Ferric gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin

Abstract

The Dialysis Patients Response to IV Iron with Elevated Ferritin (DRIVE) study demonstrated the efficacy of intravenous ferric gluconate to improve hemoglobin levels in anemic hemodialysis patients who were receiving adequate epoetin doses and who had ferritin levels between 500 and 1200 ng/ml and transferrin saturation (TSAT) < or = 25%. The DRIVE-II study reported here was a 6-wk observational extension designed to investigate how ferric gluconate impacted epoetin dosage after DRIVE. During DRIVE-II, treating nephrologists and anemia managers adjusted doses of epoetin and intravenous iron as clinically indicated. By the end of observation, patients in the ferric gluconate group required significantly less epoetin than their DRIVE dose (mean change of -7527 +/- 18,021 IU/wk, P = 0.003), whereas the epoetin dose essentially did not change for patients in the control group (mean change of 649 +/- 19,987 IU/wk, P = 0.809). Mean hemoglobin, TSAT, and serum ferritin levels remained higher in the ferric gluconate group than in the control group (P = 0.062, P < 0.001, and P = 0.014, respectively). Over the entire 12-wk study period (DRIVE plus DRIVE-II), the control group experienced significantly more serious adverse events than the ferric gluconate group (incidence rate ratio = 1.73, P = 0.041). In conclusion, ferric gluconate maintains hemoglobin and allows lower epoetin doses in anemic hemodialysis patients with low TSAT and ferritin levels up to 1200 ng/ml.

Figure 1.

A schematic of patient disposition in DRIVE-II.

Figure 2.

Epoetin dose throughout DRIVE-II. Baseline weekly epoetin doses were similar in the 2 groups, resulting in similar DRIVE epoetin doses. By wk 12, epoetin doses had dropped significantly lower in the intravenous ferric gluconate group (solid line) than the control (dashed line) (P = 0.017). Final epoetin doses were similar to their baseline (pre-25% epoetin dose increase) counterparts in the intravenous ferric gluconate group (P = not significant), whereas they were significantly higher in the control group (P < 0.05).

Figure 3.

Hemoglobin values throughout DRIVE-II. Ferric gluconate (solid line); control (dashed line).

Figure 4.

Transferrin saturation at baseline, end of DRIVE (wk 6), and end of DRIVE-II (wk 12). Ferric gluconate (solid line); control (dashed line).

Figure 5.

Serum ferritin at baseline, end of DRIVE (wk 6), and end of DRIVE-II (wk 12). Ferric gluconate (solid line); control (dashed line).

Figure 6.

A schematic of the study procedures of DRIVE and DRIVE-II. L, comprehensive laboratory testing; H, hemoglobin and reticulocyte hemoglobin content (CHr) testing; X, 125 mg intravenous ferric gluconate administration.