Clinical Trial to Evaluate the Efficacy of a Dyslipidemic Therapy in Mexican Population

Summary

Clinical Trial Phase III, experimental, simple blind, randomized with two treatment groups, multicentric, longitudinal, to evaluate the therapuetic efficacy to dislipydemias in mexican adult population. This trial includes homogeneus populations that could be comparable by their disease condition, biologic characteristics and sociodemographics characteristics. 2 Treatment groups: Experimental Group: Oral Administration of L-carnitine (1g) + Oral Atorvastatin (20mg), every 24 hours for 6 months. Active control group: Oral Administration of Atorvastatin 20mg every 24 hours for 6 months. Sample Size: 120 subjects, females or males between 35 to 75 years old. Laboratory tests: Hematic biometry, quimical blood components, electrocardiogram and pregnancy urinary test.

Timeline

Start

2018-05-28

Primary completion

2019-03-01

Completion

2019-08-31

Publications

• Results Bou Malham S, Goldberg AC. Cardiovascular risk reduction: the future of cholesterol lowering drugs. Curr Opin Pharmacol. 2016 Apr;27:62-9. doi: 10.1016/j.coph.2016.01.007. Epub 2016 Mar 2.
• Results Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available.
• Results Rosenson RS, Baker SK, Jacobson TA, Kopecky SL, Parker BA, The National Lipid Association's Muscle Safety Expert Panel. An assessment by the Statin Muscle Safety Task Force: 2014 update. J Clin Lipidol. 2014 May-Jun;8(3 Suppl):S58-71. doi: 10.1016/j.jacl.2014.03.004.
• Results Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 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 Jul 1;63(25 Pt B):2889-934. doi: 10.1016/j.jacc.2013.11.002. Epub 2013 Nov 12. No abstract available.
• Results Lee BJ, Lin JS, Lin YC, Lin PT. Effects of L-carnitine supplementation on lipid profiles in patients with coronary artery disease. Lipids Health Dis. 2016 Jun 17;15:107. doi: 10.1186/s12944-016-0277-5.
• Results Chawla A, Repa JJ, Evans RM, Mangelsdorf DJ. Nuclear receptors and lipid physiology: opening the X-files. Science. 2001 Nov 30;294(5548):1866-70. doi: 10.1126/science.294.5548.1866.
• Results Barter PJ, Rye KA. Relationship between the concentration and antiatherogenic activity of high-density lipoproteins. Curr Opin Lipidol. 2006 Aug;17(4):399-403. doi: 10.1097/01.mol.0000236365.40969.af.
• Results Cooney MT, Dudina A, De Bacquer D, Wilhelmsen L, Sans S, Menotti A, De Backer G, Jousilahti P, Keil U, Thomsen T, Whincup P, Graham IM; SCORE investigators. HDL cholesterol protects against cardiovascular disease in both genders, at all ages and at all levels of risk. Atherosclerosis. 2009 Oct;206(2):611-6. doi: 10.1016/j.atherosclerosis.2009.02.041. Epub 2009 Mar 19.
• Results Anderson TJ, Gregoire J, Hegele RA, Couture P, Mancini GB, McPherson R, Francis GA, Poirier P, Lau DC, Grover S, Genest J Jr, Carpentier AC, Dufour R, Gupta M, Ward R, Leiter LA, Lonn E, Ng DS, Pearson GJ, Yates GM, Stone JA, Ur E. 2012 update of the Canadian Cardiovascular Society guidelines for the diagnosis and treatment of dyslipidemia for the prevention of cardiovascular disease in the adult. Can J Cardiol. 2013 Feb;29(2):151-67. doi: 10.1016/j.cjca.2012.11.032.
• Results Wadhera RK, Steen DL, Khan I, Giugliano RP, Foody JM. A review of low-density lipoprotein cholesterol, treatment strategies, and its impact on cardiovascular disease morbidity and mortality. J Clin Lipidol. 2016 May-Jun;10(3):472-89. doi: 10.1016/j.jacl.2015.11.010. Epub 2015 Nov 25.
