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Safety and Effectiveness of an Accelerated Intravenous Iron Administration Protocol in Hospitalized Patients With
Ifeoma Mary Eche1, Kathryn L Owen2, Ijeoma Julie Eche3
1Department of Pharmacy, 1859Beth Israel Deaconess Medical Center, Boston, MA, USA.
Insights
Intravenous (IV) iron replacement using sodium ferric gluconate complex (SFGC) in hospitalized heart failure (HF) patients is safe and effective. This IV iron therapy showed a low incidence of adverse events and similar readmission rates compared to controls.
Area of Science:
- Cardiology
- Pharmacology
- Internal Medicine
Background:
- The ACC/AHA heart failure (HF) guidelines recommend intravenous (IV) iron for patients with iron deficiency and NYHA class II or III HF to enhance functional status.
- While studies exist on ferric carboxymaltose and iron sucrose, research on sodium ferric gluconate complex (SFGC) in HF populations is limited.
Purpose of the Study:
- To evaluate the safety and effectiveness of an IV SFGC administration protocol for hospitalized heart failure patients.
- To assess adverse reactions and heart failure readmission rates associated with IV SFGC.
Main Methods:
- A retrospective cohort study included 123 patients admitted to a heart failure service between September 2017 and March 2018.
- The study compared adverse events and HF readmission rates between patients receiving IV SFGC and a control group not receiving IV iron.
Main Results:
- Seven percent of patients receiving IV SFGC experienced adverse events, including hypotension, fever, and myalgia.
- HF readmission rates at 30 days (12.8% vs. 9.4%) and 6 months (25.7% vs. 26.4%) were similar between the IV SFGC and control groups.
Conclusions:
- Sodium ferric gluconate complex administered on an accelerated schedule is a safe and efficient option for inpatient IV iron therapy.
- The low frequency of adverse events and comparable readmission rates support the use of IV SFGC in hospitalized HF patients.
Background:
The ACC/AHA heart failure (HF) guidelines include a class IIb recommendation for intravenous (IV) iron replacement in patients with iron deficiency and New York Heart Association class II or III to improve functional status and quality of life. Several studies have addressed the use of IV iron formulations such as ferric carboxymaltose or iron sucrose in HF population; however, few studies focused on sodium ferric gluconate complex (SFGC).
Objectives:
To assess the safety and effectiveness of an IV SFGC administration protocol in patients hospitalized with HF.
Methods:
A retrospective cohort study was conducted. We included patients admitted to the HF service from September 2017 to March 2018. The primary outcome was the frequency of adverse reactions. The secondary outcome was the odds of HF readmissions between the 2 groups (IV SFGC vs. control).
Results:
Of the 123 patients, 70 received IV iron (SFGC group) and 53 did not receive IV iron (control group). Five (7%) patients of the 70 in the SFGC group experienced adverse events, which included hypotension (n = 2, 2.8%), fever (n = 2, 2.8%) and myalgia (n = 2, 2.8%). Nine (12.8%) and 18 (25.7%) were readmitted within 30 days and 6 months respectively. In the control arm, 5 (9.4%) and 14 (26.4%) were admitted within 30 days and 6 months respectively. The odds of HF readmission at 30 days [OR 1.4 (95% CI: 0.45, 4.5)] and at 6 months [OR 0.96 (95% CI: 0.43, 2.2)] were similar in those who did not receive IV iron compared to those who received IV iron.
Conclusions:
Sodium ferric gluconate complex given at an accelerated dosing schedule appears to provide a more efficient means to prescribe IV iron in the inpatient setting and is safe with a low frequency of hypotension, fevers, and myalgias.
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