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Table 2 Effects of subcutaneous titrated dosages of erythropoietin in patients not on dialysis on progression to renal replacement therapy

From: Treating anemia of chronic kidney disease in the primary care setting: cardiovascular outcomes and management recommendations

Reference (study design) Level of renal function; trial duration No. of pts Treatment regimen Endpoint Outcome
Dean et al. [55] (retrospective) eGFR 30–59 mL/min/1.73 m2 (n = 71)
eGFR <29 mL/min/1.73 m2 (n = 51)
Hb = 10–11.9 g/dL or 8.0–9.9 g/dL
122 Only pts with ≥8 EPO doses included EPO (Hb targets, doses not specified Change in least-squares slope of inverse serum creatinine clearance vs time before and after EPO Baseline eGFR 30–59 ml/min/1.73 m2:
Pre-EPO rate, dL/mg/yr:
-0.0981 (95% CI, -0.12, -0.07)
Post-EPO rate, dL/mg/yr: -0.0692 (95% CI, -0.09, -0.04)
Weighted mean difference, dL/mg/yr: 0.0454 (95% CI, 0.0150, 0.0757)
Baseline eGFR <29 ml/min/1.73 m2:
Pre-EPO rate, dL/mg/yr: -0.0899 (95% CI, -0.12, -0.06)
Post-EPO rate, dL/mg/yr: -0.0416 (95% CI, -0.06, -0.02)
Weighted mean difference, dL/mg/yr: 0.0493 (95% CI, 0.0272, 0.0679)
Overall:
Pre-EPO rate, dL/mg/yr: -0.0937 (95% CI, -0.11, -0.08)
Post-EPO rate, dL/mg/yr: -0.0569 (95% CI, -0.07, -0.04)
Weighted mean difference, dL/mg/yr: 0.0475 (95% CI, 0.0272, 0.0679) P < 0.05
CREATE study [61] (r) eGFR 15–35 mL/min/1.73 m2, Hb 11.0–12.5 g/dL;3 yrs 300 EPO to 13–15 g/dL Time to dialysis (secondary) eGFR also assessed Change of mean eGFR from baseline:
Year 1:
High-Hb group -3.6 ± 6.7 mL/min
Low-Hb group -3.1 ± 5.3 mL/min
Time to dialysis was significantly shorter in high-Hb group (P = 0.3)
   300 EPO to 10.5–11.5 g/dL   
Gouva et al. [58] (r, mc) SrCr 2–6 mg/dL (eGFR not given), Hb 9.0–11.6 g/dL;22.5 mo 45 Early EPO to Hb≥3 g/dL Composite of doubling of baseline SrCr, renal replacement or death Composite endpoint: Early EPO pts, 29% Deferred EPO pts, 53%; P = 0.0078
Renal replacement: Early EPO pts, 22% Deferred EPO pts, 42%; P = 0.011
   43 Deferred EPO when Hb<9.0 g/dL   
Jungers et al. [59] (c-cs) Predialysis (CrCl ≤15 mL/min) pts (eGFR not given); 24 mo 20 (Hb<10 g/dL) EPO to 11.5 g/dL Change-from-baseline rate of decline in creatinine clearance, time to dialysis Rate of change in creatinine clearance, mL/min/1.73 m2/month: EPO group:
Baseline -0.36 ± 0.16
End of study -0.26 ± 0.15 (P < .05)
Standard care group:
Baseline -0.55 ± 0.48
End of study -0.57 ± 0.44
Time to dialysis: EPO group 16.2 ± 11.9 mo
Standard care group 10.6 ± 6.1 mo (P < 0.01).
   43 (Hb>10 g/dL) Standard care   
Kuriyama et al. [79] (r) SrCr 2–4 mg/dL (eGFR not given), Hematocrit<30%;28 mo median follow-up 31 Standard care Doubling of baseline SrCr Doubling of baseline SrCr
EPO, 52% of pts Standard care, 84% of pts
Nonanemic control, 60% of pts
Progression to dialysis:
EPO, 33% of pts
Standard care, 65% of pts (P = 0.008)
Nonanemic control, 37% of pts
   42 EPO to Hct 33–35%   
  SrCr 2–4 mg/dL, Hematocrit>30%;28 mo median follow-up 35 Nonanemic control   
Rossert et al. [66] (r, mc, uncontrolled)a Iothalamate GFR 25–60 mL/min; 40 mo 108 EPO for Hb 14–15 g/dL (men) and 13–14 g/dL (women) Change-from-baseline GFR as estimated by iohexol clearance GFR change:
High Hb group -0.058 mL/min/1.73 m2
Low Hb group -0.081 mL/min/1.73 m2.
No significant difference between groups
   133 PRN EPO for Hb 11–12 g/dL   
Silverberg et al. [46] (nr) Cockcroft-Gault eGFR decline >1 mL/min per mo; 11.8 mo 84 (NIDDM) EPO to Hb 12.5 g/dL + IV Iron PRN SrCr and CrCl (secondary endpoints) GFR decline halted in both groups
   95 (no NIDDM)    
  1. a Because of labeling changes for EPO, this study terminated after 7.4 and 8.3 months of maintenance in the high and low Hb group, respectively.
  2. c-cs = case-control study; CHF = congestive heart failure;CrCl = creatinine clearance; db = double-blind; EPO = epoetin; (e)GFR = (estimated) glomerular filtration rate; Hct = hematocrit; mc = multicenter; IV = intravenous; mo = months; NIDDM = noninsulin-dependent diabetes mellitus; nr = nonrandomized; PLA = placebo; PRN = as required; pts = patients; r = randomized; SrCr = serum creatinine; wks = weeks.