Erythropoietin Deaths In Kidney Disease

[ironjustice]

It wasn't OUR fault , it was THEIRS.

http://www.nature.com/ki/journal/vaop/ncurrent/full/ki201276a.html
The health-related quality of life was not improved by targeting
higher hemoglobin in the Normal Hematocrit Trial
Kidney International advance online publication 21 March 2012
Daniel W Coyne1
1Washington University School of Medicine, Renal Division, St Louis,
Missouri, USA
Correspondence: Daniel W. Coyne, Washington University School of
Medicine, Renal Division,
660 S. Euclid Avenue, Campus Box 8129, St Louis, Missouri 63110, USA.
E-mail: DCo...@dom.wustl.edu
Received 18 October 2011; Revised 22 December 2011; Accepted 3 January
2012
Advance online publication 21 March 2012

Abstract
The Normal Hematocrit Trial (NHT) was the largest trial of epoetin
randomizing 1265 hemodialysis patients with cardiac disease to lower
(9–11 g/dl) or higher (13–15 g/dl) hemoglobin (Hgb), hypothesizing
that higher Hgb would reduce mortality, and improve survival and
quality of life.
The trial was terminated early, and a 1998 publication reported that
targeting higher hematocrit levels led to an insignificant increase in
the primary end points (death or myocardial infarct), or risk ratio
1.3, 95% confidence interval (CI), 0.9–1.90, but the P-value was not
given, and all-cause death risk was not reported.
A higher target reportedly did not increase hospitalization rates, but
did significantly improve the ‘physical function’ domain of quality of
life. Comparing the 1996 Food and Drug Administration (FDA)-filed
clinical trial report to the 1998 publication, however, found several
discrepancies.
Among these, the 1998 article reported interim trial results with only
the adjusted CI but did not state that the unadjusted CIs were
99.912th percentile, and despite being a secondary end point, reported
only the association of achieved Hgb with higher quality of life
score. Randomization to the higher target had actually increased the
risk for the primary end point (risk ratio 1.28, 95% CI=1.06–1.56;
P=0.0112; 99.92% CI=0.92–1.78), the risk of death (risk ratio 1.27,
95% CI=1.04–1.54), non-access thrombotic events (P=0.041), and
hospitalization rate (P=0.04), while ‘physical function’ did not
improve (P=0.88).
Hence, disclosure of these results in the 1998 publication or access
to the FDA-filed report on the NHT in the late 1990s would likely have
led to earlier concerns about epoetin safety and greater doubts about
its benefits.

doi: 10.1038/ki.2012.76

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