Rottembourg J, Guerin A, Diaconita M and Kadri A
Aim: To describe and compare the hematological parameters and anemia medications used in chronic kidney disease (CKD) patients undergoing hemodialysis (HD), before and after switching between the Iron-Sucrose originator (IS), and an Iron-Sucrose Similar (ISS). Methods: An observational single-center longitudinal study comparing the impact of changing from the original intravenous IS (Venofer®), to an ISS (Fer Mylan®), then back to the original IS. The analysis compares retrospective data from three consecutive 26-week IS treatment periods (P1, P2, and P3), versus a prospective 26-week ISS period (P4), followed by a further 26-week prospective period using the original IS (P5). Hemoglobin (Hb) was assessed every two weeks, while serum ferritin, transferrine saturation (TSAT), and C-reactive protein (CRP) were collected twice per period. ESA (darbepoetin alfa [DA]) was prescribed IV once every two weeks and IV iron was given once weekly, except for P5 where it was administered once every two weeks. Dose titration of ESA and IV iron was per institutional protocol to maintain Hb between 11.5 and12 g/dL. Results: Sixty-six patients (68% male) with a mean age of 60 ± 15 years were analyzed. Mean Hb levels remained stable and within the target range during treatment with IS (11.8 ± 1.0 g/dL) (P1 to P3) but decreased significantly after the switch to ISS (11.3 ± 0.9 g/dL) (P4) (p<0.001). Upon switching back to the original IS, Hb target levels were again attained (11.8 ± 0.7 g/dL) (P5). During the P1 to P3 periods, TSAT remained stable (43.7 ± 8.5%) but decreased during the (P4) period (23.9 ± 9.5%) and returned to previous level (41.5 ± 10.8%) with the switch back to IS (P5). Cumulative ESA and IV iron doses were stable during P1 to P3, had to be increased by 27.1% and 30.3% respectively during P4, and could again be decreased by 22.5% and 30.3% with the return to IS during P5. Conclusions: The switch from IS to ISS preparation led to destabilization of the previously well-controlled population of HD patients, with a return to stable levels after a switch back to IS. The switch resulted in an increase in total anemia drug treatment costs, with higher iron and ESA doses required with an ISS. Caution should be exercised before substituting IS with ISS in the absence of therapeutic equivalence data.
