Fenofibrate therapy to lower serum triglyceride concentrations in persons with spinal cord injury: A preliminary analysis of its safety profile

References

• Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). J Am Med Assoc. 2001;285:2486–97.
   PubMed Web of Science ®Google Scholar
• Taylor F, Huffman MD, Macedo AF, Moore TH, Burke M, Davey Smith G, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2013;1:CD004816.
   PubMed Web of Science ®Google Scholar
• Talavera JO, Martinez G, Cervantes JL, Marin JA, Rodriguez-Briones I, Gonzalez JG, et al. A double-blind, double-dummy, randomized, placebo-controlled trial to evaluate the effect of statin therapy on triglyceride levels in Mexican hypertriglyceridemic patients. Curr Med Res Opin. 2013;29(4):379–86.
   PubMed Web of Science ®Google Scholar
• Saito Y, Yamada N, Shirai K, Sasaki J, Ebihara Y, Yanase T, et al. Effect of rosuvastatin 5–20 mg on triglycerides and other lipid parameters in Japanese patients with hypertriglyceridemia. Atherosclerosis. 2007;194(2):505–11.
   PubMed Web of Science ®Google Scholar
• Stein EA, Lane M, Laskarzewski P. Comparison of statins in hypertriglyceridemia. Am J Cardiol. 1998;81(Suppl. 4A):66B–9B.
   PubMed Web of Science ®Google Scholar
• Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25 Pt B):2889–934.
   PubMed Web of Science ®Google Scholar
• Bauman WA, Adkins RH, Spungen AM, Waters RL. The effect of residual neurological deficit on oral glucose tolerance in persons with chronic spinal cord injury. Spinal Cord. 1999;37(11):765–71.
   PubMed Web of Science ®Google Scholar
• Bauman WA, Spungen AM. Disorders of carbohydrate and lipid metabolism in veterans with paraplegia or quadriplegia: a model of premature aging. Metabolism. 1994;43(6):749–56.
   PubMed Web of Science ®Google Scholar
• Bauman WA, Spungen AM. Metabolic changes in persons after spinal cord injury. Phys Med Rehabil Clin N Am. 2000;11(1):109–40.
   PubMedGoogle Scholar
• Bauman WA, Spungen AM. Carbohydrate and lipid metabolism in chronic spinal cord injury. J Spinal Cord Med. 2001;24(4):266–77.
   PubMedGoogle Scholar
• Bauman WA, Spungen AM. Body composition in aging: adverse changes in able-bodied persons and in those with spinal cord injury. Top Spinal Cord Inj Rehabil. 2001;6(3):22–36.
   Google Scholar
• de Groot S, Dallmeijer AJ, Post MW, Angenot EL, van der Woude LH. The longitudinal relationship between lipid profile and physical capacity in persons with a recent spinal cord injury. Spinal Cord. 2008;46(5):344–51.
   PubMed Web of Science ®Google Scholar
• Maki KC, Briones ER, Langbein WE, Inman-Felton A, Nemchausky B, Welch M, et al. Associations between serum lipids and indicators of adiposity in men with spinal cord injury. Paraplegia. 1995;33(2):102–9.
   PubMedGoogle Scholar
• Wang YH, Chen SY, Wang TD, Hwang BS, Huang TS, Su TC. The relationships among serum glucose, albumin concentrations and carotid atherosclerosis in men with spinal cord injury. Atherosclerosis. 2009;206(2):528–34.
   PubMed Web of Science ®Google Scholar
• Zhong YG, Levy E, Bauman WA. The relationships among serum uric acid, plasma insulin, and serum lipoprotein levels in subjects with spinal cord injury. Horm Metab Res. 1995;27(6):283–6.
   PubMed Web of Science ®Google Scholar
• Bauman WA, Adkins RH, Spungen AM, Herbert R, Schechter C, Smith D, et al. Is immobilization associated with an abnormal lipoprotein profile? Observations from a diverse cohort. Spinal Cord. 1999;37(7):485–93.
