Clinical Review Report for Sodium Zirconium Cyclosilicate (Lokelma) 2

Total Page:16

File Type:pdf, Size:1020Kb

Clinical Review Report for Sodium Zirconium Cyclosilicate (Lokelma) 2 CADTH COMMON DRUG REVIEW Clinical Review Report SODIUM ZIRCONIUM CYCLOSILICATE (LOKELMA) (AstraZeneca Canada Inc.) Indication: For the treatment of hyperkalemia in adults. Service Line: CADTH Common Drug Review Version: Final Publication Date: May 2020 Report Length: 125 Pages Disclaimer:Disclaimer: The The informationinformation in in this this document document isis intended intended toto help help CanadianCanadian healthhealth carecare decisiondecision--makers,makers, health health care care professionals, professionals, health health systems systems leaders, leaders, andand policy policy--makersmakers make make well well--informedinformed decisions decisions and and therebythereby improve improve the the quality quality of of healthhealth care care services. services. While While pat patientsients and and othersothers maymay access access this this d documenocument,t, thethe document document is is made made available available forfor informational informational purposes purposes only only and and no no representations representations or or warranties warranties are are made made with with respect respect to to itsits fitness fitness for for any any particular particular purpose.purpose. The The informationinformation in in this this document document should should not not be be u usedsed asas a a substitutesubstitute for for profession professionalal medicalmedical adviceadvice or or asas a a substitutesubstitute for for the the application application of of clinical clinical judgmentjudgment in in respect respect of of the the care care of of a a particular particular patient patient or or other other professional professional judgment judgment in in any any decision decision--makingmaking process. process. The The Canadian Canadian AgencyAgency for for Drugs Drugs andand TechnologiesTechnologies inin Health Health (CADTH) (CADTH) doe doess not not endorseendorse anyany information,information, drugs, drugs, therapies,therapies, treatments,treatments, products, products, processes, processes, or or services. servic es. WhileWhile care care has has been been takentaken to to ensure ensure that that the the information information prepared prepared byby CADTH CADTH in in this this document document is is accurate, accurate, complete, complete, and and upup--toto--dadatete asas at at the the applicable applicable datedate thethe m materialaterial was was firstfirst published published byby CADTH, CADTH, CADTHCADTH does does notnot makemake any any guaranteesguarantees toto thatthat effect. effect. CADTH CADTH does does not not guarantee guarantee andand is is not not responsibleresponsible for for the the quality,quality, currency, currency, propriety, propriety, accuracy,accuracy, or or reasonableness reasonableness ofof any any statements, statements, information, information, or or conclusions conclusions contai containedned inin anyany thirdthird--partyparty materials materials used used in in preparing preparing thisthis document. document. The The viewsviews and and opinions opinions ofof third third parties parties published published inin this this document document do do not not necessarily necessarily state state or or reflect reflect those those o off CADTH.CADTH. CADTHCADTH is is not not responsible responsible for for any any erro errors,rs, omissions,omissions, injury, injury, loss, loss, or or dadamagemage arisingarising fromfrom or or relatingrelating toto thethe use use (or(or misuse)misuse) of o fany any information, information, statements, statements, or or conclusionsconclusions contained contained in in or or impliedimplied by by the the contents contents of of this this document document or or any any of of the the source source materials. materials. ThisThis document document may may contain contain links links t too third third--partyparty websites. websites. CADTH CADTH does does notnot havehave controlcontrol over over thethe contentcontent of of such such sites. sites. Use Use of of third third--partyparty sites sites is is governed governed byby thethe third third--partyparty website website owners’ owners’ ownown terms terms and and conditions conditions set set out out for for such such sites. sites. CADTH CADTH does does not not make make any any guarantee guarantee with with respect respect to to a anyny informationinformation containedcontained on on such such t thirdhird--partyparty sites sites and and CADTH CADTH is is not not responsible responsible for for anyany injury, injury, loss, loss, or or damage damage sufferedsuffered as as a a result result of of using using such such third third--partyparty sites. sites .CADTH CADTH hashas no no responsibility responsibility for for thethe collection, collection, use, use, andand