Ferric carboxymaltose 100mg/2ml dispersion for injection vials

Introduction Restless Legs Syndrome (RLS), also known as Willis-Ekbom Disease (WED), is a sensorimotor disorder characterized by an uncontrollable urge to move the legs, typically accompanied by discomfort. Low iron levels, pregnancy, and age are some identified risk factors. RLS is treated using various pharmacological options, including dopamine agonists, benzodiazepines, anticonvulsants, opioids, and bupropion. Iron supplementation, particularly with intravenous Ferric carboxymaltose (FCM), has gained attention due to the role of iron deficiency in RLS pathophysiology. This meta-analysis evaluates the efficacy and safety of FCM in treating RLS symptoms. Materials and methods A systematic review and meta-analysis were conducted following the PRISMA guidelines, using databases such as PubMed, Google Scholar, and Cochrane. Studies involving intravenous FCM in patients diagnosed with RLS were included. Statistical analysis was performed using Review Manager 5.4. Results Seven studies involving 539 participants were analyzed. FCM significantly reduced IRLS scores (WMD = −5.77; 95% CI = [−8.85, −2.70]; p = 0.0002) and improved VAS and SF-36 scores compared to placebo. However, FCM did not significantly improve RLS quality of life scores. Adverse events were more common in the FCM group, particularly nausea, but no significant differences were found for severe adverse events. Conclusion In conclusion, intravenous ferric carboxymaltose significantly reduces Restless Legs Syndrome symptoms, especially in patients with confirmed iron deficiency. The treatment appears generally well-tolerated, with adverse effects being manageable. However, further long-term studies are needed to fully assess the safety profile and confirm sustained symptom improvement in a broader population. Systematic review registration https://www.crd.york.ac.uk/prospero/, identifier: CRD42024585233.

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Background: Iron deficiency (ID) often coexists with heart failure (HF), and its prevalence increases with the severity of HF. Intravenous ferric carboxymaltose (FCM) has been associated with improvements in clinical outcomes, functional capacity, and quality of life (QoL) in patients with HF and ID. However, while earlier studies showed favorable results, more recent studies have failed to demonstrate significant improvements in outcomes for patients with heart failure with reduced ejection fraction (HFrEF) and ID. This meta-analysis seeks to provide updated insights into the effectiveness and safety of FCM compared to placebo/standard of care (SoC) among patients with HFrEF and ID/iron deficiency anemia (IDA). Methods: We performed a systematic review and meta-analysis of the literature from inception to December 2023, utilizing databases such as MEDLINE (via PubMed), Google Scholar, the Cochrane Library, ClinicalTrials.gov, and the ScienceDirect portal. A statistical analysis was carried out using RevMan 5.4 with a random-effects model. Dichotomous outcomes were reported as odds ratios (OR), while continuous outcomes were presented as the weighted mean difference (WMD) with corresponding 95% confidence intervals (CI), and heterogeneity was assessed using the I2 test. Results: The final analysis included data from six randomized controlled trials (RCTs), comprising 5132 patients. Our findings indicate a significant reduction in total HF hospitalizations among patients with HFrEF and ID/IDA treated with FCM compared to those receiving the placebo or SoC, with an OR of 0.59 (95% CI: 0.40 to 0.88, p p = 0.09), non-HF hospitalizations (OR: 0.71; 95% CI: 0.41 to 1.25, p = 0.24), or the composite outcome of cardiovascular hospitalizations and cardiovascular deaths (OR: 0.65; 95% CI: 0.40 to 1.04, p = 0.07). Regarding functional capacity, as assessed by the change in 6-min walk test (6MWT) distance, no significant improvement was found, with a weighted mean difference (WMD) of 14.03 (95% CI: -10.94 to 38.99, p = 0.27). QoL, measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score, also did not show significant enhancement, with a WMD of 3.85 (95% CI: -0.55 to 8.24, p = 0.09). Furthermore, the safety analysis revealed no significant difference in the incidence of serious adverse events between the FCM and placebo/SoC groups, with an OR of 0.73 (95% CI: 0.49 to 1.10, p = 0.13). Conclusions: In patients with HFrEF and IDA, treatment with intravenous FCM significantly lowers the risk of total HF hospitalizations but does not appear to affect functional capacity, QoL, or mortality.

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