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https://www.readbyqxmd.com/read/29756335/treatment-of-restless-legs-syndrome-evidence-based-review-and-implications-for-clinical-practice-revised-2017-%C3%A2
#1
REVIEW
Juliane Winkelmann, Richard P Allen, Birgit Högl, Yuichi Inoue, Wolfgang Oertel, Aaro V Salminen, John W Winkelman, Claudia Trenkwalder, Cristina Sampaio
The objective of the current review was to update the previous evidence-based medicine review of treatments for restless legs syndrome published in 2008. All randomized, controlled trials (level I) with a high quality score published between January 2007 and January 2017 were reviewed. Forty new studies qualified for efficacy review. Pregabalin, gabapentin enacarbil, and oxycodone/naloxone, which did not appear in the previous review, have accrued data to be considered efficacious. Likewise, new data enable the modification of the level of efficacy for rotigotine from likely efficacious to efficacious...
May 14, 2018: Movement Disorders: Official Journal of the Movement Disorder Society
https://www.readbyqxmd.com/read/29740690/treatment-of-iron-deficiency-and-iron-deficiency-anemia-with-intravenous-ferric-carboxymaltose-in-pregnancy
#2
Bernd Froessler, Tijana Gajic, Gustaaf Dekker, Nicolette A Hodyl
PURPOSE: To evaluate the efficacy and safety of intravenous ferric carboxymaltose administration to pregnant women with varying severities of iron deficiency anemia and iron deficiency without anemia. METHODS: In this prospective observational study of local obstetric practice, we analyzed data from 863 pregnant women with iron deficiency according to anemia status and severity. All women were treated with intravenous ferric carboxymaltose in pregnancy. Treatment efficacy was assessed by repeat hemoglobin measurements at 3 and 6 week post-infusion and ferritin levels, where available...
May 8, 2018: Archives of Gynecology and Obstetrics
https://www.readbyqxmd.com/read/29731670/assessing-the-costs-and-benefits-of-perioperative-iron-deficiency-anemia-management-with-ferric-carboxymaltose-in-germany
#3
Bernd Froessler, Alexandra M Rueger, Mark P Connolly
Background: Perioperative administration of ferric carboxymaltose (FCM) was previously shown to reduce both the need for transfusions and the hospital length of stay in patients with preoperative iron deficiency anemia (IDA). In this study, we estimated the economic consequences of perioperative administration using FCM vs usual care in patients with IDA from the perspective of a German hospital using decision-analytic modeling. Materials and methods: The model was populated with clinical inputs (transfusion rates, blood units transfused, hospital length of stay) from a previously reported randomized trial comparing FCM vs usual care for managing IDA patients undergoing elective abdominal surgery...
2018: Risk Management and Healthcare Policy
https://www.readbyqxmd.com/read/29707741/myocardial-energetics-and-heart-failure-a-review-of-recent-therapeutic-trials
#4
REVIEW
Kunal N Bhatt, Javed Butler
PURPOSE OF REVIEW: Several novel therapeutics being tested in patients with heart failure are based on myocardial energetics. This review will provide a summary of the recent trials in this area, including therapeutic options targeting various aspects of cellular and mitochondrial metabolism. RECENT FINDINGS: Agents that improve the energetic balance in myocardial cells have the potential to improve clinical heart failure status. The most promising therapies currently under investigation in this arena include (1) elamipretide, a cardiolipin stabilizer; (2) repletion of iron deficiency with intravenous ferrous carboxymaltose; (3) coenzyme Q10; and (4) the partial adenosine receptor antagonists capadenoson and neladenosone...
April 30, 2018: Current Heart Failure Reports
https://www.readbyqxmd.com/read/29680173/iron-deficiency-in-chronic-and-acute-heart-failure-a-contemporary-review-on-intertwined-conditions
#5
REVIEW
Gonçalo J L Cunha, Bruno M L Rocha, Luiz Menezes Falcão
Iron Deficiency (ID) is increasingly recognized as a prevalent comorbid condition in Heart Failure (HF). Despite this, the pathophysiological mechanisms for progressive ID in either chronic or acute HF are still poorly understood. Beyond the traditional factors for iron deficit in the general population, we ought to review the specificities of such paucity in the HF patient, particularly focusing on the interplay between heightened inflammation, overactivity of the sympathetic nervous system and the so-called cardio-renal-anaemia-ID syndrome...
