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The safety and efficacy of high dose ferric carboxymaltose in patients with chronic kidney disease: A single center study.

Vikrant S, Parashar A - Indian J Nephrol (2015 Jul-Aug)

Bottom Line: All patients had a successful administration of the FCM.We conclude high dose administration of FCM is safe and well-tolerated.It was effective in the treatment of iron deficiency in nondialysis and peritoneal dialysis CKD patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Nephrology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India.

ABSTRACT
Ferric carboxymaltose (FCM) is a parenteral, dextran-free iron formulation designed to overcome the limitations of existing intravenous (IV) iron preparations. We investigated the safety and efficacy of high dose administration of FCM in our anemic chronic kidney disease (CKD) patients. It was a prospective observational study from June 2011 to August 2013. FCM was administered as IV infusion 1000 mg in 250 ml of normal saline over 15-30 min. Efficacy was evaluated by comparing the Hb and/or serum iron status at the first follow-up visit after the infusion with that at the baseline. A total of 500 infusions were administered to 450 patients. All patients had a successful administration of the FCM. None of the patients had any serious drug-related AE. AE of mild to moderate severity observed or reported after the infusion were: accelerated hypertension (0.2%), feeling abnormal (0.6%), headache and bodyaches (0.6% each), and infusion site reaction (0.8%). 261 patients had a follow up Hb, which showed an increase of 1.7 ± 1.5 g/dl after a period of 11 ± 7.2 weeks (P = 0.001); 188 (72%) patients had a rise in Hb of ≥1 g/dl. The increase in Hb was observed uniformly across all stages of CKD. Proportions of patients with an Hb of above 10 and 11 g/dl increased from 30.2% to 62.8% and 16.1% to 37.9%, respectively (P = 0.001). Iron status evaluation done in 44 patients after a follow up period of 15.1 ± 11.5 weeks showed increases in Hb of 1.6 ± 2.2 g/dl (P = 0.001), transferrin saturation of 9.1 ± 16.9% (P = 0.001), and ferritin of 406 ± 449 ng/ml (P = 0.001). We conclude high dose administration of FCM is safe and well-tolerated. It was effective in the treatment of iron deficiency in nondialysis and peritoneal dialysis CKD patients.

No MeSH data available.


Related in: MedlinePlus

Mean changes from baseline to follow up for Hb. The paired samples T-test was done to compare the mean changes in Hb. *indicates significant difference from baseline, P = 0.001
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Figure 1: Mean changes from baseline to follow up for Hb. The paired samples T-test was done to compare the mean changes in Hb. *indicates significant difference from baseline, P = 0.001

Mentions: Two hundred and sixty-one patients had a follow up Hb [Table 4 and Figure 1]. There was a significant increase in the mean Hb after a period of 11 ± 7.2 weeks. The Hb increased from a baseline of 9.1 ± 2.1 g/dl to 10.7 ± 2 g/dl showing an increase of 1.7 ± 1.5 g/dl (95% CI, 1.5-1.9, P = 0.001). This significant increase in Hb was uniformly seen across all stages of CKD. In stage 3 CKD patients, the Hb increased from 9.8 ± 2.2 g/dl to 11.6 ± 2 g/dl showing an increase of 1.8 ± 1.4 g/dl (95% CI, 1.5-2.1, P = 0.001). In stage 4 CKD patients, the Hb increased from 9.6 ± 1.8 g/dl to 11.1 ± 1.9 g/dl showing an increase of 1.5 ± 1.6 g/dl (95% CI 1.2-1.9, P = 0.001). In stage 5 CKD patients, the Hb increased from 8.2 ± 2 g/dl to 10 ± 1.9 g/dl showing an increase of 1.7 ± 1.6 g/dl (95% CI, 1.4-2.1, P = 0.001). In stage 5D CKD patients (17 PD-CKD and two HD-CKD), the Hb increased from 8.3 ± 1.6 g/dl to 9.7 ± 1 g/dl showing an increase of 1.4 ± 1.4 g/dl (95% CI, 0.7-2.1, P = 0.001). In HD-CKD patients, the Hb increased from baseline Hb of 8.6 ± 0.6 g/dl to 9.7 ± 1.1 g/dl showing an increase of 1.2 ± 0.5 g/dl (95% CI,-3.2-5.6, P = 0.188). Sixty-one (48.4%) out of a total of 126 patients with elevated CRP levels had a follow up Hb, which was a significant rise. The Hb increased from a baseline of 9.1 ± 2.3 g/dl to 11 ± 2.1 g/dl showing an increase of 1.8 ± 1.3 g/dl (95% CI, 1.5-2.2, P = 0.001). Two hundred and one (77%) patients were getting ESA, 70 (35%) were on stable doses before and during the study and in others, the initial dose was maintained during the study. The rise in Hb was significant in both subset of patients with ESA at baseline and those with ESA initiated after FCM infusion (P = 0.001). Even the patients not on ESA had a significant rise in their Hb levels (P = 0.001).