   PubMed Web of Science ®Google Scholar
• Bauman WA, Spungen AM, Wang J, Pierson RN, Jr. The relationship between energy expenditure and lean tissue in monozygotic twins discordant for spinal cord injury. J Rehabil Res Dev. 2004;41(1):1–8.
   PubMed Web of Science ®Google Scholar
• Gilbert O, Croffoot JR, Taylor AJ, Nash MS, Schomer K, Groah SL. Serum lipid concentrations among persons with spinal cord injury- A systematic review and meta-analysis of the literature. Atherosclerosis. 2014;232:305–12.
   PubMed Web of Science ®Google Scholar
• La Fountaine MF, Cirnigliaro CM, Emmons RE, Kirshblum SC, Galea M, Spungen AM, et al. Lipoprotein heterogeneity in persons with spinal cord injury: a model of prolonged sitting and restricted physical activity. Lipids Health Dis. 2015;14:81.
   PubMed Web of Science ®Google Scholar
• Zlotolow SP, Levy E, Bauman WA. The serum lipoprotein profile in veterans with paraplegia: the relationship to nutritional factors and body mass index. J Am Paraplegia Soc. 1992;15(3):158–62.
   PubMedGoogle Scholar
• Garshick E, Kelley A, Cohen SA, Garrison A, Tun CG, Gagnon D, et al. A prospective assessment of mortality in chronic spinal cord injury. Spinal Cord. 2005;43(7):408–16.
   PubMed Web of Science ®Google Scholar
• Wahman K, Nash MS, Lewis JE, Seiger A, Levi R. Increased cardiovascular disease risk in Swedish persons with paraplegia: The Stockholm spinal cord injury study. J Rehabil Med. 2010;42(5):489–92.
   PubMed Web of Science ®Google Scholar
• DeVivo MJ, Shewchuk RM, Stover SL, Black KJ, Go BK. A cross-sectional study of the relationship between age and current health status for persons with spinal cord injuries. Paraplegia. 1992;30(12):820–7.
   PubMedGoogle Scholar
• Savic G, DeVivo MJ, Frankel HL, Jamous MA, Soni BM, Charlifue S. Causes of death after traumatic spinal cord injury-a 70-year British study. Spinal Cord. 2017;55(10):891–7.
   PubMed Web of Science ®Google Scholar
• La Fountaine MF, Cirnigliaro CM, Kirshblum SC, McKenna C, Bauman WA. Effect of functional sympathetic nervous system impairment of the liver and abdominal visceral adipose tissue on circulating triglyceride-rich lipoproteins. PLoS One. 2017;12(3):e0173934.
   PubMed Web of Science ®Google Scholar
• Shimazu T. Innervation of the liver and glucoregulation: roles of the hypothalamus and autonomic nerves. Nutrition. 1996;12(1):65–6.
   PubMed Web of Science ®Google Scholar
• Jungermann K, Stumpel F. Role of hepatic, intrahepatic and hepatoenteral nerves in the regulation of carbohydrate metabolism and hemodynamics of the liver and intestine. Hepato-Gastroenterol. 1999;46(Suppl 2):1414–7.
   PubMedGoogle Scholar
• Third Report of the National Cholesterol Education Program (NCEP). Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143–421.
   PubMed Web of Science ®Google Scholar
• La Fountaine MF, Cirnigliaro CM, Hobson JC, Dyson-Hudson TA, Mc Kenna C, Kirshblum SC, et al. Establishing a threshold to predict risk of cardiovascular disease from teh serum triglyceride and high-density lipoprotein concentraions in person with spinal cord injury. Spinal Cord. 2018;56(11):1051–8.
   PubMed Web of Science ®Google Scholar
• Gotto AM J, Brinton EA. Assessing low levels of high-density lipoprotein cholesterol as a risk factor in coronary heart disease: a working group report and update. J Am Coll Cardiol. 2004;43(5):717–24.