• Results National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). 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 Dec 17;106(25):3143-421. No abstract available.
• Results Aguilar-Salinas CA, Canizales-Quinteros S, Rojas-Martinez R, Garcia-Garcia E, Olaiz-Fernandez G, Gomez-Perez FJ, Tusie-Luna MT. [Succesful collaborations between three Mexican institutions for research on dislipidemias, obesity and diabetes]. Gac Med Mex. 2007 Sep-Oct;143(5):355-64. Spanish.
• Results Escobedo-de la Pena J, de Jesus-Perez R, Schargrodsky H, Champagne B. [Prevalence of dyslipidemias in Mexico city and Its relation to other cardiovascular risk factors. Results from the CARMELA study]. Gac Med Mex. 2014 Mar-Apr;150(2):128-36. Spanish.
• Results Aguilar Salinas CA, Zamora M, Gomez-Diaz RA, Mehta R, Gomez Perez FJ, Rull JA. Familial combined hyperlipidemia: controversial aspects of its diagnosis and pathogenesis. Semin Vasc Med. 2004 May;4(2):203-9. doi: 10.1055/s-2004-835379.
• Results Badzioch MD, Igo RP Jr, Gagnon F, Brunzell JD, Krauss RM, Motulsky AG, Wijsman EM, Jarvik GP. Low-density lipoprotein particle size loci in familial combined hyperlipidemia: evidence for multiple loci from a genome scan. Arterioscler Thromb Vasc Biol. 2004 Oct;24(10):1942-50. doi: 10.1161/01.ATV.0000143499.09575.93. Epub 2004 Aug 26.
• Results Sniderman AD, Castro Cabezas M, Ribalta J, Carmena R, de Bruin TW, de Graaf J, Erkelens DW, Humphries SE, Masana L, Real JT, Talmud PJ, Taskinen MR. A proposal to redefine familial combined hyperlipidaemia -- third workshop on FCHL held in Barcelona from 3 to 5 May 2001, during the scientific sessions of the European Society for Clinical Investigation. Eur J Clin Invest. 2002 Feb;32(2):71-3. doi: 10.1046/j.1365-2362.2002.00941.x. No abstract available.
• Results Veerkamp MJ, de Graaf J, Bredie SJ, Hendriks JC, Demacker PN, Stalenhoef AF. Diagnosis of familial combined hyperlipidemia based on lipid phenotype expression in 32 families: results of a 5-year follow-up study. Arterioscler Thromb Vasc Biol. 2002 Feb 1;22(2):274-82. doi: 10.1161/hq0202.104059.
• Results Sullivan DR, Hamilton-Craig I, van Bockxmeer F, Watts GF; CSANZ Cardiac Genetics Diseases Council Writing Group. INTERIM guidelines for the diagnosis and management of familial hypercholesterolaemia. Heart Lung Circ. 2012 Mar;21(3):159-62. doi: 10.1016/j.hlc.2011.11.006. Epub 2012 Jan 30. No abstract available.
• Results Alonso R, Castillo S, Civeira F, Puzo J, de la Cruz JJ, Pocovi M, Mata P. [Heterozygous familial hypercholesterolemia in Spain. Description of 819 non related cases]. Med Clin (Barc). 2002 Apr 13;118(13):487-92. doi: 10.1016/s0025-7753(02)72428-7. Spanish.
• Results Blom DJ, O'Neill FH, Marais AD. Screening for dysbetalipoproteinemia by plasma cholesterol and apolipoprotein B concentrations. Clin Chem. 2005 May;51(5):904-7. doi: 10.1373/clinchem.2004.047001. No abstract available.
• Results Cohen JC, Boerwinkle E, Mosley TH Jr, Hobbs HH. Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. N Engl J Med. 2006 Mar 23;354(12):1264-72. doi: 10.1056/NEJMoa054013.
• Results Abifadel M, Varret M, Rabes JP, Allard D, Ouguerram K, Devillers M, Cruaud C, Benjannet S, Wickham L, Erlich D, Derre A, Villeger L, Farnier M, Beucler I, Bruckert E, Chambaz J, Chanu B, Lecerf JM, Luc G, Moulin P, Weissenbach J, Prat A, Krempf M, Junien C, Seidah NG, Boileau C. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia. Nat Genet. 2003 Jun;34(2):154-6. doi: 10.1038/ng1161.
