Efficacy and Safety of Treatment With Ferric Carboxymaltose in Patients With Cirrhosis and Gastrointestinal Bleeding.

Background: Patients with liver cirrhosis and gastrointestinal bleeding (GIB) often develop anemia. Ferric carboxymaltose (FCM) is an intravenous (i.v.) iron formulation approved for use in patients with iron deficiency with inadequate response to oral iron therapy or when oral iron cannot be used. Here we analyzed the efficacy and safety of FCM treatment in cirrhotic patients with anemia and GIB. Methods: Retrospective observational study of patients with cirrhosis and acute or chronic GIB treated with 1,000 mg FCM at the University Hospital Arnau de Vilanova (Lleida, Spain) that follows a restrictive-transfusion strategy. All data were obtained from the patients' medical records. We used the Wilcoxon test to evaluate statistical significance. Results: Patients with cirrhosis and GIB (n = 34) were treated with 1,000 mg FCM. Portal hypertension were present in 88.2% of the patients. For hospitalized patients (n = 21), median serum hemoglobin (s-Hb) levels increased by 3.0 g/dL (p < 0.02) and 3.9 g/dL (p < 0.07) for patients treated with FCM who had or had not received also a transfusion, respectively, compared to levels recorded upon admission. For outpatients (n = 13) the mean s-Hb levels was 9.8 ± 1.6 g/dL before FCM treatment and 11.3 ± 2.1 g/dL after treatment, demonstrating a mean increase of 1.5 g/dL (p < 0.001). No serious adverse reactions to FCM were observed. Conclusion: FCM administration achieved optimal s-Hb levels in most cirrhotic patients with acute or chronic GIB, suggesting that early FCM infusion improves and maintains optimal s-Hb levels in these patients and may be an appropriate first-line therapy to treat their anemia.

Clinical experience with ferric carboxymaltose in the management of anemia in acute gastrointestinal bleeding.

OBJECTIVE: The aim of this study was to assess the efficacy and safety of intravenous ferric carboxymaltose (FCM) following hospitalization for acute gastrointestinal bleeding (AGIB) in the context of a restrictive transfusion strategy. PATIENTS AND METHODS: A retrospective single-center study analyzed patients with AGIB (excluding AGIB secondary to portal hypertension) administered a single FCM dose with or without blood transfusion. RESULTS: Eighty-six episodes in 84 patients were analyzed. Seventy-nine patients had upper AGIB. Nineteen episodes were associated with hemodynamic instability. FCM was administered during hospitalization as a single dose of 1000 mg iron in 84/86 episodes and as a single dose of 500 mg iron in two episodes, with blood transfusion in 60/86 (69.8%) episodes. The mean hemoglobin (Hb) was 9.0 g/dl at admission, 7.6 g/dl at the lowest in-hospital value, 9.4 g/dl at discharge, and 12.7 g/dl at follow-up (mean: 55 days postdischarge) (P<0.001 for follow-up vs. all other timepoints). The lowest mean in-hospital Hb value was 7.2 and 8.8 g/dl, respectively, in patients with transfusion+FCM versus FCM alone; the mean Hb was 12.4 versus 13.7 g/dl at follow-up. In patients administered FCM alone, the mean Hb at follow-up in the subpopulations aged older than or equal to 75 years (n=33), Charlson comorbidity index of at least 3 (n=48), and Hb of up to 10 g/dl at admission (n=47) were 12.6, 13.1, and 13.3 g/dl, respectively. No adverse effects were detected. CONCLUSION: Treatment with FCM for AGIB is associated with a good erythropoietic response and anemia correction after hospitalization, even in severe episodes or when transfusion is needed. FCM is safe and well tolerated, and may support a restrictive transfusion policy.

Between subjects variability in haemoglobin and dose are not associated with the erythropoiesis-stimulating agent used to treat anaemia in dialysis: a meta-analysis.

AIMS: 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.