disclosure disclosure of of personal personal informatio informationn byby third third--partyparty sites. sites. SubjectSubject to to the the aforementionedaforementioned limitations,limitations, the the views views expressed expressed hereinherein areare thosethose of of CADTHCADTH and and do do not not necessarily necessarily represent represent the the views views of of C Canadanada’sa’s federal,federal, provincial,provincial, or or territorial territorial governments governments oror any any third third party party supplier supplier of of informati informationon.. ThisThis document document is is prepared prepared andand intendedintended forfor use use inin thethe context context of of the the CanadianCanadian healthhealth carecare system. system. The The useuse of of this this document document outside outside of of Canada Canada is is done done soso at at thethe user’s user’s own own risk. risk. ThisThis disclaimer disclaimer and and any any questions questions or or matters matters of of any any nature nature arising arising from from or or r relatingelating toto thethe content content oror useuse (or (or misuse)misuse) of of thisthis document document will will be be governed governed byby and and interpretedinterpreted in in accordanceaccordance with with the the laws laws of of the the Province Province of of Ontario Ontario and and thethe laws laws of o fCanada Canada applicable applicable therein,therein, and and all all proceed proceedingsings shallshall bebe subjectsubject to to thethe exclusiveexclusive jurisdict jurisdictionion ofof the the courtscourts of of the the ProvinceProvince ofof Ontario, Ontario, Canada.Canada. TheThe copyrightcopyright and and other other intellectual intellectual property property rights rights in in this this document document are are owned owned by by CADTH CADTH and and its its licensors. licensors. These These rightsrights are are protectedprotected byby the the CanadianCanadian CopyrightCopyright Act Act and and other other national national and and international international lawslaws and and agreements.agreements. UsersUsers are are perpermittedmitted to to makemake copies copies ofof this this document document forfor non non--commercialcommercial purposes purposes only,only, provided provided itit is is not not modified modified when when reproduced reproduced andand appropriate appropriate creditcredit is is given given to to CADTH CADTH and and itsits licensors. licensors. AboutAbout CADTH:CADTH: CADTH CADTH is is an an independent, independent, notnot--forfor--profitprofit organization organization responsibleresponsible f foror providing providing Canada’sCanada’s healthhealth carecare decisiondecision--makersmakers with with objective objective evidence evidence toto help help makemake informed informed decisions decisions about about the the optimal optimal use use of of drugs, drugs, medical medical devices, devices, diagnostics, diagnostics, and and procedures procedures in in our our health health ca carere system.system. Funding:Funding: CAD CADTHTH receives receives funding funding fromfrom Canada’s Canada’s federal,federal, provincial,provincial, andand territorialterritorial governments,governments, with with the the exceptionexception of of Quebec.Quebec. CADTH COMMON DRUG REVIEW Clinical Review Report for Sodium Zirconium Cyclosilicate (Lokelma) 2 Table of Contents Abbreviations................................................................................................................... 7 Introduction ................................................................................................................................................... 8 Stakeholder Engagement ........................................................................................................................... 9 Clinical Evidence ........................................................................................................................................ 10 Conclusions................................................................................................................................................. 14 Disease Background ................................................................................................................................. 16 Standards of Therapy ................................................................................................................................ 16 Drug.............................................................................................................................................................. 17 Patient Group Input.................................................................................................................................... 19 Clinician Input ............................................................................................................................................