April 18, 2018: European Journal of Internal Medicine
https://www.readbyqxmd.com/read/29669068/adverse-reactions-after-intravenous-iron-infusion-among-inflammatory-bowel-disease-patients-in-the-united-states-2010-2014
#6
Eboselume Akhuemonkhan, Alyssa Parian, Kathryn A Carson, Susan Hutfless
Background: Anemia is a frequent complication of Crohn's disease (CD) and ulcerative colitis (UC), collectively known as inflammatory bowel disease (IBD). Intravenous (IV) iron is recommended as the initial therapy for patients with clinically active IBD, severe anemia, and intolerance to oral iron. IV iron is associated with serious adverse effects including a black box warning for anaphylaxis with iron dextran and ferumoxytol. We aimed to examine the occurrence of adverse reactions including anaphylaxis after IV iron infusions in a large database of US IBD patients...
April 13, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29607528/changes-in-myocardial-iron-content-following-administration-of-intravenous-iron-myocardial-iron-study-design
#7
Gema Miñana, Ingrid Cardells, Patricia Palau, Pau Llàcer, Lorenzo Fácila, Luis Almenar, Maria Pilar López-Lereu, Jose V Monmeneu, Martina Amiguet, Jessika González, Alicia Serrano, Vicente Montagud, Raquel López-Vilella, Ernesto Valero, Sergio García-Blas, Vicent Bodí, Rafael de la Espriella-Juan, Juan Sanchis, Francisco J Chorro, Antoni Bayés-Genís, Julio Núñez
BRIEF TRIAL SUMMARY BACKGROUND: Treatment with intravenous ferric carboxymaltose (FCM) showed to improve symptoms, functional capacity, and quality of life in patients with heart failure (HF) and iron deficiency (ID). However, the underlying mechanisms for these beneficial effects remain undetermined. The aim of this study is to quantify cardiac magnetic resonance (CMR) changes in myocardial iron content after administration of intravenous FCM in patients with HF and ID and contrast them with parameters of HF severity...
April 1, 2018: Clinical Cardiology
https://www.readbyqxmd.com/read/29593459/post-operative-iron-carboxymaltose-may-have-an-effect-on-haemoglobin-levels-in-cardiothoracic-surgical-patients-on-the-icu-an-observational-pilot-study-about-anaemia-treatment-with-intravenous-iron
#8
Frank Peters, Maria Eveslage, Inka Gallitz, Carola Wempe, Patrick Meybohm, Hugo K Van Aken, Andrea U Steinbicker
Background: Post-operative anaemia is associated with increased morbidity and mortality. Positive effects of post-operative intravenous iron (IVI) after elective orthopaedic, abdominal and genitourinary surgery have been reported. The current observational trial investigated the prevalence of post-operative anaemia, the effect of IVI on haemoglobin levels, the use of blood transfusions and diagnoses related to infections. Methods: 1,265 patients on five ICUs of Münster University Hospital were screened for post-operative anaemia...
January 2018: Transfusion Medicine and Hemotherapy
https://www.readbyqxmd.com/read/29582437/red-blood-cell-transfusion-after-a-global-strategy-for-early-detection-and-treatment-of-iron-deficiency-anemia-three-year-results-of-a-prospective-observational-study
#9
Miguel Angel de Las Nieves Lopez, Ana Maria Matas Cobos, Francisco Sarria Gonzalez, Maria Jose Dominguez Lomeña, Ana Maria Palomo Hernandez, Encarnación Gil Gines, Salvador Serna Juan, Javier Ampuero Ampuero, Antonio Marin Fernandez, Antonia Vazquez de la Villa
BACKGROUND: Anemia is the main indication for red blood cell (RBC) transfusion and iron deficiency is the most prevalent, preventable, and treatable cause of anemia worldwide. We aimed to assess the impact of iron deficiency anemia (IDA) on RBC transfusion by means of a program for prevention, early detection, and treatment. STUDY DESIGN AND METHODS: A prospective observational study was conducted starting in 2014 after an intervention in clinical practice in Melilla, a peripheral city isolated by 207 km sea distance to nearest continental Spain...
March 26, 2018: Transfusion
https://www.readbyqxmd.com/read/29564043/postoperative-intravenous-ferric-carboxymaltose-reduces-transfusion-amounts-after-orthopedic-hip-surgery
#10
Sun Ki Kim, Won Yeong Seo, Hee Joong Kim, Jeong Joon Yoo
Background: This retrospective study was performed to determine whether postoperative intravenous ferric carboxymaltose reduces transfusion amounts without influencing clinical outcomes in patients that have undergone hip surgery. Methods: Between May 2014 and April 2016, the authors adopted a new perioperative blood management protocol involving the administration of intravenous ferric carboxymaltose after hip surgeries. One-to-one matching between the 150 patients treated during this period with 150 patients treated before initiation of the new protocol was performed by propensity scoring for age, sex, diagnosis, and type of hip surgery...
