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Alternative IV Lipid Emulsions Alternative IV Lipid Emulsions Michelle Henry, MPH, RD, CNSC Medical Science Liaison, Fresenius Kabi LLC, USA Oley Conference January 2017 • Provide brief background on lipids and their function • Discuss the evolution of IVLEs • Discuss the IVLEs approved in the US and their component oils • Introduce a new alternative lipid emulsion available on the US market © Copyright Fresenius Kabi AG 2 • Biological substances that are soluble in organic solvents but insoluble in water Where are they found? • Soybeans/Vegetables • Walnuts/Peanuts • Fish • Avocado/Olives • Coconuts • Eggs, milk, animal meats © Copyright Fresenius Kabi AG 3 • Dense source of energy • Provides essential fatty acids1,2 • Important in structural components of cell membranes1 • Carry lipid soluble vitamins • Involved in hormone and enzyme production • Important in immune and inflammatory responses1 1. Hise M, Brown JC. The ASPEN Adult Nutrition Support Core Curriculum. 2nd Edition, 2012. Silver Springs, MD: American Society for Parenteral and Enteral Nutrition. 2. Escott-Stump S, Dorner S, Grodner M. Nutritional Foundations and Clinical Applications: A Nursing Approach. 6th Edition, 2012. St Louis, Missouri. © Copyright Fresenius Kabi AG 4 Triglycerides1 • The most abundant lipids in the body Glycerol • Fatty acids: the fundamental building blocks of lipids (Extracellular) Hydrophilic 1 polar head Phospholipids group Hydrophobic Phospholipid non-polar tail bilayer • The components of the lipid bilayer of cell membranes (Intracellular) 1. Hise M, Brown JC. The ASPEN Adult Nutrition Support Core Curriculum. 2nd Edition, 2012. Silver Springs, MD: American Society for Parenteral and Enteral Nutrition. © Copyright Fresenius Kabi AG 5 H3C Stearic acid (18:0) COOH 1 double bond = Monounsaturated Fatty Acids (MUFAs) Double bond Oleic acid (18:1ω-9) H3C COOH 2 or more double bonds = Polyunsaturated Fatty Acids (PUFAs) Double bonds H3C COOH Alpha-Linolenic acid (18:3ω-3) © Copyright Fresenius Kabi AG 6 METABOLIC PATHWAYS OF �-3, �-6, �-9 FATTY ACIDS PARENT Essential Fatty Acid PARENT Essential Fatty Acid NON-EFA Omega-9 Fatty Acids Oleic Acid (OA) 18:1 ω9 delta-6-desaturase delta-6-desaturase Octadecatetraenoic Acid Gamma-Linolenic Acid Octadecadienoic Acid 18:4 ω3 18:3 ω6 18:2 ω9 elongase elongase Eicosatetraenoic Acid Dihomo-Gamma-Linolenic Eicosadienoic Acid 20:4 ω3 Acid 20:3 ω6 20:2 ω9 delta-5-desaturase delta-5-desaturase Eicosapentaenoic Acid (EPA) Arachidonic Acid (AA) Eicosatrienoic Acid 20:5 ω3 20:4 ω6 (Mead Acid) elongase 20:3 ω9 Docosapentaenoic Acid Docosatetraenoic Acid 22:5 ω3 22:4 ω6 elongase Tetraene Triene 24:5 ω3 24:4 ω6 delta-6-desaturase 24:6 ω3 24:5 ω6 Beta-oxidation Docosahexaenoic Acid (DHA) Docosapentaenoic Acid 22:6 ω3 22:5 ω6 Adapted from Le HD, et al. Prostaglandins Leukot Essent Fatty Acids. 2009;81:165-170. With permission from Elsevier. © Copyright Fresenius Kabi AG 7 FATTY ACID 9 kcal/g Fluidity Enzymes Receptors Eicosanoids Ion Channels • Prostaglandins Cytokines • Leukotrienes • Thromboxanes Immune Cell and • Protectins Other Cell Types • Resolvins (Various Functions) • Lipoxins 1. Hise M, Brown JC. The ASPEN Adult Nutrition Support Core Curriculum. 