DW Coyne: Quality of life in the Normal Hematocrit Trial 1.5-fold increase in epoetin dose, followed by further increases at 2- week intervals as needed to reach a target of 14±1 g/dl. Those randomized to the lower target (Group B) had epoetin doses adjusted to maintain a Hgb level of 10±1 g/dl. Contrary to the trial’s name, Hgb—not hematocrit—was determined, and hemato- crit was calculated by multiplying the Hgb level by three. According to the ACTR, page 2, ‘The primary objective of this study was to assess the effects of the two hematocrit targets, 42 and 30%, on morbidity and mortality in dialysis patients with clinically evident cardiac disease who were receiving Epoetin alfa therapy. Quality of life was also evaluated.’ The primary end point was death and nonfatal myocardial infarct. ‘Secondary end points included all- cause mortality alone, MI alone, all-cause hospitalization, congestive heart failure (CHF), unstable angina, coronary artery bypass graft, (CABG), percutaneous transluminal coronary angioplasty (PTCA), quality of life, and transfusions, as well as changes in cardiac medications.’(ACTR, page 38). ‘All-cause mortality alone and all- cause hospitalization were also compared between treatment groups using the log-rank test and ﬁtting Cox proportional hazards regression models. Other secondary end points such as acute MI, CHD, unstable angina, CABG, PTCA, and transfusions were compared between groups using chi-square tests.’ (ACTR, page 38). The ACTR stated on pages 44 and 45, ‘Health related Quality of Life (HRQOL) Study’: ‘Patients completed a quality-of-life ques- tionnaire (the Medical Outcomes Study 36-Item Health Survey [SF-36]) at baseline and every 6 months. The SF-36 is a medical outcomes instrument that has been validated in prior studies of ESRD patients.’ ‘The primary HRQOL end points chosen prospec- tively for this study were the vitality scale, the physical function scale, and the mental health index scale. Secondary end points were the bodily pain scale, the physical role limitation scale, the emotional role limitations scale, and the social function scale. Area under the curve was calculated for an 18-month period. The last known value was carried forward for missing data.’ The ACTR also stated on page 78 that a ‘general category of ‘other thrombotic events’ was (prospectively) established because there was concern regarding the use of epoetin to correct anemia and these outcomes.’ DISCLOSURE DWC is a consultant to Abbott, Alnylam, Chiasma, and Sanofi Aventis. He is a speaker for Abbott and Watson. None of these entities make ESAs. He has participated in numerous trials of erythropoiesis- stimulating agents and intravenous iron products. Author contributions DWC solely developed the idea of this report, obtained and analyzed the clinical data report from the FDA, and wrote the manuscript. REFERENCES 1. Besarab A, Bolton WK, Browne JK et al. The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin [see comment]. N Eng J Med 1998; 339: 584–590. 2. Stack AG, Bloembergen WE. 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