March 2018: Clinics in Orthopedic Surgery
https://www.readbyqxmd.com/read/29538179/intravenous-iron-does-not-augment-the-haemoglobin-mass-response-to-simulated-hypoxia
#11
Laura A Garvican-Lewis, Victor L Vuong, Andrew D Govus, Peter Peeling, Grace Jung, Elizabeta Nemeth, David Hughes, Greg Lovell, Daniel Eichner, Christopher J Gore
PURPOSE: Iron is integral for erythropoietic adaptation to hypoxia, yet the importance of supplementary iron compared to existing stores is poorly understood. The aim of the present study was to compare the magnitude of the haemoglobin mass (Hbmass) response to altitude in athletes supplemented with intravenous (IV), oral or placebo iron supplementation. METHODS: Thirty-four, non-anaemic, endurance-trained athletes completed 3 weeks of simulated altitude (3000 m, 14h...
March 12, 2018: Medicine and Science in Sports and Exercise
https://www.readbyqxmd.com/read/29532438/ferric-carboxymaltose-a-review-in-iron-deficiency
#12
Lesley J Scott
Intravenous ferric carboxymaltose (Ferinject® ; Injectafer® ) is a colloidal solution of nanoparticles which consist of a polynuclear iron (III)-(oxyhydr)oxide core stabilized by carboxymaltose and may be given as a single high-dose, 15-min infusion. This article reviews the clinical use of ferric carboxymaltose in various patient populations with iron deficiency (ID) [± anaemia] and briefly summarizes its pharmacological properties. Based on extensive experience in the clinical trial and real-world settings, ferric carboxymaltose is an effective and generally well tolerated treatment for rapidly replenishing iron stores and correcting anaemia in patients with ID (± anaemia) of various aetiologies, including patients with chronic heart failure (CHF), chronic kidney disease, inflammatory bowel disease or perioperative anaemia, and women with ID during pregnancy, postpartum or associated with heavy uterine bleeding...
March 2018: Drugs
https://www.readbyqxmd.com/read/29520555/financial-impact-of-intravenous-iron-treatments-on-the-management-of-anaemia-inpatients-a-1-year-observational-study
#13
Amina Delpeuch, Marc Ruivard, Armand Abergel, Olivier Aumaitre, Stéphane Boisgard, Sandrine Bagel, Valérie Sautou
Background Intravenous (IV) iron preparations bypass the difficulties (malabsorption and side effects) associated with oral iron for the treatment of iron deficiency anaemia (IDA). Ferric carboxymaltose (FCM) can be administered as a single infusion over short periods of time but is more expensive than iron sucrose (IS) when the patients are hospitalized. Objectives To evaluate the appropriateness of FCM prescriptions and to establish the economic impact of this management (including disease coding) compared to the use of IV IS...
March 8, 2018: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/29498039/retrospective-cohort-study-comparing-the-adverse-reactions-and-efficacy-of-intravenous-iron-polymaltose-with-ferric-carboxymaltose-for-iron-deficiency-anemia
#14
Christine E Gilmartin, Thu Hoang, Briony A Cutts, Laura Leung
OBJECTIVE: To examine the adverse drug reactions (ADRs) and the efficacy of intravenous iron polymaltose and ferric carboxymaltose (FCM) among gynecology/obstetric patients with anemia. METHODS: The present retrospective observational study examined data from anemic obstetrics and gynecology patients who received either iron polymaltose or FCM between January 1, 2011, and April 30, 2015, at The Royal Women's Hospital, Victoria, Australia. Patient demographic data, dosage, ADR documentation, and hemoglobin levels were collected from medical records and compared...
June 2018: International Journal of Gynaecology and Obstetrics
https://www.readbyqxmd.com/read/29468908/inflammatory-bowel-disease-and-anemia-intravenous-iron-treatment
#15
Mikael Kangaspunta, Johanna Haapamäki, Martti Färkkilä, Perttu Arkkila
OBJECTIVES: The main objective of our study was to determinate the effectiveness of intravenous iron treatment with ferric carboxymaltose in inflammatory bowel disease (IBD) patients. Our other objectives were to study parameters that would predict a good response to the treatment and to chart out possible side-effects of the treatment. MATERIALS AND METHODS: In our retrospective chart review study we collected clinical data and laboratory results related to IBD from medical records of 87 IBD patients who were treated with ferric carboxymaltose in Helsinki University Hospital between 2014 and 2016...