• Results Garcia CK, Wilund K, Arca M, Zuliani G, Fellin R, Maioli M, Calandra S, Bertolini S, Cossu F, Grishin N, Barnes R, Cohen JC, Hobbs HH. Autosomal recessive hypercholesterolemia caused by mutations in a putative LDL receptor adaptor protein. Science. 2001 May 18;292(5520):1394-8. doi: 10.1126/science.1060458. Epub 2001 Apr 26.
• Results Vodnala D, Rubenfire M, Brook RD. Secondary causes of dyslipidemia. Am J Cardiol. 2012 Sep 15;110(6):823-5. doi: 10.1016/j.amjcard.2012.04.062. Epub 2012 Jun 2.
• Results Vaziri ND. Disorders of lipid metabolism in nephrotic syndrome: mechanisms and consequences. Kidney Int. 2016 Jul;90(1):41-52. doi: 10.1016/j.kint.2016.02.026. Epub 2016 Apr 26.
• Results de Jager DJ, Grootendorst DC, Jager KJ, van Dijk PC, Tomas LM, Ansell D, Collart F, Finne P, Heaf JG, De Meester J, Wetzels JF, Rosendaal FR, Dekker FW. Cardiovascular and noncardiovascular mortality among patients starting dialysis. JAMA. 2009 Oct 28;302(16):1782-9. doi: 10.1001/jama.2009.1488.
• Results Glass TR, Ungsedhapand C, Wolbers M, Weber R, Vernazza PL, Rickenbach M, Furrer H, Bernasconi E, Cavassini M, Hirschel B, Battegay M, Bucher HC; Swiss HIV Cohort Study. Prevalence of risk factors for cardiovascular disease in HIV-infected patients over time: the Swiss HIV Cohort Study. HIV Med. 2006 Sep;7(6):404-10. doi: 10.1111/j.1468-1293.2006.00400.x.
• Results Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs RH, Kjekshus JK, Perrone Filardi P, Riccardi G, Storey RF, David W; Clinical Practice Guidelines Committee of the Spanish Society of Cardiology. [ESC/EAS Guidelines for the management of dyslipidaemias]. Rev Esp Cardiol. 2011 Dec;64(12):1168.e1-1168.e60. doi: 10.1016/j.recesp.2011.09.014. No abstract available. Spanish.
• Results Bays HE, Jones PH, Orringer CE, Brown WV, Jacobson TA. National Lipid Association Annual Summary of Clinical Lipidology 2016. J Clin Lipidol. 2016 Jan-Feb;10(1 Suppl):S1-43. doi: 10.1016/j.jacl.2015.08.002.
• Results Levenson JW, Skerrett PJ, Gaziano JM. Reducing the global burden of cardiovascular disease: the role of risk factors. Prev Cardiol. 2002 Fall;5(4):188-99. doi: 10.1111/j.1520-037x.2002.00564.x.
• Results Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB Sr, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC Jr, Sorlie P, Stone NJ, Wilson PWF. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2935-2959. doi: 10.1016/j.jacc.2013.11.005. Epub 2013 Nov 12. No abstract available.
• Results Austin MA, McKnight B, Edwards KL, Bradley CM, McNeely MJ, Psaty BM, Brunzell JD, Motulsky AG. Cardiovascular disease mortality in familial forms of hypertriglyceridemia: A 20-year prospective study. Circulation. 2000 Jun 20;101(24):2777-82. doi: 10.1161/01.cir.101.24.2777.
• Results Blair HC, Sepulveda J, Papachristou DJ. Nature and nurture in atherosclerosis: The roles of acylcarnitine and cell membrane-fatty acid intermediates. Vascul Pharmacol. 2016 Mar;78:17-23. doi: 10.1016/j.vph.2015.06.012. Epub 2015 Jun 30.
• Results Stamler J, Neaton JD. The Multiple Risk Factor Intervention Trial (MRFIT)--importance then and now. JAMA. 2008 Sep 17;300(11):1343-5. doi: 10.1001/jama.300.11.1343. No abstract available.
• Results Acosta-Cazares B, Escobedo-de la Pena J. High burden of cardiovascular disease risk factors in Mexico: An epidemic of ischemic heart disease that may be on its way? Am Heart J. 2010 Aug;160(2):230-6. doi: 10.1016/j.ahj.2010.05.016.