Recommended publications
  • How to Take Your Phosphate Binders
    How to take your phosphate binders Information for renal patients Oxford Kidney Unit Page 2 What are phosphate binders? To reduce the amount of phosphate you absorb from your food you may have been prescribed a medicine called a phosphate binder. Phosphate binders work by binding (attaching) to some of the phosphate in food. This will reduce the amount of phosphate being absorbed into your blood stream. A list of phosphate binders and how to take them is shown below. Phosphate binder How to take it Calcichew (calcium carbonate) Chew thoroughly 10-15 minutes before or immediately before food Renacet (calcium acetate) Phosex (calcium acetate) Osvaren (calcium acetate and magnesium carbonate) Swallow whole after the first Renagel 2-3 mouthfuls of food (sevelemer hydrochloride) Renvela tablets (sevelemer carbonate) Alucaps (aluminium hydroxide) Renvela powder Dissolve in 60ml of water and (sevelemer carbonate) take after the first 2-3 mouthfuls of food Fosrenol tablets Chew thoroughly towards the (lanthanum carbonate) end/immediately after each meal Fosrenol powder Mix with a small amount of (lanthanum carbonate) food and eat immediately Velphoro Chew thoroughly after the first (sucroferric oxyhydroxide) 2-3 mouthfuls The phosphate binder you have been prescribed is: ……………………………………………………………………………………………………………………………………………………….. Page 3 How many phosphate binders should I take? You should follow the dose that has been prescribed for you. Your renal dietitian can advise how best to match your phosphate binders to your meal pattern, as well as which snacks require a phosphate binder. What happens if I forget to take my phosphate binder? For best results, phosphate binders should be taken as instructed.
    [Show full text]
  • Calcium Acetate Capsules
    Calcium Acetate Capsules Type of Posting Revision Bulletin Posting Date 27–Dec–2019 Official Date 01–Jan–2020 Expert Committee Chemical Medicines Monographs 6 Reason for Revision Compliance In accordance with the Rules and Procedures of the 2015–2020 Council of Experts, the Chemical Medicines Monographs 6 Expert Committee has revised the Calcium Acetate Capsules monograph. The purpose for the revision is to add Dissolution Test 4 to accommodate FDA-approved drug products with different dissolution conditions and/or tolerances than the existing dissolution tests. • Dissolution Test 4 was validated using a YMC-Pack ODS-A C18 brand of L1 column. The typical retention time for calcium acetate is about 4.3 min. The Calcium Acetate Capsules Revision Bulletin supersedes the currently official monograph. Should you have any questions, please contact Michael Chang, Senior Scientific Liaison (301-230-3217 or [email protected]). C236679-M11403-CHM62015, rev. 00 20191227 Revision Bulletin Calcium 1 Official January 1, 2020 Calcium Acetate Capsules PERFORMANCE TESTS DEFINITION Change to read: Calcium Acetate Capsules contain NLT 90.0% and NMT · DISSOLUTION á711ñ 110.0% of the labeled amount of calcium acetate Test 1 (C4H6CaO4). Medium: Water; 900 mL IDENTIFICATION Apparatus 2: 50 rpm, with sinkers · A. The retention time of the calcium peak of the Sample Time: 10 min solution corresponds to that of the Standard solution, as Mobile phase, Standard solution, Chromatographic obtained in the Assay. system, and System suitability: Proceed as directed in · B. IDENTIFICATION TESTSÐGENERAL á191ñ, Chemical the Assay. Identification Tests, Acetate Sample solution: Pass a portion of the solution under test Sample solution: 67 mg/mL of calcium acetate from through a suitable filter of 0.45-µm pore size.
