Between subjects variability in haemoglobin and dose are not associated with the erythropoiesis-stimulating agent used to treat anaemia in dialysis: a meta-analysis.
OBJECTIVE
We aimed to compare mean and between subject variability in haemoglobin (Hb) and erythropoiesis-stimulating agents (ESA) dose across the ESA compounds used to treat anaemia in dialysis patients.


METHODS
We performed a meta-analysis of randomized trials evaluating ESA in adult patients with chronic kidney disease on dialysis (target Hb 9-13.5 g dl(-1)), and compared mean Hb and its standard deviation (SD), and ESA dose and its coefficient of variation (CV) between the different agents [rHuEPO alfa or beta, darbepoetin alfa, pegylated-epoetin beta (PEG-EPO) or other epoetins]. The effect of route and frequency of administration, frequency of dose adjustments, study blinding and type, baseline value, Hb target and sampling frequency were also assessed.


RESULTS
Among 4983 patients from 16 studies, pooled Hb mean and SD during the evaluation phase were 11.5 g dl(-1) (95% CI 11.3, 11.7) and 0.99 g dl(-1) (0.88, 1.09), respectively. The Hb mean and SD were not significantly influenced by the covariates tested. Only Hb SD was significantly lower in maintenance studies relative to correction studies. No differences in mean ESA dose and CV were found across the covariates, except that PEG-EPO monthly dose was 42% higher than the every 2 weeks dose and the rHuEPO i.v. dose was 32% higher than the s.c. dose.


CONCLUSIONS
Between subject variability in haemoglobin and ESA dose in dialysis patients is not associated with the type of ESA, nor with the dosing interval or route of administration, except for higher dose requirements in PEG-EPO monthly administration relative to every 2 weeks or rHuEPO i.v. relative to s.c.
Pharmacokinetics & Drug Metabolism, Amgen Inc., Picayo, 3, ES-46530, Puzol (Valencia), Spain. juanjose@amgen.com
Juan José
JJ
Pérez-Ruixo
Mercedes
M
Cucala-Ramos
Ester
E
García-Gonzalo
Beatriz
B
Del Val Romero
Neus
N
Valveny
D000328:Adult; D000740:Anemia / Q000097:blood / Q000188:drug therapy*; D006397:Hematinics / Q000008:administration & dosage*; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D006435:Renal Dialysis / Q000009:adverse effects*
D006397:Hematinics; D006454:Hemoglobins