2nd Edition, 2012. Silver Springs, MD: American Society for Parenteral© andCopyright Enteral Fresenius Nutrition. Kabi AG 8 What is an EFA? • An EFA cannot be synthesized by the human body and must therefore be acquired in diet1 • Essential for growth, development, and function2 • Utilized primarily in 3 metabolic pathways3: Which fatty acids are essential? • Alpha-Linolenic Acid 18:3ω-3 • Linoleic Acid 18:2ω-6 1. Wanten G, Calder P. Am J Clin Nutr. 2007;85:1171-1184. 2. Le HD, et al. Prostaglandins Leukot Essent Fatty Acids. 2009;81:165-170. 3. Hise M, Brown JC. The ASPEN Adult Nutrition Support Core Curriculum. 2nd Edition, 2012. Silver Springs, MD: American Society for Parenteral and Enteral Nutrition. © Copyright Fresenius Kabi AG 9 Evolution of IVLEs 10 Structured triglyceride 1960 1961 1984 1996 1998 2000 2005 Cottonseed Oil 100% soy MCT/LCT 80% olive, Fish oil parenteral Structured Fish oil-containing First IVLE emulsion became emulsions 20% soy2 supplement 2 mixture formulations 2 available, quickly the first made of of MCT removed for industrially soy and and LCT3 significant side available coconut oil effects2 IVLE for PN2 AND IVLE 50:50 soy oil and safflower oil2 IVLE=intravenous lipid emulsions; PN=parenteral nutrition; MCT=medium-chain triglyceride; LCT=long-chain triglyceride 1. Helfrick FW, et al. J Pediatr 1944;25:400–3. 2. Vanek WV, et al. Nutr in Clin Pract 2012;27:150–92. 3. Osborn HT, et al. Compr Rev Food Sci Food Safety 2002;3:110–20. © Copyright Fresenius Kabi AG 11 US Approvals Soybean Oil / Smoflipid® Medium-Chain TG Soybean Oil + No longer Structured & Medium-Chain TG available. Physical Mixture + Olive Oil + Fish Oil Soybean Oil + Intralipid Intralipid Safflower Oil Fish Oil (Soybean Oil) (Soybean Oil) (Liposyn) (Omegaven) 1960s 1970s 1980s 1990s 2000s 2010s Soybean Oil + Soybean Oil Medium-Chain Soybean oil + Olive Oil TG + MCT + Pre-1960 + Fish Oil Olive + Fish oil Lipomul Soybean Oil + (Cottonseed Oil) Medium-Chain TG Removed from market due to significant Olive oil + side effects in 1960s soybean oil Approved, but not MCT=medium-chain triglyceride; TG=triglyceride available for © Copyright Freseniuspurchase. Kabi AG 12 IVLEs Available in the US 1 3 Intralipid1,2 Nutrilipid3 Clinolipid2,4 Smoflipid5 Fresenius Kabi/ Manufacturer B. Braun Medical Baxter Fresenius Kabi Baxter* Soybean Oil 30% Olive Oil 80% MCT 30% Oil Source Soybean Oil Soybean Oil Soybean Oil 20% Olive Oil 25% Fish Oil 15% Fat Composition (%, mean values)1-5 Linoleic 53 53 17.9 19.5 α-Linolenic 7.5 7.5 2.4 2.5 Eicosapentaenoic (EPA) 0 0 0 2.3 Docosahexaenoic (DHA) 0 0 0 2.3 α-Tocopherol (mg/L) 38 n/a 32 163-225 IVLE=intravenous lipid emulsion; MCT=medium chain triglyceride *Distributed 1. Intralipid Prescribing Information, 2015. 2. Vanek VW, et al. Nutr Clin Pract. 2012;27:150-192. 3. Nutrilipid Prescribing Information 2014, B. Braun Medical, Inc. 4. Clinolipid Prescribing Information, 2013. 5. Smoflipid Prescribing Information 2016. © Copyright Fresenius Kabi AG Intralipid1 Nutrilipid1 Clinolipid1 Smofipid2 Omegaven2* MCT=medium chain triglyceride * Not approved in the US 1. Adapted from: Chang MI, et al. Nutrients 2012;4:1828-1850. (Meisel JA, et al. J Ped Surg. 2011;46:666-673). 