Evaluating the safety of Liptruzet (ezetimibe and atorvastatin): what are the potential benefits beyond low-density lipoprotein cholesterol-lowering effect?

Bibliography

• McKenney JM, Jones PH, Bays HE, et al. Comparative effects on lipid levels of combination therapy with a statin and extended-release niacin or ezetimibe versus a statin alone (the COMPELL study). Atherosclerosis 2007;192(2):432-7
   PubMed Web of Science ®Google Scholar
• Goldenberg MM. Pharmaceutical approval update. P T 2013;38(11):705-7
   PubMedGoogle Scholar
• Her AY, Kim JY, Kang SM, et al. Effects of atorvastatin 20 mg, rosuvastatin 10 mg, and atorvastatin/ezetimibe 5 mg/5 mg on lipoproteins and glucose metabolism. J Cardiovasc Pharmacol Ther 2010;15(2):167-74
   PubMed Web of Science ®Google Scholar
• Dubuc G, Chamberland A, Wassef H, et al. Statins upregulate PCSK9, the gene encoding the proprotein convertase neural apoptosis-regulated convertase-1 implicated in familial hypercholesterolemia. Arterioscler Thromb Vasc Biol 2004;24(8):1454-9
   PubMed Web of Science ®Google Scholar
• Park SW, Moon YA, Horton JD. Post-transcriptional regulation of low density lipoprotein receptor protein by proprotein convertase subtilisin/kexin type 9a in mouse liver. J Biol Chem 2004;279(48):50630-8
   PubMed Web of Science ®Google Scholar
• Konrad RJ, Troutt JS, Cao G. Effects of currently prescribed LDL-C-lowering drugs on PCSK9 and implications for the next generation of LDL-C-lowering agents. Lipids Health Dis 2011;10:38
   PubMed Web of Science ®Google Scholar
• Adams SP, Tsang M, Wright JM. Lipid-lowering efficacy of atorvastatin. Cochrane Database Syst Rev 2015;3:CD008226
   Google Scholar
• Ahmed MH, Khalil AA. Ezetimibe as a potential treatment for dyslipidemia associated with chronic renal failure and renal transplant. Saudi J Kidney Dis Transpl 2010;21(6):1021-9
   PubMedGoogle Scholar
• Nutescu EA, Shapiro NL. Ezetimibe: a selective cholesterol absorption inhibitor. Pharmacotherapy 2003;23(11):1463-74
   PubMed Web of Science ®Google Scholar
• Constance C, Ben-Yehuda O, Wenger NK, et al. Atorvastatin 10 mg plus ezetimibe versus titration to atorvastatin 40 mg: attainment of European and Canadian guideline lipid targets in high-risk subjects >/=65 years. Lipids Health Dis 2014;13:13
   PubMed Web of Science ®Google Scholar
• Conard SE, Bays HE, Leiter LA, et al. Efficacy and safety of ezetimibe added on to atorvastatin (20 mg) versus uptitration of atorvastatin (to 40 mg) in hypercholesterolemic patients at moderately high risk for coronary heart disease. Am J Cardiol 2008;102(11):1489-94
   PubMed Web of Science ®Google Scholar
• Leiter LA, Bays H, Conard S, et al. Efficacy and safety of ezetimibe added on to atorvastatin (40 mg) compared with uptitration of atorvastatin (to 80 mg) in hypercholesterolemic patients at high risk of coronary heart disease. Am J Cardiol 2008;102(11):1495-501
   PubMed Web of Science ®Google Scholar
• Conard S, Bays H, Leiter LA, et al. Ezetimibe added to atorvastatin compared with doubling the atorvastatin dose in patients at high risk for coronary heart disease with diabetes mellitus, metabolic syndrome or neither. Diabetes Obes Metab 2010;12(3):210-18
   PubMed Web of Science ®Google Scholar
• Teramoto T, Sawada T, Iwamoto K, Daida H. Clinical efficacy and tolerability of Ezetimibe in combination with Atorvastatin in Japanese patients with Hypercholesterolemia-Ezetimibe Phase IV randomized controlled trial in patients with Hypercholesterolemia. Curr Ther Res Clin Exp 2012;73(1-2):16-40
   PubMed Web of Science ®Google Scholar
• Vargo R, Adewale A, Behm MO, et al. Prediction of clinical irrelevance of PK differences in atorvastatin using PK/PD models derived from literature-based meta-analyses. Clin Pharmacol Ther 2014;96(1):101-9
   PubMed Web of Science ®Google Scholar
• Blagden MD, Chipperfield R. Efficacy and safety of ezetimibe co-administered with atorvastatin in untreated patients with primary hypercholesterolaemia and coronary heart disease. Curr Med Res Opin 2007;23(4):767-75
   PubMed Web of Science ®Google Scholar
