Dataset Information

A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ferric Carboxymaltose in Iron-Deficient Patients with Fibromyalgia.

ABSTRACT: INTRODUCTION:This study sought to compare efficacy and safety of ferric carboxymaltose vs. placebo in iron-deficient patients with fibromyalgia. METHODS:This blinded, placebo-controlled, phase 2 study randomized adults with fibromyalgia and Revised Fibromyalgia Impact Questionnaire (FIQR) scores ? 60, ferritin levels < 0.05 µg/ml, and transferrin saturation < 20% (1:1) to receive ferric carboxymaltose [15 mg/kg (up to 750 mg)], or placebo (15 cc normal saline) intravenously on study days 0 and 5. Patients visited the clinic on days 14, 28, and 42 for efficacy and safety assessments. The primary efficacy endpoint was proportion of patients with a ? 13-point improvement from baseline to day 42 in FIQR scale score. Secondary endpoints included changes from baseline in FIQR scale, Brief Pain Inventory (BPI) total score, Medical Outcomes Study (MOS) Sleep scale, Fatigue Visual Numeric Scale (VNS), iron indices (transferrin saturation and ferritin), and safety. RESULTS:The efficacy analysis group comprised 80 patients, and the safety analysis group comprised 81. More ferric carboxymaltose patients (77%) vs. placebo patients (67%) achieved the primary endpoint, but the difference was not significant. Greater improvements from baseline to day 42 were observed for ferric carboxymaltose vs. placebo in FIQR total score, BPI total score, Fatigue VNS score, and iron indices. Mean changes in MOS Sleep scale scores were similar between groups. Ferric carboxymaltose was safe and well tolerated. CONCLUSIONS:Compared with placebo, ferric carboxymaltose improved measures of fibromyalgia severity and was well tolerated. The current results suggest that ferric carboxymaltose shows benefit in iron-deficient patients with concurrent fibromyalgia. FUNDING:Luitpold Pharmaceuticals, Inc. TRIAL REGISTRATION:ClinicalTrials.gov identifier, NCT02409459.

SUBMITTER: Boomershine CS

PROVIDER: S-EPMC5935608 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ferric Carboxymaltose in Iron-Deficient Patients with Fibromyalgia.

Boomershine Chad S CS Koch Todd A TA Morris David D

Rheumatology and therapy 20171117 1

<h4>Introduction</h4>This study sought to compare efficacy and safety of ferric carboxymaltose vs. placebo in iron-deficient patients with fibromyalgia.<h4>Methods</h4>This blinded, placebo-controlled, phase 2 study randomized adults with fibromyalgia and Revised Fibromyalgia Impact Questionnaire (FIQR) scores ≥ 60, ferritin levels < 0.05 µg/ml, and transferrin saturation < 20% (1:1) to receive ferric carboxymaltose [15 mg/kg (up to 750 mg)], or placebo (15 cc normal saline) intravenously on stu ...[more]

PMID: 29149437

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Project description:BackgroundUnexplained fatigue is often left untreated or treated with antidepressants. This randomized, placebo-controlled, single-blinded study evaluated the efficacy and tolerability of single-dose intravenous ferric carboxymaltose (FCM) in iron-deficient, premenopausal women with symptomatic, unexplained fatigue.MethodsFatigued women (Piper Fatigue Scale [PFS] score ≥5) with iron deficiency (ferritin <50 µg/L and transferrin saturation <20%, or ferritin <15 µg/L) and normal or borderline hemoglobin (≥115 g/L) were enrolled in 21 sites in Austria, Germany, Sweden and Switzerland, blinded to the study drug and randomized (computer-generated randomization sequence) to a single FCM (1000 mg iron) or saline (placebo) infusion. Primary endpoint was the proportion of patients with reduced fatigue (≥1 point decrease in PFS score from baseline to Day 56).ResultsThe full analysis included 290 women (FCM 144, placebo 146). Fatigue was reduced in 65.3% (FCM) and 52.7% (placebo) of patients (OR 1.68, 95%CI 1.05-2.70; p = 0.03). A 50% reduction of PFS score was achieved in 33.3% FCM- vs. 16.4% placebo-treated patients (p<0.001). At Day 56, all FCM-treated patients had hemoglobin levels ≥120 g/L (vs. 87% at baseline); with placebo, the proportion decreased from 86% to 81%. Mental quality-of-life (SF-12) and the cognitive function scores improved better with FCM. 'Power of attention' improved better in FCM-treated patients with ferritin <15 µg/L. Treatment-emergent adverse events (placebo 114, FCM 209; most frequently headache, nasopharyngitis, pyrexia and nausea) were mainly mild or moderate.ConclusionA single infusion of FCM improved fatigue, mental quality-of-life, cognitive function and erythropoiesis in iron-deficient women with normal or borderline hemoglobin. Although more side effects were reported compared to placebo, FCM can be an effective alternative in patients who cannot tolerate or use oral iron, the common treatment of iron deficiency. Overall, the results support the hypothesis that iron deficiency can affect women's health, and a normal iron status should be maintained independent of hemoglobin levels.Trial registrationClinicalTrials.gov NCT01110356.

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.

Dataset Information

A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ferric Carboxymaltose in Iron-Deficient Patients with Fibromyalgia.

Publications

A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ferric Carboxymaltose in Iron-Deficient Patients with Fibromyalgia.

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