• Results Schaefer EJ, Levy RI. Pathogenesis and management of lipoprotein disorders. N Engl J Med. 1985 May 16;312(20):1300-10. doi: 10.1056/NEJM198505163122007. No abstract available.
• Results Lloyd-Jones DM, Leip EP, Larson MG, D'Agostino RB, Beiser A, Wilson PW, Wolf PA, Levy D. Prediction of lifetime risk for cardiovascular disease by risk factor burden at 50 years of age. Circulation. 2006 Feb 14;113(6):791-8. doi: 10.1161/CIRCULATIONAHA.105.548206. Epub 2006 Feb 6.
• Results Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.
• Results Hajifathalian K, Ueda P, Lu Y, Woodward M, Ahmadvand A, Aguilar-Salinas CA, Azizi F, Cifkova R, Di Cesare M, Eriksen L, Farzadfar F, Ikeda N, Khalili D, Khang YH, Lanska V, Leon-Munoz L, Magliano D, Msyamboza KP, Oh K, Rodriguez-Artalejo F, Rojas-Martinez R, Shaw JE, Stevens GA, Tolstrup J, Zhou B, Salomon JA, Ezzati M, Danaei G. A novel risk score to predict cardiovascular disease risk in national populations (Globorisk): a pooled analysis of prospective cohorts and health examination surveys. Lancet Diabetes Endocrinol. 2015 May;3(5):339-55. doi: 10.1016/S2213-8587(15)00081-9. Epub 2015 Mar 26.
• Results Bays HE. A lipidologist perspective of global lipid guidelines and recommendations, part 2: Lipid treatment goals. J Clin Lipidol. 2016 Mar-Apr;10(2):240-64. doi: 10.1016/j.jacl.2015.11.006. Epub 2015 Dec 2.
• Results Bouhairie VE, Goldberg AC. Familial Hypercholesterolemia. Endocrinol Metab Clin North Am. 2016 Mar;45(1):1-16. doi: 10.1016/j.ecl.2015.09.001.
• Results Hopkins PN, Toth PP, Ballantyne CM, Rader DJ; National Lipid Association Expert Panel on Familial Hypercholesterolemia. Familial hypercholesterolemias: prevalence, genetics, diagnosis and screening recommendations from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidol. 2011 Jun;5(3 Suppl):S9-17. doi: 10.1016/j.jacl.2011.03.452. Epub 2011 Apr 3. No abstract available.
• Results Miller M, Cannon CP, Murphy SA, Qin J, Ray KK, Braunwald E; PROVE IT-TIMI 22 Investigators. Impact of triglyceride levels beyond low-density lipoprotein cholesterol after acute coronary syndrome in the PROVE IT-TIMI 22 trial. J Am Coll Cardiol. 2008 Feb 19;51(7):724-30. doi: 10.1016/j.jacc.2007.10.038.
• Results Zhao D, Liu J, Xie W, Qi Y. Cardiovascular risk assessment: a global perspective. Nat Rev Cardiol. 2015 May;12(5):301-11. doi: 10.1038/nrcardio.2015.28. Epub 2015 Mar 10.
• Results Sheridan SL, Viera AJ, Krantz MJ, Ice CL, Steinman LE, Peters KE, Kopin LA, Lungelow D; Cardiovascular Health Intervention Research and Translation Network Work Group on Global Coronary Heart Disease Risk. The effect of giving global coronary risk information to adults: a systematic review. Arch Intern Med. 2010 Feb 8;170(3):230-9. doi: 10.1001/archinternmed.2009.516.
• Results Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.
• Results Kraus WE, Houmard JA, Duscha BD, Knetzger KJ, Wharton MB, McCartney JS, Bales CW, Henes S, Samsa GP, Otvos JD, Kulkarni KR, Slentz CA. Effects of the amount and intensity of exercise on plasma lipoproteins. N Engl J Med. 2002 Nov 7;347(19):1483-92. doi: 10.1056/NEJMoa020194.
• Results Lozano P, Henrikson NB, Morrison CC, Dunn J, Nguyen M, Blasi PR, Whitlock EP. Lipid Screening in Childhood and Adolescence for Detection of Multifactorial Dyslipidemia: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2016 Aug 9;316(6):634-44. doi: 10.1001/jama.2016.6423.
• Results Avis HJ, Vissers MN, Stein EA, Wijburg FA, Trip MD, Kastelein JJ, Hutten BA. A systematic review and meta-analysis of statin therapy in children with familial hypercholesterolemia. Arterioscler Thromb Vasc Biol. 2007 Aug;27(8):1803-10. doi: 10.1161/ATVBAHA.107.145151. Epub 2007 Jun 14.