The safety and efficacy of high dose ferric carboxymaltose in patients with chronic kidney disease: A single center study.

Vikrant S, Parashar A - Indian J Nephrol (2015 Jul-Aug)

Mean changes from baseline to follow up for Hb. The paired samples T-test was done to compare the mean changes in Hb. *indicates significant difference from baseline, P = 0.001
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4495475&req=5

Figure 1: Mean changes from baseline to follow up for Hb. The paired samples T-test was done to compare the mean changes in Hb. *indicates significant difference from baseline, P = 0.001
Mentions: Two hundred and sixty-one patients had a follow up Hb [Table 4 and Figure 1]. There was a significant increase in the mean Hb after a period of 11 ± 7.2 weeks. The Hb increased from a baseline of 9.1 ± 2.1 g/dl to 10.7 ± 2 g/dl showing an increase of 1.7 ± 1.5 g/dl (95% CI, 1.5-1.9, P = 0.001). This significant increase in Hb was uniformly seen across all stages of CKD. In stage 3 CKD patients, the Hb increased from 9.8 ± 2.2 g/dl to 11.6 ± 2 g/dl showing an increase of 1.8 ± 1.4 g/dl (95% CI, 1.5-2.1, P = 0.001). In stage 4 CKD patients, the Hb increased from 9.6 ± 1.8 g/dl to 11.1 ± 1.9 g/dl showing an increase of 1.5 ± 1.6 g/dl (95% CI 1.2-1.9, P = 0.001). In stage 5 CKD patients, the Hb increased from 8.2 ± 2 g/dl to 10 ± 1.9 g/dl showing an increase of 1.7 ± 1.6 g/dl (95% CI, 1.4-2.1, P = 0.001). In stage 5D CKD patients (17 PD-CKD and two HD-CKD), the Hb increased from 8.3 ± 1.6 g/dl to 9.7 ± 1 g/dl showing an increase of 1.4 ± 1.4 g/dl (95% CI, 0.7-2.1, P = 0.001). In HD-CKD patients, the Hb increased from baseline Hb of 8.6 ± 0.6 g/dl to 9.7 ± 1.1 g/dl showing an increase of 1.2 ± 0.5 g/dl (95% CI,-3.2-5.6, P = 0.188). Sixty-one (48.4%) out of a total of 126 patients with elevated CRP levels had a follow up Hb, which was a significant rise. The Hb increased from a baseline of 9.1 ± 2.3 g/dl to 11 ± 2.1 g/dl showing an increase of 1.8 ± 1.3 g/dl (95% CI, 1.5-2.2, P = 0.001). Two hundred and one (77%) patients were getting ESA, 70 (35%) were on stable doses before and during the study and in others, the initial dose was maintained during the study. The rise in Hb was significant in both subset of patients with ESA at baseline and those with ESA initiated after FCM infusion (P = 0.001). Even the patients not on ESA had a significant rise in their Hb levels (P = 0.001).

Bottom Line: All patients had a successful administration of the FCM.We conclude high dose administration of FCM is safe and well-tolerated.It was effective in the treatment of iron deficiency in nondialysis and peritoneal dialysis CKD patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Nephrology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India.

ABSTRACT
Ferric carboxymaltose (FCM) is a parenteral, dextran-free iron formulation designed to overcome the limitations of existing intravenous (IV) iron preparations. We investigated the safety and efficacy of high dose administration of FCM in our anemic chronic kidney disease (CKD) patients. It was a prospective observational study from June 2011 to August 2013. FCM was administered as IV infusion 1000 mg in 250 ml of normal saline over 15-30 min. Efficacy was evaluated by comparing the Hb and/or serum iron status at the first follow-up visit after the infusion with that at the baseline. A total of 500 infusions were administered to 450 patients. All patients had a successful administration of the FCM. None of the patients had any serious drug-related AE. AE of mild to moderate severity observed or reported after the infusion were: accelerated hypertension (0.2%), feeling abnormal (0.6%), headache and bodyaches (0.6% each), and infusion site reaction (0.8%). 261 patients had a follow up Hb, which showed an increase of 1.7 ± 1.5 g/dl after a period of 11 ± 7.2 weeks (P = 0.001); 188 (72%) patients had a rise in Hb of ≥1 g/dl. The increase in Hb was observed uniformly across all stages of CKD. Proportions of patients with an Hb of above 10 and 11 g/dl increased from 30.2% to 62.8% and 16.1% to 37.9%, respectively (P = 0.001). Iron status evaluation done in 44 patients after a follow up period of 15.1 ± 11.5 weeks showed increases in Hb of 1.6 ± 2.2 g/dl (P = 0.001), transferrin saturation of 9.1 ± 16.9% (P = 0.001), and ferritin of 406 ± 449 ng/ml (P = 0.001). We conclude high dose administration of FCM is safe and well-tolerated. It was effective in the treatment of iron deficiency in nondialysis and peritoneal dialysis CKD patients.

No MeSH data available.


Related in: MedlinePlus