April 2018: Scandinavian Journal of Gastroenterology
https://www.readbyqxmd.com/read/29458749/efficacy-of-ferric-carboxymaltose-fcm-500-mg-dose-for-the-treatment-of-restless-legs-syndrome
#16
Yong Won Cho, Richard P Allen, Christopher J Earley
INTRODUCTION: There have been four randomized, placebo-controlled, double-blinded studies of intravenous (IV) iron in Restless Legs Syndrome (RLS), all of which delivered a final total dose of 1000 mg of iron. The purpose of this study was to evaluate effects of a lesser total dose (500 mg of iron). METHODS: Subjects with idiopathic RLS were enrolled in a randomized, double-blinded, placebo-controlled study. Subjects received either 500 mg ferric carboxymaltose (FCM) or placebo as a single infusion (Phase I)...
February 2018: Sleep Medicine
https://www.readbyqxmd.com/read/29454888/bioequivalence-decision-for-nanoparticular-iron-complex-drugs-for-parenteral-administration-based-on-their-disposition
#17
Julia Schnorr, Sören Fütterer, Karsten Spicher, Maria Catarinolo, Christoph Schlösser, Harald Enzmann, Peter Langguth
Although parenteral iron products have been established to medicinal use decades before, their structure and pharmacokinetic properties are not fully characterized yet. With its' second reflection paper on intravenous iron-based nano-colloidal products (EMA/CHMP/SWP/620008/2012) the European Medicine Agency provided an extensive catalogue of methods for quality, non-clinical and pharmacokinetic studies for the comparison of nano-sized iron products to an originator (EMA, 2015). For iron distribution studies, the reflection paper assumed the use of rodents...
April 2018: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29425576/evidence-based-and-consensus-clinical-practice-guidelines-for-the-iron-treatment-of-restless-legs-syndrome-willis-ekbom-disease-in-adults-and-children-an-irlssg-task-force-report
#18
Richard P Allen, Daniel L Picchietti, Michael Auerbach, Yong Won Cho, James R Connor, Christopher J Earley, Diego Garcia-Borreguero, Suresh Kotagal, Mauro Manconi, William Ondo, Jan Ulfberg, John W Winkelman
BACKGROUND: Brain iron deficiency has been implicated in the pathophysiology of RLS, and current RLS treatment guidelines recommend iron treatment when peripheral iron levels are low. In order to assess the evidence on the oral and intravenous (IV) iron treatment of RLS and periodic limb movement disorder (PLMD) in adults and children, the International Restless Legs Syndrome Study Group (IRLSSG) formed a task force to review these studies and provide evidence-based and consensus guidelines for the iron treatment of RLS in adults, and RLS and PLMD in children...
January 2018: Sleep Medicine
https://www.readbyqxmd.com/read/29417614/comparative-safety-of-intravenous-ferumoxytol-versus-ferric-carboxymaltose-in-iron-deficiency-anemia-a-randomized-trial
#19
N Franklin Adkinson, William E Strauss, Iain C Macdougall, Kristine E Bernard, Michael Auerbach, Robert F Kaper, Glenn M Chertow, Julie S Krop
Few trials have examined rates of hypersensitivity reactions (HSRs) with intravenous iron formulations used to treat iron deficiency anemia (IDA). This randomized, multicenter, double-blind clinical trial compared the safety, and efficacy of ferumoxytol versus ferric carboxymaltose (FCM), focusing on rates of HSRs and hypotension as the primary end point. Patients with IDA of any etiology in whom oral iron was unsatisfactory or intolerable received ferumoxytol (n = 997) or FCM (n = 1000) intravenously over ≥15 minutes on days 1 and 8 or 9 for total respective doses of 1...
May 2018: American Journal of Hematology
https://www.readbyqxmd.com/read/29357079/pharmacokinetics-pharmacodynamics-safety-and-tolerability-of-intravenous-ferric-carboxymaltose-a-dose-escalation-study-in-japanese-volunteers-with-iron-deficiency-anemia
#20
Katsuya Ikuta, Asami Shimura, Masaru Terauchi, Kazuyoshi Yoshii, Yoshihiro Kawabata
Iron-deficiency anemia (IDA) is the most common form of anemia. Iron replacement therapy is an effective treatment, but oral and previously available intravenous (IV) formulations in Japan have disadvantages such as side effects, immunogenic reactions, low dose per tablet/vial, and the need for continuous administration. Ferric carboxymaltose (FCM), which overcomes these limitations, is widely used as an IV iron preparation outside of Japan. In this single-center, open-label, single-dose escalation study, we investigated the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of FCM in Japanese subjects...
May 2018: International Journal of Hematology
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