• Lee SH, Park S, Kang SM, et al. Effect of atorvastatin monotherapy and low-dose atorvastatin/ezetimibe combination on fasting and postprandial triglycerides in combined hyperlipedemia. J Cardiovasc Pharmacol Ther 2012;17(1):65-71
   PubMed Web of Science ®Google Scholar
• Weffald LA, Flach LA. Myopathy associated with atorvastatin-ezetimibe combination therapy. Pharmacotherapy 2007;27(2):309-11
   PubMed Web of Science ®Google Scholar
• Bays HE, Chen E, Tomassini JE, et al. Fixed-dose combination ezetimibe+atorvastatin lowers LDL-C equivalent to co-administered components in randomized trials: use of a dose-response model. Fundam Clin Pharmacol 2015;29(2):209-18
   PubMed Web of Science ®Google Scholar
• Yang YC, Chang WT, Huang SK, Liau I. Characterization of the pharmaceutical effect of drugs on atherosclerotic lesions in vivo using integrated fluorescence imaging and Raman spectral measurements. Anal Chem 2014;86(8):3863-8
   PubMed Web of Science ®Google Scholar
• Prasad A, Pratim Datta P, Roy R, et al. Comparative study of ezetimibe and atorvastatin alone and in combination on lipid profile in rats. Mater Sociomed 2013;25(3):192-5
   Google Scholar
• Yasim A, Ozbag D, Kilinc M, et al. Effect of atorvastatin and ezetimibe treatment on serum lipid profile and oxidative state in rats fed with a high-cholesterol diet. Am J Med Sci 2010;339(5):448-52
   PubMed Web of Science ®Google Scholar
• Matsue Y, Matsumura A, Suzuki M, et al. Differences in action of atorvastatin and ezetimibe in lowering low-density lipoprotein cholesterol and effect on endothelial function: randomized controlled trial. Circ J 2013;77(7):1791-8
   PubMed Web of Science ®Google Scholar
• Luo P, Li L, Wang LX, et al. Effects of atorvastatin in combination with ezetimibe on carotid atherosclerosis in elderly patients with hypercholesterolemia. Genet Mol Res 2014;13(2):2377-84
   PubMed Web of Science ®Google Scholar
• Lins LC, Franca CN, Fonseca FA, et al. Effects of ezetimibe on endothelial progenitor cells and microparticles in high-risk patients. Cell Biochem Biophys 2014;70(1):687-96
   PubMed Web of Science ®Google Scholar
• Stein E, Stender S, Mata P, et al. Achieving lipoprotein goals in patients at high risk with severe hypercholesterolemia: efficacy and safety of ezetimibe co-administered with atorvastatin. Am Heart J 2004;148(3):447-55
   PubMed Web of Science ®Google Scholar
• Foody JM, Toth PP, Tomassini JE, et al. Changes in LDL-C levels and goal attainment associated with addition of ezetimibe to simvastatin, atorvastatin, or rosuvastatin compared with titrating statin monotherapy. Vasc Health Risk Manag 2013;9:719-27
   PubMedGoogle Scholar
• Uemura Y, Watarai M, Ishii H, et al. Atorvastatin 10 mg plus ezetimibe 10mg compared with atorvastatin 20 mg: impact on the lipid profile in Japanese patients with abnormal glucose tolerance and coronary artery disease. J Cardiol 2012;59(1):50-6
   PubMed Web of Science ®Google Scholar
• Azar M, Valentin E, Badaoui G, et al. Comparison of the effects of combination atorvastatin (40 mg) + ezetimibe (10 mg) versus atorvastatin (40 mg) alone on secretory phospholipase A2 activity in patients with stable coronary artery disease or coronary artery disease equivalent. Am J Cardiol 2011;107(11):1571-4
   PubMed Web of Science ®Google Scholar
• Padhy BM, Yadav R, Gupta YK. Hypolipidaemic and anti-inflammatory effects of fixed dose combination of atorvastatin plus ezetimibe in Indian patients with dyslipidaemia. Singapore Med J 2013;54(2):90-5
   PubMed Web of Science ®Google Scholar
• Azar RR, Badaoui G, Sarkis A, et al. Effect of ezetimibe/atorvastatin combination on oxidized low density lipoprotein cholesterol in patients with coronary artery disease or coronary artery disease equivalent. Am J Cardiol 2010;106(2):193-7
   PubMed Web of Science ®Google Scholar
• Holvoet P, Jenny NS, Schreiner PJ, Multi-Ethnic Study of Atherosclerosis. The relationship between oxidized LDL and other cardiovascular risk factors and subclinical CVD in different ethnic groups: the Multi-Ethnic Study of Atherosclerosis (MESA). Atherosclerosis 2007;194(1):245-52
   PubMed Web of Science ®Google Scholar