    [Show full text]
  • Effect of Lanthanum Carbonate and Calcium Acetate in the Treatment of Hyperphosphatemia in Patients of Chronic Kidney Disease P
    Research Article Effect of lanthanum carbonate and calcium acetate in the treatment of hyperphosphatemia in patients of chronic kidney disease P. Thomas Scaria, Reneega Gangadhar1, Ramdas Pisharody2 ABSTRACT OObjectives:bjectives: The tolerability and efficacy of lanthanum carbonate has not been studied in the Indian population. This study was, therefore, undertaken to compare the efficacy and tolerability of lanthanum carbonate with calcium acetate in patients with stage 4 chronic kidney disease. Departments of Pharmacology and DDesign:esign: A randomized open label two group cross-over study. Therapeutics, Government Medical MMaterialsaterials aandnd MMethods:ethods: Following Institutional Ethics Committee approval and valid College, Thiruvananthapuram, consent, patients with stage 4 chronic kidney disease were randomized to receive either 1 Pharmacology, Government lanthanum carbonate 500 mg thrice daily or calcium acetate 667 mg thrice daily for Medical College, Kottayam, 4 weeks. After a 4-week washout period, the patients were crossed over for another 2Nephrology, Government Medical College, Thiruvananthapuram, 4 weeks. Serum phosphorous, serum calcium, serum alkaline phosphatase, and serum Kerala, India creatinine were estimated at fixed intervals. RResults:esults: Twenty-six patients were enrolled in the study. The mean serum phosphorous RReceived:eceived: 28.03.2008 concentrations showed a declining trend with lanthanum carbonate (from pre-drug levels of RRevised:evised: 12.07.2008 7.88 ± 1.52 mg/dL-7.14 ± 1.51 mg/dL) and calcium acetate (from pre-drug levels of 7.54 ± AAccepted:ccepted: 11.07.2009 1.39 mg/dL-6.51 ± 1.38 mg/dL). A statistically significant difference was seen when comparing the change in serum calcium produced by these drugs (P < 0.05).
    [Show full text]
  • Fosrenol-Pm-En.Pdf
    PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION FOSRENOL® lanthanum carbonate hydrate Chewable tablets, 250 mg, 500 mg, 750 mg, and 1000 mg, oral Phosphate binder ATC code: V03A E03 Takeda Canada Inc. Date of Initial Approval: 22 Adelaide Street West, December 14, 2012 Suite 3800 Toronto Ontario M5H 4E3 Date of Revision: January 5, 2021 Submission Control No: 242595 FOSRENOL® and the FOSRENOL Logo are registered trademarks of Shire International Licensing BV, a Takeda company. Takeda® and the Takeda Logo are trademarks of Takeda Pharmaceutical Company Limited, used under license. FOSRENOL® Product Monograph Page 1 of 31 RECENT MAJOR LABEL CHANGES Not applicable TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................ 2 TABLE OF CONTENTS .................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 4 1 INDICATIONS ...................................................................................................... 4 1.1 Pediatrics ..................................................................................................... 4 1.2 Geriatrics ..................................................................................................... 4 2 CONTRAINDICATIONS ....................................................................................... 4 DOSAGE AND ADMINISTRATION ....................................................................
    [Show full text]
  • Renal Diet for Patients with Diabetes
    Webinar: BDA - Diabetes Specialist Group Renal diet for Patients with Diabetes By Gabby Ramlan Diabetes & Renal Specialist Dietitian Overview • Diabetes Dietitian Vs Renal Dietitian • Problems in individual with kidney disease • Salt • Protein • Phosphate • Potassium • Acute Kidney Injury (AKI) Around 40% people with diabetes eventually develop diabetic nephropathy or diabetes kidney disease. Diabetes is a leading cause of kidney failure in UK – around 20% starting dialysis have diabetes. Kidney Research UK “Dietary requirements for patients with both diabetes and chronic kidney disease (CKD) is more complicated than with each individual condition as it involves multiple nutrients” National Kidney Foundation (NKF) 2007 Diabetes vs Renal Specialist Dietitian Diabetes Renal • Salt • Salt • Lipid control • Lipid control • Carbohydrates • Protein • Glycaemic control • Potassium • OHAs • Fluid • Injectable meds • CKD-MBD • Insulin • Phosphate Binders • Vit D / calcimimetic Kidney’s Functions • Regulation of the composition and volume of body fluids – Na+, K+, Phosphate, Mg – Acid/base balance – BP & volume via renin angiotensin system • Excretion of waste products – Urea (protein metabolism) – Creatinine (muscle metabolism) – Drugs & toxins Kidney’s Fx • Endocrine fx - Erythropoetin & Hb • Metabolic - Control calcium/phosphate/ PTH balance - Vit D metabolism - Excretion of phosphate Common problems with renal patients • Anaemia – no dietary advice CKD – Mineral Bone Disorder (MBD) 1. Vitamin D Fluid Hyperkalaemia 2. Corrected Hypertension 1.
