"The U.S. Food and Drug Administration today approved Clinolipid (lipid injectable emulsion, USP) for intravenous feeding (parenteral nutrition) in adult patients, providing a source of calories and essential fatty acids for adult patients who are"...
CLINOLIPID injection administered intravenously provides biologically utilizable source of calories and essential fatty acids.
Mechanism of Action
Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are important for membrane structure and function, precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression.
Metabolism and excretion
The fatty acids, phospholipids, and glycerol found in lipid emulsions are metabolized by cells to carbon dioxide and water. The metabolism of these substances results in the generation of energy in the form of adenosine triphosphate (ATP). Some fatty acids are stored in the body in fat tissue, cell membranes, or as intracellular triglycerides. There is constant turn-over of these tissues, with the result that the lipid components are eventually metabolized to carbon dioxide and water. Carbon dioxide is expired through the lungs. Water is excreted through the kidneys or lost through evaporation/expiration through the skin, lungs, and other tissue surfaces. Some lipids (i.e., phospholipids, cholesterol, and bile acids) are excreted through the biliary system.
Two clinical trials (Study 1 and Study 2) in adults compared CLINOLIPID injection to a pure soybean oil based intravenous lipid emulsion. Although Study 1 and Study 2 were not adequately designed to demonstrate noninferiority of CLINOLIPID injection to the soybean oil comparator, they support CLINOLIPID injection as a source of calories and essential fatty acids in adults. The lipid dosage was variable in Studies 1 and 2 and adjusted to the patient's nutritional requirements.
Study 1 was a randomized, open-label, multicenter study. Forty eight (48) patients, aged 17 to 75 years, requiring ≥ 15 days (mean 22 days) exclusive parenteral nutrition (TPN) were enrolled and randomized to either CLINOLIPID injection or a pure soybean oil based intravenous lipid emulsion. Nutritional efficacy was assessed by anthropometric indices (body weight, arm circumference, skin-fold thickness), biomarkers of protein metabolism (total protein, albumin) and lipid metabolism. Anthropometric criteria (body weight, arm circumference, and skin fold thickness) were comparable for both groups. Mean total serum protein and albumin increased similarly in both groups.
Study 2 was a randomized, open label multicenter study that enrolled 22 patients aged 32-81 years who required long-term parenteral nutrition. Twelve patients received CLINOLIPID injection for a mean of 202 days (range 24-408 days) and 10 patients received the comparator lipid for a mean of 145 days (range 29394 days). The two groups had similar outcomes for weight, weight loss, mid-arm circumference and triceps skinfold thickness.
2. Clayton P T, Whitfield P, Iyer K. The Role of Phytosterols in the Pathogenesis of Liver Complications of Pediatric Parenteral Nutrition, Nutrition, Volume 14, Issue 1, January 1998, Pages 158-164
Last reviewed on RxList: 10/18/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Clinolipid Information
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