• Makela KM, Traylor M, Oksala N, et al. Association of the novel single-nucleotide polymorphism which increases oxidized low-density lipoprotein levels with cerebrovascular disease events. Atherosclerosis 2014;234(1):214-17
   PubMed Web of Science ®Google Scholar
• Li L, Zhang M, Su F, et al. Combination therapy analysis of ezetimibe and statins in Chinese patients with acute coronary syndrome and type 2 diabetes. Lipids Health Dis 2015;14(1):10
   PubMed Web of Science ®Google Scholar
• Packard C. Did we IMPROVE-IT: thoughts on LDL targeting post-trial? Expert Rev Cardiovasc Ther 2015;12:1-2
   Google Scholar
• Laires PA, Ejzykowicz F, Hsu TY, et al. Cost-effectiveness of adding ezetimibe to atorvastatin vs switching to rosuvastatin therapy in Portugal. J Med Econ 2015;1-8
   PubMedGoogle Scholar
• Deushi M, Nomura M, Kawakami A, et al. Ezetimibe improves liver steatosis and insulin resistance in obese rat model of metabolic syndrome. FEBS Lett 2007;581(29):5664-70
   PubMed Web of Science ®Google Scholar
• Ichimori S, Shimoda S, Goto R, et al. Ezetimibe improves glucose metabolism by ameliorating hepatic function in Japanese patients with type 2 diabetes. J Diabetes Investig 2012;3(2):179-84
   Google Scholar
• Tamaki N, Ueno H, Morinaga Y, Shiiya T. Nakazato M. Ezetimibe ameliorates atherosclerotic and inflammatory markers, atherogenic lipid profiles, insulin sensitivity, and liver dysfunction in Japanese patients with hypercholesterolemia. J Atheroscler Thromb 2012;19(6):532-8
   PubMed Web of Science ®Google Scholar
• Ahmed MH, Ali A. Nonalcoholic fatty liver disease and cholesterol gallstones: which comes first? Scand J Gastroenterol 2014;49(5):521-7
   PubMed Web of Science ®Google Scholar
• Ahmed MH, Hamad MA, Routh C, Connolly V. Statins as potential treatment for cholesterol gallstones: an attempt to understand the underlying mechanism of actions. Expert Opin Pharmacother 2011;12(17):2673-81
   PubMed Web of Science ®Google Scholar
• Ioannou GN, Van Rooyen DM, Savard C, et al. Cholesterol-lowering drugs cause dissolution of cholesterol crystals and disperse Kupffer cell crown-like structures during resolution of NASH. J Lipid Res 2015;56(2):277-85
   PubMed Web of Science ®Google Scholar
• Piorkowski M, Fischer S, Stellbaum C, et al. Treatment with ezetimibe plus low-dose atorvastatin compared with higher-dose atorvastatin alone: is sufficient cholesterol-lowering enough to inhibit platelets? J Am Coll Cardiol 2007;49(10):1035-42
   PubMed Web of Science ®Google Scholar
• Ben-Yehuda O, Wenger NK, Constance C, et al. The comparative efficacy of ezetimibe added to atorvastatin 10 mg versus uptitration to atorvastatin 40 mg in subgroups of patients aged 65 to 74 years or greater than or equal to 75 years. J Geriatr Cardiol 2011;8(1):1-11
   Web of Science ®Google Scholar
• Zieve F, Wenger NK, Ben-Yehuda O, et al. Safety and efficacy of ezetimibe added to atorvastatin versus up titration of atorvastatin to 40 mg in Patients > or = 65 years of age (from the ZETia in the ELDerly [ZETELD] study). Am J Cardiol 2010;105(5):656-63
   PubMed Web of Science ®Google Scholar
• Ballantyne CM, Houri J, Notarbartolo A, et al. Effect of ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial. Circulation 2003;107(19):2409-15
   PubMed Web of Science ®Google Scholar
• Weng TC, Yang YH, Lin SJ, Tai SH. A systematic review and meta-analysis on the therapeutic equivalence of statins. J Clin Pharm Ther 2010;35(2):139-51
   PubMed Web of Science ®Google Scholar
• Baigent C, Landray MJ, Reith C, et al. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet 2011;377(9784):2181-92
   PubMed Web of Science ®Google Scholar
• Zafra C, Abraldes JG, Turnes J, et al. Simvastatin enhances hepatic nitric oxide production and decreases the hepatic vascular tone in patients with cirrhosis. Gastroenterology 2004;126(3):749-55
   PubMed Web of Science ®Google Scholar
• Abraldes JG, Albillos A, Banares R, et al. Simvastatin lowers portal pressure in patients with cirrhosis and portal hypertension: a randomized controlled trial. Gastroenterology 2009;136(5):1651-8
   PubMed Web of Science ®Google Scholar
