Table 3.

Controlled trials of Epo versus placebo in adults and children receiving chronic intermittent hemodialysis

TrialNo. Epo/No. PlacDesign: BP Meds Adjusted in AllMean/SD BP, mmHgHtn AEsFollow- Up, mos
Neeman (42)50/50Pooled pediatric hemodialysis and CAPD, 12 wkΔDBP +7.0 > placebo (P = 0.03) ΔSBP +1.9 > placebo (P = 0.57) ΔMAP +4.1 > placebo (P = 0.047) Hemo Subset 23/22: ΔDBP +12.4, ΔSBP +10.9; nearly all of the BP effect is in hemodialysis patientsNot reported3 mos, overall trial Hct increase was from 22.0% to 30.9% in 3 mos
Klinkmann (43,44)181/181 [Both reports refer to the same data)HemodialysisNot reportedSerious AE HTN: 10.5% Epo, 3.9% placebo, Serious AE HTN encephalopathy: 5.0% Epo,1.1% placebo9 mos
Suzuki (94)59 hi/58 lo/57 placHemodialysisEPO high vs. placebo: SBP increased (P < 0.01), DBP increased (P < 0.05), BP meds increased more in EPO armsHeadaches associated with HTN more common in Epo arms2 mos
Canadian (90)38 hi/40 lo/40 placHemodialysisEpo high vs. placebo: ΔSBP +4 (ns) ΔDBP +8 (P < 0.001)Severe HTN leading to withdrawl: 6 Epo vs. 0 placebo7 mos
Bahlmann (92)63/66HemodialysisNot reportedRequired increased BP meds: 28% Epo vs. 11% placebo Severe HTN (220/100): 5.7% Epo vs. 6.5% placebo1 mo
Abraham (89)151/78Hemodialysis: entire trialEpo vs. placebo: ΔSBP +6 (ns) ΔDBP +6 (P < 0.05)Increased BP meds or ΔDBP >+10: Epo vs. placebo (P = 0.005, odds ratio 2.3)2.5 mos
Abraham (45)87/45Hemodialysis: subset receiving no BP meds at baseline or during study drugEpo vs. placebo ΔSBP +13 (P < 0.05) ΔDBP +6 (P < 0.05)Δ DBP > +10: Epo vs. placebo 48 vs. 24%, P = 0.01 Odds ratio 2.92.5 mos
  • All trials permitted ongoing/escalated treatment of BP changes as standard of care.