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Understanding SMOFlipid
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Manpreet Mundi, MD

               SMOFlipid® (Fresenius Kabi) has recently been approved by the US Food and Drug Administration (FDA) as a source of calories and essential fatty acids in adult patients who are not able to meet their calorie needs through oral or enteral nutrition (tube feeding). SMOFlipid is a composite parenteral nutrition (PN) lipid, comprised of soybean oil (30%), medium-chain triglycerides (MTCs, 30%), olive oil (25%), and fish oil (15%).

 

               Prior to this approval, lipid emulsions approved by the FDA were either comprised entirely of soybean oil (Intralipid® [Baxter], Liposyn III® [Pfizer], and Nutrilipid® [B. Braun]) or a combination of olive oil and soybean oil in a 4:1 ratio (Clinolipid® [Baxter]). Although many different lipid emulsions have received FDA approval, it is important to note that Intralipid has been the one predominately used by most infusion companies in the United States.

A Source of Calories

               Despite the difference in oils that these lipid emulsions are composed of, they serve as an excellent source of non-protein calories, allowing us to decrease the amount of dextrose provided in the PN. Unfortunately, the amount of soybean oil–based lipid emulsions that can be provided is limited as their long-term use can be associated with complications such as high triglyceride levels, inflammation, and possibly even intestinal failure associated liver disease (IFALD).

 

               Many approaches to limiting these side-effects have been tried. Dr. Darlene Kelly (currently Oley Foundation Advisor for Science and Medicine) and other pioneers in the field noted early on that most home parenteral nutrition (HPN) consumers may not tolerate having lipid emulsions on a daily basis, and that this practice may lead to abnormal liver tests. Based on this observation, they transitioned HPN consumers to infusing lipid emulsions three days per week. For some HPN consumers, even three doses of lipid emulsion per week is too much and is associated with abnormal liver enzymes, which often leads to a further reduction—even as little as one dose every other week.

 

               This makes it very difficult for the consumer to get enough calories. As an example, if a consumer is receiving lipid emulsion three days per week and he or she has abnormal liver test results, the lipid emulsion is typically cut down to one day per week, or lower. The consumer’s medical team can increase the amount of dextrose in his or her PN to compensate, but only to a certain extent. This often leads to the consumer being underfed until the liver tests can come back to normal.

 

A Combination of Oils

               It is suspected that part of the reason the above-mentioned complications occur is that soybean oil tends to have a higher ratio of omega-6 to omega-3 fatty acids. As the omega-6 fatty acids are broken down by our bodies, they tend to generate pro-inflammatory products. Additionally, soybean oil has higher levels of phytosterols, which might also play a role in the development of IFALD. The mixture of different oils (soybean, MTCs, olive, and fish oils) in SMOFlipid tries to counter this. The fish oil and olive oil components tend to raise the amount of omega-3 fatty acids, which tend to be much less pro-inflammatory. Additionally, SMOFlipid is enriched with alpha-tocopherol (vitamin E), which tends to have anti-oxidant properties.

 

               Because of this combination of oils and their possible benefits, the PN community is cautiously optimistic about the use of SMOFlipid. We are optimistic because so far, the studies that have been done have shown that not only is SMOFlipid as safe as soybean oil–based lipid emulsions, but it may have better outcomes in some aspects.

 

               As an example, Klek et al. conducted a study where seventy-three patients who required PN due to intestinal failure were placed on PN containing either soybean oil or SMOFlipid for four weeks. They showed that the levels of some liver tests were lower in those who had been given SMOFlipid compared to those who had had soybean oil–based lipid emulsion. Two subjects in the SMOFlipid group and eight subjects in the soybean oil group developed serious adverse effects but did recover fully.

 

               Despite these positive results, we have to be cautious since the studies done so far have been short-term studies lasting two to four weeks. We need much longer trials before we can confidently say that SMOFlipid is better than the current soybean oil–based lipid emulsions that have been used for decades.


LifelineLetter, January/February 2017

This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.

 

Updated in 2015 with a generous grant from Shire, Inc. 

 

This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.
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