    [Show full text]
  • ACC.Org/Infographics ©2020 American College of Cardiology W20006
    Potassium Binders in the Management of Chronic Hyperkalemia ✖ Development of hyperkalemia can be either acute or chronic depending on the time of onset, the presence or absence of symptoms, and underlying etiology. ✖ Chronic hyperkalemia is a potentially life-threatening condition commonly seen in older patients with heart failure (HF), chronic kidney disease (CKD), and renin-angiotensin- aldosterone system (RAAS) inhibitor therapy. PROBLEM ✖ Although sodium polystyrene sulfonate (Kayexalate®) is widely used for hyperkalemia management, its use has many limitations including: - A lack of robust randomized clinical trials showing evidence for efficacy and safety2 - An association with serious gastrointestinal (GI) injury (e.g. intestinal necrosis)2,5 - Limited use in patients with sodium intake restrictions3 ✔ Prior to initiating potassium binders, patients should be on a low potassium diet and treated with a potassium-wasting diuretic if appropriate. A dose adjustment of RAAS inhibitor therapies should be attempted in patients with CKD. ✔ Newer potassium binders, patiromer and sodium zirconium cyclosilicate, have more robust clinical trials documenting improved safety profile by reducing serum potassium and SOLUTION maintaining normokalemia in patients with HF and CKD.1,6,8,9 - RAAS inhibitors were able to be continued in patients with HF and CKD when receiving concurrent patiromer1,6,9 - Normokalemia was maintained in CKD patients with and without RAAS inhibitors therapy while receiving concurrent sodium zirconium cyclosilicate8 TREATMENT TABLE: Drug Name Patiromer Sodium zirconium cyclosilicate Binds potassium in lumen of GI and increases its fecal excretion Mechanism of Action Colon Small and large intestine Initial dose: 10 grams 3x daily for up to 48hrs 8.4 grams daily Maintenance dose: 10 grams daily Dosing Up-titrate at weekly intervals to reach Up-titrate at weekly intervals by 5 grams desired serum potassium concentration daily to reach desired serum potassium (max.
    [Show full text]
  • New Brunswick Drug Plans Formulary
    New Brunswick Drug Plans Formulary August 2019 Administered by Medavie Blue Cross on Behalf of the Government of New Brunswick TABLE OF CONTENTS Page Introduction.............................................................................................................................................I New Brunswick Drug Plans....................................................................................................................II Exclusions............................................................................................................................................IV Legend..................................................................................................................................................V Anatomical Therapeutic Chemical (ATC) Classification of Drugs A Alimentary Tract and Metabolism 1 B Blood and Blood Forming Organs 23 C Cardiovascular System 31 D Dermatologicals 81 G Genito Urinary System and Sex Hormones 89 H Systemic Hormonal Preparations excluding Sex Hormones 100 J Antiinfectives for Systemic Use 107 L Antineoplastic and Immunomodulating Agents 129 M Musculo-Skeletal System 147 N Nervous System 156 P Antiparasitic Products, Insecticides and Repellants 223 R Respiratory System 225 S Sensory Organs 234 V Various 240 Appendices I-A Abbreviations of Dosage forms.....................................................................A - 1 I-B Abbreviations of Routes................................................................................A - 4 I-C Abbreviations of Units...................................................................................A