   PubMed Web of Science ®Google Scholar
• Staels B, Dallongeville J, Auwerx J, Schoonjans K, Leitersdorf E, Fruchart JC. Mechanism of action of fibrates on lipid and lipoprotein metabolism. Circulation. 1998;98(19):2088–93.
   PubMed Web of Science ®Google Scholar
• Torra IP, Chinetti G, Duval C, Fruchart JC, Staels B. Peroxisome proliferator-activated receptors: from transcriptional control to clinical practice. Curr Opin Lipidol. 2001;12(3):245–54.
   PubMed Web of Science ®Google Scholar
• Braissant O, Foufelle F, Scotto C, Dauca M, Wahli W. Differential expression of peroxisome proliferator-activated receptors (PPARs): tissue distribution of PPAR-alpha, -beta, and -gamma in the adult rat. Endocrinol. 1996;137(1):354–66.
   PubMed Web of Science ®Google Scholar
• Auboeuf D, Rieusset J, Fajas L, Vallier P, Frering V, Riou JP, et al. Tissue distribution and quantification of the expression of mRNAs of peroxisome proliferator-activated receptors and liver X receptor-alpha in humans: no alteration in adipose tissue of obese and NIDDM patients. Diabetes. 1997;46(8):1319–27.
   PubMed Web of Science ®Google Scholar
• Schoonjans K, Staels B, Auwerx J. Role of the peroxisome proliferator-activated receptor (PPAR) in mediating the effects of fibrates and fatty acids on gene expression. J Lipid Res. 1996;37(5):907–25.
   PubMed Web of Science ®Google Scholar
• Heller F, Harvengt C. Effects of clofibrate, bezafibrate, fenofibrate and probucol on plasma lipolytic enzymes in normolipaemic subjects. Eur J Clin Pharmacol. 1983;25(1):57–63.
   PubMed Web of Science ®Google Scholar
• Fielding CJ, Fielding PE. Molecular physiology of reverse cholesterol transport. J Lipid Res. 1995;36(2):211–28.
   PubMed Web of Science ®Google Scholar
• Vu-Dac N, Chopin-Delannoy S, Gervois P, Bonnelye E, Martin G, Fruchart JC, et al. The nuclear receptors peroxisome proliferator-activated receptor alpha and Rev-erbalpha mediate the species-specific regulation of apolipoprotein A-I expression by fibrates. J Biol Chem. 1998;273(40):25713–20.
   PubMed Web of Science ®Google Scholar
• Vu-Dac N, Schoonjans K, Kosykh V, Dallongeville J, Fruchart JC, Staels B, et al. Fibrates increase human apolipoprotein A-II expression through activation of the peroxisome proliferator-activated receptor. J Clin Invest. 1995;96(2):741–50.
   PubMed Web of Science ®Google Scholar
• Miller M, Stone NJ, Ballantyne C, Bittner V, Criqui MH, Ginsberg HN, et al. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011;123(20):2292–333.
   PubMed Web of Science ®Google Scholar
• Ischaemic heart disease: a secondary prevention trial using clofibrate. Report by a research committee of the Scottish Society of Physicians. Br Med J. 1971;4(5790):775–84.
   PubMedGoogle Scholar
• Trial of clofibrate in the treatment of ischaemic heart disease. Five-year study by a group of physicians of the Newcastle upon Tyne region. Br Med J. 1971;4(5790):767–75.
   PubMedGoogle Scholar
• A co-operative trial in the primary prevention of ischaemic heart disease using clofibrate. Report from the Committee of Principal Investigators. Br Heart J. 1978;40(10):1069–118.
   PubMedGoogle Scholar
• Frick MH, Elo O, Haapa K, Heinonen OP, Heinsalmi P, Helo P, et al. Helsinki heart study: primary-prevention trial with gemfibrozil in middle-aged men with dyslipidemia. safety of treatment, changes in risk factors, and incidence of coronary heart disease. N Engl J Med. 1987;317(20):1237–45.
