Background and Objective <p> Moderate-to-severe iron deficiency anemia (IDA) is frequently treated using parenteral iron preparations, such as ferric carboxymaltose (FCM). In India, there is a dearth of empirical data about the safety and effectiveness of FCM in treating chronic kidney disease (CKD). Hence, this study aims to provide data regarding safety and efficacy of FCM in CKD patients suffering from anemia. The data will help in providing evidences for larger trials. </p> Methods <p> It was a retrospective, multicentre and observational study conducted to assess the efficacy and safety of FCM in adults with CKD stages 3-5D, diagnosed with anemia (Hb &lt;12 g/dL for women and &lt;13 g/dL for men) and treated with at least one dose of intravenous FCM. In this study, retrospective data were captured from ten centers across India (hospitals, clinics and health care institutes). The data were analyzed for hematological parameters at baseline, 4, 8 and after 12 weeks for evaluating the efficacy of FCM. </p> Results <p> Data from 101 patients were evaluated. Mean (SD) age of the patients was 52 (13.73) years and sixty two percent of them were male. Around twenty one percent suffered from hypertension while eighteen percent patients were diabetic. Eighty five percent of the patients were receiving erythropoiesis-stimulating agents [ESAs ] for anemia correction. Intravenous FCM increased haemoglobin (Hb) by 1.5 g/dL, serum ferritin by 29 ng/ml, and transferrin saturation (TSAT) by 4.52% twelve weeks after baseline in IDA patients.</p> Conclusions <p>Intravenous FCM was efficacious in increasing the hemoglobin and improving the TSAT and serum Ferritin level with no major side effects reported. More data should be generated in real world practice regarding FCM usage in renal anemia with iron deficiency.</p> Trial Registration Number <p>INT/Viva/2425/01–01.</p>

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Real-World Multicentre Retrospective Study in Indian Patients on the Effectiveness and Safety of Ferric Carboxymaltose in Renal Anemia (HaemOxy)

  • Tanmay Pandya,
  • Adyapad Pani,
  • Pradeep Kumar,
  • Vijay Shankar,
  • Kanai Lal Karmakar,
  • Anjan Barkataky,
  • Luvdeep Dogra,
  • Vidyanand Tripathi,
  • Mohammed Shoeb Ahmed Khan,
  • Ashvinikumar Khandekar,
  • Deepak Bunger,
  • Jay Kumar Sharma

摘要

Background and Objective

Moderate-to-severe iron deficiency anemia (IDA) is frequently treated using parenteral iron preparations, such as ferric carboxymaltose (FCM). In India, there is a dearth of empirical data about the safety and effectiveness of FCM in treating chronic kidney disease (CKD). Hence, this study aims to provide data regarding safety and efficacy of FCM in CKD patients suffering from anemia. The data will help in providing evidences for larger trials.

Methods

It was a retrospective, multicentre and observational study conducted to assess the efficacy and safety of FCM in adults with CKD stages 3-5D, diagnosed with anemia (Hb <12 g/dL for women and <13 g/dL for men) and treated with at least one dose of intravenous FCM. In this study, retrospective data were captured from ten centers across India (hospitals, clinics and health care institutes). The data were analyzed for hematological parameters at baseline, 4, 8 and after 12 weeks for evaluating the efficacy of FCM.

Results

Data from 101 patients were evaluated. Mean (SD) age of the patients was 52 (13.73) years and sixty two percent of them were male. Around twenty one percent suffered from hypertension while eighteen percent patients were diabetic. Eighty five percent of the patients were receiving erythropoiesis-stimulating agents [ESAs ] for anemia correction. Intravenous FCM increased haemoglobin (Hb) by 1.5 g/dL, serum ferritin by 29 ng/ml, and transferrin saturation (TSAT) by 4.52% twelve weeks after baseline in IDA patients.

Conclusions

Intravenous FCM was efficacious in increasing the hemoglobin and improving the TSAT and serum Ferritin level with no major side effects reported. More data should be generated in real world practice regarding FCM usage in renal anemia with iron deficiency.

Trial Registration Number

INT/Viva/2425/01–01.