• Eshraghian A, Kamyab AA. Rhabdomyolysis developing secondary to atorvastatin therapy in a patient with liver cirrhosis. Intern Med 2013;52(7):823-5
   PubMed Web of Science ®Google Scholar
• Chang CH, Kusama M, Ono S, et al. Assessment of statin-associated muscle toxicity in Japan: a cohort study conducted using claims database and laboratory information. BMJ open 2013;3(4):e002040
   Google Scholar
• Mackay JW, Fenech ME, Myint KS. Acute rhabdomyolysis caused by combination therapy with atorvastatin and warfarin. Br J Hosp Med (Lond) 2012;73(2):106-7
   PubMed Web of Science ®Google Scholar
• Wilinski J, Dabrowski M. Safety and tolerability of the use of atorvastatin 40 mg in common daily practice in short-term observation in 3,227 patients. Przegl Lek 2013;70(6):373-6
   PubMedGoogle Scholar
• Vrablik M, Zlatohlavek L, Stulc T, et al. Statin-associated myopathy: from genetic predisposition to clinical management. Physiol Res 2014;63(Suppl 3):S327-34
   PubMed Web of Science ®Google Scholar
• Boonmuang P, Nathisuwan S, Chaiyakunapruk N, et al. Characterization of Statin-Associated Myopathy Case Reports in Thailand Using the Health Product Vigilance Center Database. Drug Saf 2013. [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• Franco D, Henao Y, Monsalve M, et al. [Hypolipidemic agents drug interactions: approach to establish and assess its clinical significance. Structured review]. Farm Hosp 2013;37(6):539-57
   PubMedGoogle Scholar
• Chauvin B, Drouot S, Barrail-Tran A, Taburet AM. Drug-drug interactions between HMG-CoA reductase inhibitors (statins) and antiviral protease inhibitors. Clin Pharmacokinet 2013;52(10):815-31
   PubMed Web of Science ®Google Scholar
• Patel AM, Shariff S, Bailey DG, et al. Statin toxicity from macrolide antibiotic coprescription: a population-based cohort study. Ann Intern Med 2013;158(12):869-76
   PubMed Web of Science ®Google Scholar
• Cziraky MJ, Willey VJ, McKenney JM, et al. Risk of hospitalized rhabdomyolysis associated with lipid-lowering drugs in a real-world clinical setting. J Clin Lipidol 2013;7(2):102-8
   PubMed Web of Science ®Google Scholar
• Gigante A, Giraldi GD, Gasperini ML, et al. Rhabdomyolysis after midazolam administration in a cirrhotic patient treated with atorvastatin. World J Gastrointest Pharmacol Ther 2014;5(3):196-9
   Google Scholar
• Ara R, Pandor A, Tumur I, et al. Cost effectiveness of ezetimibe in patients with cardiovascular disease and statin intolerance or contraindications: a Markov model. Am J Cardiovasc Drugs 2008;8(6):419-27
   PubMed Web of Science ®Google Scholar
• Pandor A, Ara RM, Tumur I, et al. Ezetimibe monotherapy for cholesterol lowering in 2,722 people: systematic review and meta-analysis of randomized controlled trials. J Intern Med 2009;265(5):568-80
   PubMed Web of Science ®Google Scholar
• Gandhi N, Lenton R, Bhartia M, et al. Effect of fibrate treatment on liver function tests in patients with the metabolic syndrome. SpringerPlus 2014;3:14
   PubMedGoogle Scholar
• Weffald LA, Flach LA. Myopathy associated with atorvastatin-ezetimibe combination therapy. 2007. Available from: http://www.ncbi.nlm.nih.gov/pubmed/17253923
   Google Scholar
• Sattar N, Preiss D, Murray HM, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010;375(9716):735-42
   PubMed Web of Science ®Google Scholar
• Preiss D, Seshasai SR, Welsh P, et al. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. Jama 2011;305(24):2556-64
   PubMed Web of Science ®Google Scholar
• Culver AL, Ockene IS, Balasubramanian R, et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Women’s Health Initiative. Arch Intern Med 2012;172(2):144-52
   PubMed Web of Science ®Google Scholar
• Athyros VG, Mikhailidis DP. Pharmacotherapy: statins and new-onset diabetes mellitus--a matter for debate. Nat Rev Endocrinol 2012;8(3):133-4
   PubMed Web of Science ®Google Scholar
• Athyros VG, Tziomalos K, Karagiannis A, Mikhailidis DP. Lipid-lowering agents and new onset diabetes mellitus. Expert Opin Pharmacother 2010;11(12):1965-70
   PubMed Web of Science ®Google Scholar
• Liptruzet: a combination of ezetimibe and atorvastatin. Med Lett Drugs Ther 2013;55(1419):49-50
   PubMed Web of Science ®Google Scholar