• Results Robinson JG, Wang S, Jacobson TA. Meta-analysis of comparison of effectiveness of lowering apolipoprotein B versus low-density lipoprotein cholesterol and nonhigh-density lipoprotein cholesterol for cardiovascular risk reduction in randomized trials. Am J Cardiol. 2012 Nov 15;110(10):1468-76. doi: 10.1016/j.amjcard.2012.07.007. Epub 2012 Aug 17.
• Results Bays H, Cohen DE, Chalasani N, Harrison SA, The National Lipid Association's Statin Safety Task Force. An assessment by the Statin Liver Safety Task Force: 2014 update. J Clin Lipidol. 2014 May-Jun;8(3 Suppl):S47-57. doi: 10.1016/j.jacl.2014.02.011.
• Results American Diabetes Association. (8) Cardiovascular disease and risk management. Diabetes Care. 2015 Jan;38 Suppl:S49-57. doi: 10.2337/dc15-S011. No abstract available.
• Results Jacobson TA, Maki KC, Orringer CE, Jones PH, Kris-Etherton P, Sikand G, La Forge R, Daniels SR, Wilson DP, Morris PB, Wild RA, Grundy SM, Daviglus M, Ferdinand KC, Vijayaraghavan K, Deedwania PC, Aberg JA, Liao KP, McKenney JM, Ross JL, Braun LT, Ito MK, Bays HE, Brown WV, Underberg JA; NLA Expert Panel. National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 2. J Clin Lipidol. 2015 Nov-Dec;9(6 Suppl):S1-122.e1. doi: 10.1016/j.jacl.2015.09.002. Epub 2015 Sep 18.
• Results Ble A, Hughes PM, Delgado J, Masoli JA, Bowman K, Zirk-Sadowski J, Mujica Mota RE, Henley WE, Melzer D. Safety and Effectiveness of Statins for Prevention of Recurrent Myocardial Infarction in 12 156 Typical Older Patients: A Quasi-Experimental Study. J Gerontol A Biol Sci Med Sci. 2017 Feb;72(2):243-250. doi: 10.1093/gerona/glw082. Epub 2016 May 4.
• Results Writing Committee; Lloyd-Jones DM, Morris PB, Ballantyne CM, Birtcher KK, Daly DD Jr, DePalma SM, Minissian MB, Orringer CE, Smith SC Jr. 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol. 2016 Jul 5;68(1):92-125. doi: 10.1016/j.jacc.2016.03.519. Epub 2016 Apr 1. No abstract available.
• Results Kellick KA, Bottorff M, Toth PP, The National Lipid Association's Safety Task Force. A clinician's guide to statin drug-drug interactions. J Clin Lipidol. 2014 May-Jun;8(3 Suppl):S30-46. doi: 10.1016/j.jacl.2014.02.010.
• Results Paiva H, Thelen KM, Van Coster R, Smet J, De Paepe B, Mattila KM, Laakso J, Lehtimaki T, von Bergmann K, Lutjohann D, Laaksonen R. High-dose statins and skeletal muscle metabolism in humans: a randomized, controlled trial. Clin Pharmacol Ther. 2005 Jul;78(1):60-8. doi: 10.1016/j.clpt.2005.03.006.
• Results Parker BA, Capizzi JA, Grimaldi AS, Clarkson PM, Cole SM, Keadle J, Chipkin S, Pescatello LS, Simpson K, White CM, Thompson PD. Effect of statins on skeletal muscle function. Circulation. 2013 Jan 1;127(1):96-103. doi: 10.1161/CIRCULATIONAHA.112.136101. Epub 2012 Nov 26.
• Results Apostolopoulou M, Corsini A, Roden M. The role of mitochondria in statin-induced myopathy. Eur J Clin Invest. 2015 Jul;45(7):745-54. doi: 10.1111/eci.12461. Epub 2015 Jun 15.
• Results Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010 Feb 27;375(9716):735-42. doi: 10.1016/S0140-6736(09)61965-6. Epub 2010 Feb 16.
• Results Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM; IMPROVE-IT Investigators. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015 Jun 18;372(25):2387-97. doi: 10.1056/NEJMoa1410489. Epub 2015 Jun 3.