    [Show full text]
  • Production and Testing of Calcium Magnesium Acetate in Maine
    77 Majesty's Stationery Office, London, England, River. Res. Note FPL-0229. Forest Service, U.S. 1948. Department of Agriculture, Madison, Wis., 1974. 14. M.S. Aggour and A. Ragab. Safety and Soundness 20. W.L. James. Effect of Temperature and Moisture of Submerged Timber Bridge PU.ing. FHWA/MD In­ Content on Internal Friction and Speed of Sound terim Report AW082-231-046. FHWA, U.S. Depart­ in Douglas Fir. Forest Product Journal, Vol. ment of Transportation, June 1982. 11, No. 9, 1961, pp. 383-390, 15. B.O. Orogbemi. Equipment for Determining the 21. A, Burmester. Relationship Between Sound Veloc­ Dynami c Modulus of Submerged Bridge Timber Pil­ ity and Morphological, Physical, and Mechani­ ·ing. Master's thesis. University of Maryland, cal Properties of Wood. Holz als Roh und Wer­ College Park, 1980. stoff, Vol. 23, No. 6, 1965, pp. 227-236 (in 16. T.L. Wilkinson. Strength Evaluation of Round German) • Timber Piles. Res. Note FPL-101. Forest Ser­ 22. c.c. Gerhards. Stress Wave Speed and MOE of vice, U.S. Department of Agriculture, Madison, Weetgum Ranging from 150 to 15 Percent MC. Wis., 1968. Forest Product Journal, Vol. 25, No. 4, 1975, 17. J, Bodig and B.A. Jayne. Mechanics of Wood and pp. 51-57. Wood Composites. Van Nostrand, New York, 1982. 18. R.M. Armstrong. Structural Properties of Timber Piles, Behavior of Deep Foundations. Report STP-670, ASTM, Philadelphia, 1979, pp. 118-152. 19. B.A, Bendtsen. Bending Strength and Stiffness Publication of this paper sponsored by Committee on of Bridge Piles After 85 Years in the Milwaukee Structures Maintenance.
    [Show full text]
  • Phosphate Binders
    Pharmacy Info Sheet Phosphate Binders calcium acetate, calcium carbonate (Tums, Calsan, Apocal, Ocal), calcium liquid, aluminum hydroxide (Basaljel, Amphojel), sevelamer (Renagel), lanthanum (Fosrenol) What it does: Phosphate binders are used to treat high Special considerations for lanthamum and blood phosphorus levels. sevelamer: Calcium acetate, calcium carbonate, calcium Lanthanum should be taken during or liquid, aluminum hydroxide, lanthanum and immediately after a meal. Taking a dose on an sevelamer bind dietary phosphate. When the empty stomach can cause nausea and kidneys fail, phosphorus builds up in the body vomiting. Chew the tablet completely before because the kidneys can no longer remove swallowing. DO NOT swallow tablets whole. much phosphorus. Phosphate binders are used to lower the amount of phosphorus Sevelamer should be taken just before eating. absorbed from food to limit development of Swallow the tablet whole – Renagel should not bone and blood vessel disease. be cut or chewed. The contents of sevelamer tablets expand in water and could cause Aluminum hydroxide and calcium carbonate choking if cut chewed or crushed. may also be prescribed as antacids. Calcium preparations may also be prescribed as Phosphate binders may interfere with the calcium supplements. Use them only as absorption of certain drugs such as iron prescribed. When these medications are supplements, antibiotics, digoxin, ranitidine, prescribed as calcium supplements or antiseizure, and antiarrhythmic medications. antacids, take between meals. If you are prescribed any of these drugs, take them at least 1 hour before or 3 hours after your How it works: phosphate binder. Kidney disease can cause phosphate to accumulate which results in bone and blood What to do if you miss a dose: vessel disease.