2. Fresenius Kabi, Data on File. © Copyright Fresenius Kabi AG 15 • Only available IVLE source in the U.S. from 1970 to 2016 • Soybean oil contains an average of: • 50% Linoleic Acid (LA) • 7% α-linolenic acid (ALA)1 – Prevents EFAD • High ω-6 fatty acid content: precursors to pro-inflammatory eicosanoids2,3 1. Calder PC. Proc Nutr Soc. 2013;72:263-276. 2. Waitzberg DL, et al. JPEN J Parenter Enteral Nutr, 2006;30(4):351 3. Calder PC. Intensive Care Med; 2010;36(5)375. © Copyright Fresenius Kabi AG 16 • IVLE with MCT available outside the U.S. since the mid-1980s • MCT is found in coconut oil and palm kernel oil1 • Good source of energy1 (8 kcal/g) – Provides rapidly available energy2,3 • Efficient triglyceride clearance from bloodstream2 • Have been added to some IVLEs to decrease ω-6 fatty acid1 – Are always mixed with soybean oil for IVLE1 1. Wanten GJ, Calder PC. Am J Clin Nutr. 2007;85:1171-1184. 2. Bach AC, Bayaban VK. Am J Clin Nutr. 1982:36:950-962. 3. Calder PC. Proc Nutr Soc. 2013;72:263-276. © Copyright Fresenius Kabi AG 17 • IVLE with OO available outside the U.S. since 1990s1 • Provides MUFA, primarily oleic acid1 • Less prone to peroxidation than PUFA2,3 • Not converted into active mediators of inflammatory processes4 • Provides small amounts of linoleic and α-linolenic acid for EFA 1. Calder PC. Proc Nutr Soc. 2013;72:263-276. 2. Wanten GJ. JPEN J Parenter Enteral Nutr. 2015;39 suppl 1:33S-38S. 3. Hise M, Brown JC. Lipids. The ASPEN Adult Nutrition Support Core Curriculum. 2nd Edition, 2012. 4. Waitzberg DL, et al. JPEN J Parenter Enteral Nutr 2006;30:351-367. © Copyright Fresenius Kabi AG 18 • IVLE with FO available outside the U.S. since mid-1990s • Very rich in omega-3 fatty acids • Provides “conditionally essential” fatty acids1-3 – EPA and DHA • Provides precursors to less inflammatory eicosanoids and specialized pro-resolving mediators4 1. Le HD, et al. Prostaglandins Leukot Essent Fatty Acids 2009; 81:165-170. 2. Kalish BT, et al. JPEN J Parenter Enteral Nutr 2012;36:380-388. 3. Bistrian B. JPEN J Parenter Enteral Nutr 2003;27(3)168-175. 4. Kremmyda LS, et al. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2011;155:195-218. © Copyright Fresenius Kabi AG 19 Medium- Safflower Soybean Chain Olive Fish Oil Oil Triglyceride Oil Oil Oil Note: This is a relative (not absolute) figurative scale to demonstrate relative inflammatory activity Vanek VW, et al. Nutr Clin Pract. 2012;27:150-192. © Copyright Fresenius Kabi AG 20 21 Smoflipid is a new lipid IVLE option for adults in the United States • IV lipid emulsion product made with four different types of oils: Soy, MCT, Olive and Fish • Provides energy and EFAs • Safe, well tolerated, and has demonstrated efficacy © Copyright Fresenius Kabi AG 22 Soy Oil • Source of essential fatty acids 30% (ω-6) • Provides energy • Source of rapidly available energy1 30% MCTs • Clears faster from the bloodstream than other fatty acids2 Olive Oil • Contains small amount of linoleic acid 25% and α-linolenic acid (ω-9) • Immune neutral3 • Source of conditionally essential fatty acids Fish Oil 4 15% EPA & DHA (ω-3) • Precursors to less inflammatory eicosanoids5 α-tocopherol (approx. 200 mg/L) is an important antioxidant that protects long-chain polyunsaturated fats from peroxidation6.7 1. Deckelbaum RJ, et al. Biochemistry (Mosc) 1990;29(5):1136-1142; 5.
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