   PubMed Web of Science ®Google Scholar
• Manninen V, Elo MO, Frick MH, Haapa K, Heinonen OP, Heinsalmi P, et al. Lipid alterations and decline in the incidence of coronary heart disease in the Helsinki heart study. J Am Med Assoc. 1988;260(5):641–51.
   PubMed Web of Science ®Google Scholar
• Tenkanen L, Manttari M, Kovanen PT, Virkkunen H, Manninen V. Gemfibrozil in the treatment of dyslipidemia: an 18-year mortality follow-up of the Helsinki heart study. Arch Intern Med. 2006;166(7):743–8.
   PubMedGoogle Scholar
• Tenkanen L, Manttari M, Manninen V. Some coronary risk factors related to the insulin resistance syndrome and treatment with gemfibrozil. experience from the Helsinki heart study. Circulation. 1995;92(7):1779–85.
   PubMed Web of Science ®Google Scholar
• Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam MB, et al. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans affairs high-density lipoprotein cholesterol intervention trial study group. N Engl J Med. 1999;341(6):410–8.
   PubMed Web of Science ®Google Scholar
• Knopp RH, Brown WV, Dujovne CA, Farquhar JW, Feldman EB, Goldberg AC, et al. Effects of fenofibrate on plasma lipoproteins in hypercholesterolemia and combined hyperlipidemia. Am J Med. 1987;83(5B):50–9.
   PubMed Web of Science ®Google Scholar
• Mellies MJ, Stein EA, Khoury P, Lamkin G, Glueck CJ. Effects of fenofibrate on lipids, lipoproteins, and apolipoproteins in 33 subjects with primary hypercholesterolemia. Atherosclerosis. 1987;63(1):57–64.
   PubMed Web of Science ®Google Scholar
• Jakob T, Nordmann AJ, Schandelmaier S, Ferreira-Gonzalez I, Briel M. Fibrates for primary prevention of cardiovascular disease events. Cochrane Database Syst Rev. 2016;11:CD009753.
   PubMedGoogle Scholar
• Brown WV, Dujovne CA, Farquhar JW, Feldman EB, Grundy SM, Knopp RH, et al. Effects of fenofibrate on plasma lipids. Double-blind, multicenter study in patients with type IIA or IIB hyperlipidemia. Arteriosclerosis. 1986;6(6):670–8.
   PubMedGoogle Scholar
• Effect of fenofibrate on progression of coronary-artery disease in type 2 diabetes: the diabetes atherosclerosis intervention study, a randomised study. Lancet. 2001;357(9260):905–10.
   Google Scholar
• Keech A, Simes RJ, Barter P, Best J, Scott R, Taskinen MR, et al. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005;366(9500):1849–61.
   PubMed Web of Science ®Google Scholar
• Rosenson RS, Wolff DA, Huskin AL, Helenowski IB, Rademaker AW. Fenofibrate therapy ameliorates fasting and postprandial lipoproteinemia, oxidative stress, and the inflammatory response in subjects with hypertriglyceridemia and the metabolic syndrome. Diabetes Care. 2007;30(8):1945–51.
   PubMed Web of Science ®Google Scholar
• Physician's Desk Reference. ed. Montvale (NJ): PDR, LLC; 2018.
   Google Scholar
• Blane GF. Comparative toxicity and safety profile of fenofibrate and other fibric acid derivatives. Am J Med. 1987;83(5B):26–36.
   PubMed Web of Science ®Google Scholar
• Kirshblum SC, Burns SP, Biering-Sorensen F, Donovan W, Graves DE, Jha A, et al. International standards for neurological classification of spinal cord injury (revised 2011). J Spinal Cord Med. 2011;34(6):535–46.
   PubMed Web of Science ®Google Scholar
• Coggrave M, Norton C, Wilson-Barnett J. Management of neurogenic bowel dysfunction in the community after spinal cord injury: a postal survey in the United Kingdom. Spinal Cord. 2009;47:323–30.
   PubMed Web of Science ®Google Scholar