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Treatment of Iron Deficiency with or without Anaemia with Intravenous Ferric Carboxymaltose in Gynaecological Practices - A Non-Interventional Study.

ABSTRACT: In this multi-centre, prospective, non-interventional study, the effectiveness and tolerance of ferric carboxymaltose (ferinject®; FCM) was tested through use in standard gynaecological practice. In total, data from 273 patients was evaluated. 193 of these patients displayed iron deficiency anaemia (IDA), and 68 had iron deficiency without anaemia (ID). The reasons for the ID/IDA were hypermenorrhoea (HyM) (n?=?170), post-partum condition (PP) (n?=?53) or another indication (n?=?53). The average age of the patients was 40 years old, with 8?% of them being vegetarians. Half of the patients had already been treated for anaemia, primarily with oral iron products (94?%). The primary, serious accompanying symptoms of anaemia were fatigue (72?%), lack of concentration (42?%), pale mucous membranes (42?%), headache (26?%) and sleep disorders (21?%). Only one patient did not show serious symptoms at the start of the study. The most frequent indications for parenteral therapy were the need for rapid iron substitution to reduce symptoms (>?70?%), followed by the lower effectiveness or intolerance of oral products (42?% each) as well as patients not completing the course of treatment with oral products (12?%). Patient information was collected at both the beginning and the end of the observation period, which lasted 15 weeks on average. FCM was most frequently administered via infusion (92?%; average infusion duration 21 minutes). Seven percent of patients received bolus injections. The average total iron dosage per patient was 788.7?mg (median 550?mg; range: 50-3000?mg); the median individual dosage was 500?mg (range: 50-1000?mg). The total dosage was, in most cases, administered through a single application (range: 1-10). Symptoms, blood values (Hb), iron stores (serum-ferritin [S-ferritin]) and transport iron (transferrin saturation [TSAT]) normalised to a large extent. In all subgroups, 92?% of women displayed a marked improvement in all of their symptoms. The average increase in Hb-value in the group as a whole was statistically significant, increasing from 10.5 to 13.0?g/dl. In the group with anaemia, the value increased from 9.9 to 13.3?g/dl, with 80?% of women reaching normal Hb-values. The average S-ferritin value increased by a statistically significant >?70?µg/L from 17.2 to 88.8?µg/l and the value for the TSAT increased from 16.3?% to 22.8?%. Seven patients reported experiencing side effects. None of the results were severe. Overall, as part of this non-interventional study for everyday routine in a gynaecological practice, a rapid improvement in symptoms accompanied by the rectification of iron deficiency and anaemia was shown with low occurrences of mild undesirable events, and therefore the data obtained from controlled clinical studies on the effectiveness and tolerance of intravenous ferric carboxymaltose could be confirmed.

SUBMITTER: Herfs R

PROVIDER: S-EPMC3964352 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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Treatment of Iron Deficiency with or without Anaemia with Intravenous Ferric Carboxymaltose in Gynaecological Practices - A Non-Interventional Study.

Herfs R R Fleitmann L L Kocsis I I

Geburtshilfe und Frauenheilkunde 20140101 1

In this multi-centre, prospective, non-interventional study, the effectiveness and tolerance of ferric carboxymaltose (ferinject®; FCM) was tested through use in standard gynaecological practice. In total, data from 273 patients was evaluated. 193 of these patients displayed iron deficiency anaemia (IDA), and 68 had iron deficiency without anaemia (ID). The reasons for the ID/IDA were hypermenorrhoea (HyM) (n = 170), post-partum condition (PP) (n = 53) or another indication (n = 53). The average ...[more]

PMID: 24741123

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Project description:BackgroundIron deficiency anaemia (IDA) is a major health issues and common type of nutritional deficiency worldwide. For IDA treatment, intravenous (IV) iron is a useful therapy.ObjectiveTo determine the efficacy and cost-effectiveness (CE) of intravenous (IV) Ferric Carboxymaltose (FCM) versus IV Iron Sucrose (IS) in treating IDA.Data sourcesElectronic medical record i.e. Cerner® system.Target populationAdults patients with iron deficiency anaemia.Time horizonA 12-month period (01/01/2018-31/12/2018).PerspectiveHamad Medical Corporation (HMC, a public hospital).InterventionIV Ferric Carboxymaltose versus IV Iron Sucrose.Outcome measuresWith regard to responses to treatment i.e., efficacy of treatment with FCM & IS in IDA patients, hemoglobin (Hgb), ferritin, and transferrin saturation (TSAT) levels were the primary outcomes. Additionally, the researchers also collected levels of iron, platelet, white blood cell (WBC), red blood cell (RBC), mean corpuscular hemoglobin (MCH), and mean corpuscular volume (MCV). The costs i.e. resources consumed (obtained from NCCCR-HMC) and the CE of FCM versus IS were the secondary outcomes.Results of base-case analysisThere was a significant improvement in Hgb, RBC and MCH levels in the IS group than the FCM group. The overall cost of IS therapy was significantly higher than FCM. The medication cost for FCM was approximately 6.5 times higher than IS, nonetheless, it is cheaper in terms of bed cost and nursing cost. The cost effectiveness (CE) ratio illustrated that FCM and IS were significantly different in terms of Hgb, ferritin and MCH levels. Further, Incremental Cost Effectiveness Ratio (ICER) indicated that further justifications and decisions need to be made for FCM when using Hgb, iron, TSAT, MCH and MCV levels as surrogate outcomes.Results of sensitivity analysisNot applicable.LimitationsThe study did not consider the clinical or humanistic outcome.ConclusionsThe higher cost of FCM versus IS can be offset by savings in healthcare personnel time and bed space. ICER indicated that further justifications and decisions need to be made for FCM when using Hgb, iron, TSAT, MCH and MCV levels as surrogate outcomes.