• Results Ross S, D'Mello M, Anand SS, Eikelboom J; CARDIoGRAMplusC4D Consortium; Stewart AF, Samani NJ, Roberts R, Pare G. Effect of Bile Acid Sequestrants on the Risk of Cardiovascular Events: A Mendelian Randomization Analysis. Circ Cardiovasc Genet. 2015 Aug;8(4):618-27. doi: 10.1161/CIRCGENETICS.114.000952. Epub 2015 Jun 4.
• Results 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 May;37(5):907-25.
• Results Stanulovic V, Deric M, Popovic J. [Clinical trials of statins and fibrates --a meta-analysis]. Med Pregl. 2006 May-Jun;59(5-6):213-8. doi: 10.2298/mpns0606213s. Serbian.
• Results Navarese EP, Kolodziejczak M, Schulze V, Gurbel PA, Tantry U, Lin Y, Brockmeyer M, Kandzari DE, Kubica JM, D'Agostino RB Sr, Kubica J, Volpe M, Agewall S, Kereiakes DJ, Kelm M. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 Antibodies in Adults With Hypercholesterolemia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Jul 7;163(1):40-51. doi: 10.7326/M14-2957.
• Results Brass EP. Supplemental carnitine and exercise. Am J Clin Nutr. 2000 Aug;72(2 Suppl):618S-23S. doi: 10.1093/ajcn/72.2.618S.
• Results Serban MC, Sahebkar A, Mikhailidis DP, Toth PP, Jones SR, Muntner P, Blaha MJ, Andrica F, Martin SS, Borza C, Lip GY, Ray KK, Rysz J, Hazen SL, Banach M. Impact of L-carnitine on plasma lipoprotein(a) concentrations: A systematic review and meta-analysis of randomized controlled trials. Sci Rep. 2016 Jan 12;6:19188. doi: 10.1038/srep19188.
• Results Naini AE, Sadeghi M, Mortazavi M, Moghadasi M, Harandi AA. Oral carnitine supplementation for dyslipidemia in chronic hemodialysis patients. Saudi J Kidney Dis Transpl. 2012 May;23(3):484-8.
• Results Emami Naini A, Moradi M, Mortazavi M, Amini Harandi A, Hadizadeh M, Shirani F, Basir Ghafoori H, Emami Naini P. Effects of Oral L-Carnitine Supplementation on Lipid Profile, Anemia, and Quality of Life in Chronic Renal Disease Patients under Hemodialysis: A Randomized, Double-Blinded, Placebo-Controlled Trial. J Nutr Metab. 2012;2012:510483. doi: 10.1155/2012/510483. Epub 2012 Jun 5.
• Results Ferrari R, Merli E, Cicchitelli G, Mele D, Fucili A, Ceconi C. Therapeutic effects of L-carnitine and propionyl-L-carnitine on cardiovascular diseases: a review. Ann N Y Acad Sci. 2004 Nov;1033:79-91. doi: 10.1196/annals.1320.007.
• Results Tiwari A, Bansal V, Chugh A, Mookhtiar K. Statins and myotoxicity: a therapeutic limitation. Expert Opin Drug Saf. 2006 Sep;5(5):651-66. doi: 10.1517/14740338.5.5.651.
• Results Anfossi G, Massucco P, Bonomo K, Trovati M. Prescription of statins to dyslipidemic patients affected by liver diseases: a subtle balance between risks and benefits. Nutr Metab Cardiovasc Dis. 2004 Aug;14(4):215-24. doi: 10.1016/s0939-4753(04)80008-5.
• Results Chatzizisis YS, Koskinas KC, Misirli G, Vaklavas C, Hatzitolios A, Giannoglou GD. Risk factors and drug interactions predisposing to statin-induced myopathy: implications for risk assessment, prevention and treatment. Drug Saf. 2010 Mar 1;33(3):171-87. doi: 10.2165/11319380-000000000-00000.
• Results Arora R, Liebo M, Maldonado F. Statin-induced myopathy: the two faces of Janus. J Cardiovasc Pharmacol Ther. 2006 Jun;11(2):105-12. doi: 10.1177/1074248406288758.
• Results Owczarek J, Jasinska M, Orszulak-Michalak D. Drug-induced myopathies. An overview of the possible mechanisms. Pharmacol Rep. 2005 Jan-Feb;57(1):23-34.
• Results Armitage J. The safety of statins in clinical practice. Lancet. 2007 Nov 24;370(9601):1781-90. doi: 10.1016/S0140-6736(07)60716-8.
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