    [Show full text]
  • Bright Pleiotropic Properties in Renal Failure and Dialysis Patients
    Open Access http://www.jparathyroid.com Journal of Journal of Parathyroid Disease 2012,2(2),75–77 Hypothesis Beyond the phosphate binding effect of sevelamer; bright pleiotropic properties in renal failure and dialysis patients Mahmoud Rafieian-Kopaei1, Saeed Mardani2, Hamid Nasri3*, Seyed Seifollah Beladi Mousavi4 hree main mechanisms are responsible for Implication for health policy/practice/research/ hyperphosphatemia, firstly an impaired renal medical education phosphate excretion due to acute or chronic In addition to its labeled property of serum phosphate Trenal insufficiency, secondly a massive acute phosphate reduction in hemodialysis individuals, sevelamer may load, and finally a primary increase in renal phosphate have further effects on factors influencing vascular reabsorption (1-3). Hyperphosphatemia in chronic renal endothelium, like inhibition of progression of vascular failure is related with increased cardiovascular mortality calcification, reduction of fibroblast growth factor 23, and morbidity. Lowering the phosphate load and abolishing of circulating inflammatory and oxidative maintaining serum phosphorus levels within the normal molecules, reducing of total and LDL cholesterol, value are important therapeutic aims to improve clinical uric acid, and uremic toxins. Also sevelamer may outcomes in chronic renal failure patients (1-3). Treatment reduce blood absorption of advanced glycation end comprises of lessening intestinal phosphate absorption products and endotoxins from the intestine. Hence, it is affordable to
    [Show full text]
  • Pharmacology
    Pharmacology The current treatment of hyperkalemia in the emergency department (ED) varies considerably because of limited data on the efficacy of available agents [1]. A recent Cochrane review highlighted the limitations of the available studies [2], however, the United Kingdom Renal Association has developed clinical practice guidelines for the treatment of acute hyperkalemia [3]. Following are the commonly used agents for the treatment of hyperkalemia in the emergent setting. A threefold approach is currently adopted by clinicians: 1. Stabilization of the cardiac membranes 2. Redistribution of potassium 3. Elimination of potassium Stabilization of the Cardiac membranes Calcium The effect of potassium on myocytes is counter- balanced by the concurrent calcium concentration such that intravenous calcium antagonizes hyperkalemia induced cardiac membrane excitability and protects the heart against arrhythmias [4]. It is usually effective within minutes, as noted by an improvement in the ECG appearance or reversal of ECG abnormality. It is generally accepted that intravenous (IV) calcium is indicated for potentially life-threatening ECG changes (absent P waves, wide QRS, sine-wave pattern) [2] [5] [6], arrhythmias, or cardiac arrest [7]. The recommended dose of calcium salts ranges from 1000 – 3000 mg of calcium gluconate (10 - 30 mL of a 10% solution) or 500 -1000 mg of calcium chloride (5- 10 mL of a 10% solution) [5] [8]. The dose can be repeated if there is no effect within 5-10 minutes. Some adverse effects of intravenous calcium are peripheral vasodilation, hypotension, bradycardia, and arrhythmias [9]. A more serious adverse effect of IV calcium is tissue necrosis if extravasation occurs. This can be avoided if calcium gluconate is used, which is considered less toxic on peripheral veins.
    [Show full text]
  • Efficacy and Safety of Sucroferric Oxyhydroxide Compared with Sevelamer
    Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer hydrochloride in Japanese haemodialysis patients with hyperphosphataemia: A randomised, open-label, multicentre, 12-week Phase III study Running title: Safety and efficacy of PA21 vs sevelamer Fumihiko Koiwa1, Keitaro Yokoyama2,, Masafumi Fukagawa3, Akira Terao4, Tadao Akizawa5 1Division of Nephrology, Department of Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan 2Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan 3Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan 4Biostatistics, Faculty of Pharmaceutical Sciences, Josai University, Sakado, Japan 5Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan Corresponding author: Fumihiko Koiwa Division of Nephrology, Department of Medicine, Showa University Fujigaoka Hospital, 1-30 Fujigaoka, Aoba-ku, Yokohama 227-8501, Japan Tel.: +81-45-971-1151 Fax: +81-45-973-3010 Email: [email protected] This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/nep.12891 This article is protected by copyright. All rights reserved. Abstract Aim: We aimed to investigate the non-inferiority of PA21 (sucroferric oxyhydroxide) to sevelamer hydrochloride (sevelamer) in terms of efficacy and safety in Japanese haemodialysis patients with hyperphosphataemia. Methods: In this Phase III, open-label, multicentre study, 213 haemodialysis patients with hyperphosphataemia were randomised to PA21 or sevelamer treatment for 12 weeks. The primary outcome was adjusted serum phosphorus concentration at the end of treatment; the non-inferiority of PA21 was confirmed if the upper limit of the two-sided 95% confidence interval (CI) is ≤0.32 mmol/L.
    [Show full text]