Project description:BackgroundIron deficiency is the primary cause of anemia in children. Intravenous (IV) iron formulations circumvent malabsorption and rapidly restore hemoglobin.MethodsThis Phase 2, non-randomized, multicenter study characterized the safety profile and determined appropriate dosing of ferric carboxymaltose (FCM) in children with iron deficiency anemia. Patients aged 1-17 years with hemoglobin <11 g/dL and transferrin saturation <20% received single IV doses of undiluted FCM 7.5 mg/kg (n = 16) or 15 mg/kg (n = 19).ResultsThe most common drug-related treatment-emergent adverse event was urticaria (in three recipients of FCM 15 mg/kg). Systemic exposure to iron increased in a dose-proportional manner with approximate doubling of mean baseline-corrected maximum serum iron concentration (157 µg/mL with FCM 7.5 mg/kg; and 310 µg/mL with FCM 15 mg/kg) and area under the serum concentration-time curve (1901 and 4851 h·µg/mL, respectively). Baseline hemoglobin was 9.2 and 9.5 g/dL in the FCM 7.5 and 15 mg/kg groups, respectively, with mean maximum changes in hemoglobin of 2.2 and 3.0 g/dL, respectively.ConclusionsIn conclusion, FCM was well tolerated by pediatric patients. Improvements in hemoglobin were greater with the higher dose, supporting use of the FCM 15 mg/kg dose in pediatric patients (Clinicaltrials.gov NCT02410213).ImpactThis study provided information on the pharmacokinetics and safety of intravenous ferric carboxymaltose for treatment of iron deficiency anemia in children and adolescents. In children aged 1-17 years with iron deficiency anemia, single intravenous doses of ferric carboxymaltose 7.5 or 15 mg/kg increased systemic exposure to iron in a dose-proportional manner, with clinically meaningful increases in hemoglobin. The most common drug-related treatment-emergent adverse event was urticaria. The findings suggest that iron deficiency anemia in children can be corrected with a single intravenous dose of ferric carboxymaltose and support use of a 15 mg/kg dose.

Project description:AimThe aim of this study was to evaluate the benefits and safety of long-term i.v. iron therapy in iron-deficient patients with heart failure (HF).Methods and resultsCONFIRM-HF was a multi-centre, double-blind, placebo-controlled trial that enrolled 304 ambulatory symptomatic HF patients with left ventricular ejection fraction ≤45%, elevated natriuretic peptides, and iron deficiency (ferritin <100 ng/mL or 100-300 ng/mL if transferrin saturation <20%). Patients were randomized 1 : 1 to treatment with i.v. iron, as ferric carboxymaltose (FCM, n = 152) or placebo (saline, n = 152) for 52 weeks. The primary end-point was the change in 6-min-walk-test (6MWT) distance from baseline to Week 24. Secondary end-points included changes in New York Heart Association (NYHA) class, Patient Global Assessment (PGA), 6MWT distance, health-related quality of life (QoL), Fatigue Score at Weeks 6, 12, 24, 36, and 52 and the effect of FCM on the rate of hospitalization for worsening HF. Treatment with FCM significantly prolonged 6MWT distance at Week 24 (difference FCM vs. placebo: 33 ± 11 m, P = 0.002). The treatment effect of FCM was consistent in all subgroups and was sustained to Week 52 (difference FCM vs. placebo: 36 ± 11 m, P < 0.001). Throughout the study, an improvement in NYHA class, PGA, QoL, and Fatigue Score in patients treated with FCM was detected with statistical significance observed from Week 24 onwards. Treatment with FCM was associated with a significant reduction in the risk of hospitalizations for worsening HF [hazard ratio (95% confidence interval): 0.39 (0.19-0.82), P = 0.009]. The number of deaths (FCM: 12, placebo: 14 deaths) and the incidence of adverse events were comparable between both groups.ConclusionTreatment of symptomatic, iron-deficient HF patients with FCM over a 1-year period resulted in sustainable improvement in functional capacity, symptoms, and QoL and may be associated with risk reduction of hospitalization for worsening HF (ClinicalTrials.gov number NCT01453608).

Dataset Information

Treatment of Iron Deficiency with or without Anaemia with Intravenous Ferric Carboxymaltose in Gynaecological Practices - A Non-Interventional Study.

Publications

Treatment of Iron Deficiency with or without Anaemia with Intravenous Ferric Carboxymaltose in Gynaecological Practices - A Non-Interventional Study.

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