Ferric carboxymaltose vs. oral iron in the treatment of pregnant women with iron deficiency anemia: an international, open-label, randomized controlled trial (FER-ASAP)
| العنوان: | Ferric carboxymaltose vs. oral iron in the treatment of pregnant women with iron deficiency anemia: an international, open-label, randomized controlled trial (FER-ASAP) |
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| المؤلفون: | Anna Mezzacasa, Joachim W. Dudenhausen, Roubert Bernard, Christian Breymann, Nils Milman, Fer-Asap investigators |
| المساهمون: | University of Zurich, Breymann, Christian |
| المصدر: | Journal of Perinatal Medicine. 45:443-453 |
| بيانات النشر: | Walter de Gruyter GmbH, 2016. |
| سنة النشر: | 2016 |
| مصطلحات موضوعية: | Adult, medicine.medical_specialty, Anemia, Administration, Oral, 610 Medicine & health, Ferric Compounds, Gastroenterology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Pregnancy, law, Internal medicine, medicine, Humans, 2735 Pediatrics, Perinatology and Child Health, Ferrous Compounds, 030212 general & internal medicine, Maltose, Adverse effect, 10026 Clinic for Obstetrics, 030219 obstetrics & reproductive medicine, Anemia, Iron-Deficiency, business.industry, Pregnancy Complications, Hematologic, Infant, Newborn, Obstetrics and Gynecology, 2729 Obstetrics and Gynecology, Odds ratio, medicine.disease, Confidence interval, Treatment Outcome, Iron-deficiency anemia, Pediatrics, Perinatology and Child Health, Quality of Life, Administration, Intravenous, Female, Hemoglobin, business |
| الوصف: | Objective: To compare the efficacy and safety of intravenous ferric carboxymaltose (FCM) with first-line oral ferrous sulfate (FS) in pregnant women with iron deficiency anemia (IDA). Materials and methods: Pregnant women (n=252; gestational weeks 16–33) with IDA were randomized 1:1 to FCM (1000–1500 mg iron) or FS (200 mg iron/day) for 12 weeks. The primary objective was to compare efficacy; secondary objectives included safety and quality of life. Results: Hemoglobin (Hb) levels improved at comparable rates across both treatments; however, significantly more women achieved anemia correction with FCM vs. FS [Hb ≥11.0 g/dL; 84% vs. 70%; odds ratio (OR): 2.06, 95% confidence interval (CI): 1.07, 3.97; P=0.031] and within a shorter time frame (median 3.4 vs. 4.3 weeks). FCM treatment significantly improved vitality (P=0.025) and social functioning (P=0.049) prior to delivery. Treatment-related adverse events were experienced by 14 (FCM; 11%) and 19 (FS; 15%) women, with markedly higher rates of gastrointestinal disorders reported with FS (16 women) than with FCM (3 women). Newborn characteristics were similar across treatments. Conclusions: During late-stage pregnancy, FCM may be a more appropriate option than first-line oral iron for rapid and effective anemia correction, with additional benefits for vitality and social functioning. |
| وصف الملف: | 2016_29_Ferric carboxymaltose vs. oral iron_Breymann.pdf - application/pdf |
| تدمد: | 1619-3997 0300-5577 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5bf68834109ca4102fd65255c18c454b https://doi.org/10.1515/jpm-2016-0050 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....5bf68834109ca4102fd65255c18c454b |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 16193997 03005577 |
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