOQI Anemia guidelines published May 2006 recommended all CKD and dialysis patients should have hemoglobin (Hgb) maintained at 11 g/dL, and stated this claim was an evidence-based guideline. They also recommended Hgb not routinely be maintained 13 g/dL. This effectively sanctioned the movement of the mean of the bell-shaped distribution of Hgb values in epoetin-treated populations from ~12 g/dL to a value at or near 13 g/dL. As detailed below, the 2006 KDOQI recommendations effectively recommended achieving the mean Hgb achieved in the high arm of the US Normal Hematocrit Cardiac Trial (NHCT), which found an increased risk of death and non-fatal MI’s with a higher Hgb target. The NHCT final results were in fact not reported in 1998. Rather, the New England Journal of Medicine publication reflects the last interim analysis by the Data Safety Monitoring board, which found after adjustment of the statistical testing only a trend toward harm from a higher Hgb target. The final NHCT trial results, as reported recently by the US FDA, reveal more study patients and a primary predefined endpoint which was highly significant for harm from a higher Hgb target (p=0.01; relative risk of death or non-fatal MI 1.28 with the higher target, 95% confidence interval 1.06 to 1.56). The 2006 KDOQI Hgb goals would also have equaled or exceeded the high Hgb arm of the CHOIR study, which also found significantly increased harm with a higher target. The International renal community should demand that guidelines make only conservative RCT-based recommendations.Comments:
- I would like to suggest that guidelines are no longer subsidised by industry and recommend we adopt the recommendations published in the Lancet in 2006 by Richard Steinbrook in which he stated that “Given the billions of dollars at stake for the drug and dialysis industries, such guidance is likely to receive the broadest acceptance if developed without industry support, and by experts without relevant financial associations".
Stanley Shaldon
- Monaco - Thank you for your comment, Stanley. I agree that this would be preferable. The one year cost to US government (Medicare) of the May 2006 KDOQI guideline anemia recommendations greatly exceeds the cost of twnety years of guideline development. Regretably, KDIGO is entirely dependent on Pharma for funding. KDIGO lists only 5 supporters on their web site, and those are arguably the greatest beneficiaries of the pro-drug use guidelines.
Daniel Coyne
Washington Univeristy - United States of America