BACKGROUND: This study is part of a 3-country study testing whether normal levels of hemoglobin (Hgb) delay the progression of left ventricular (LV) growth in chronic kidney disease (CKD) patients not on dialysis. METHODS: This was an open-label, randomized, multicenter, controlled trial conducted in 27 tertiary-care hospitals in Italy. Treated subjects (n=46) received epoetin-alpha (EPO-alpha) to maintain Hgb levels in the range 12-14 g/dL. Control subjects (n=49) were not treated unless their Hgb decreased to 9.0 g/dL. Primary outcome was LV mass index (MI) change after 24 months. Subcutaneous EPO-alpha was withdrawn in Europe and the study prematurely terminated; therefore, a 12-month analysis was carried out. RESULTS: Mean age was 57 years (38% were women, 18% with diabetes, 76% taking ACEI or ARB and 22% statins). EPO-alpha median final dose was 2,000 IU/week. Hgb significantly increased (12.4 -/+ 1.1 g/L) for the treatment group and decreased for controls (11.3 -/+ 1.3 g/L; p<0.001). The intention-to-treat analysis was conducted in 78 patients. Mean baseline LVMI for treated patients and controls was 109.5 -/+ 23 g/m2 and 108.7 -/+ 29 g/m2, respectively. LVMI did not change among controls, whereas it decreased slightly, though not significantly, among treated patients. CONCLUSIONS: The current Italian trial was negative, maybe due to its limitations: lack of power, 1-year follow-up and normal LVMI in some patients at start; however, it was consistent with other published studies. Thus, it is unlikely that targeting hemoglobin in the normal range for CKD patients is of benefit.

Italian randomized trial of hemoglobin maintenance to prevent or delay left ventricular hypertrophy in chronic kidney disease.

CIANCIARUSO, BRUNO;
2008

Abstract

BACKGROUND: This study is part of a 3-country study testing whether normal levels of hemoglobin (Hgb) delay the progression of left ventricular (LV) growth in chronic kidney disease (CKD) patients not on dialysis. METHODS: This was an open-label, randomized, multicenter, controlled trial conducted in 27 tertiary-care hospitals in Italy. Treated subjects (n=46) received epoetin-alpha (EPO-alpha) to maintain Hgb levels in the range 12-14 g/dL. Control subjects (n=49) were not treated unless their Hgb decreased to 9.0 g/dL. Primary outcome was LV mass index (MI) change after 24 months. Subcutaneous EPO-alpha was withdrawn in Europe and the study prematurely terminated; therefore, a 12-month analysis was carried out. RESULTS: Mean age was 57 years (38% were women, 18% with diabetes, 76% taking ACEI or ARB and 22% statins). EPO-alpha median final dose was 2,000 IU/week. Hgb significantly increased (12.4 -/+ 1.1 g/L) for the treatment group and decreased for controls (11.3 -/+ 1.3 g/L; p<0.001). The intention-to-treat analysis was conducted in 78 patients. Mean baseline LVMI for treated patients and controls was 109.5 -/+ 23 g/m2 and 108.7 -/+ 29 g/m2, respectively. LVMI did not change among controls, whereas it decreased slightly, though not significantly, among treated patients. CONCLUSIONS: The current Italian trial was negative, maybe due to its limitations: lack of power, 1-year follow-up and normal LVMI in some patients at start; however, it was consistent with other published studies. Thus, it is unlikely that targeting hemoglobin in the normal range for CKD patients is of benefit.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/363039
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