Safety and efficacy of long-term combination therapy with bezafibrate and ezetimibe in patients with dyslipidemia in the prospective, observational J-COMPATIBLE study

Cardiovascular Diabetology

Volumn 12, Issue 1, 2013, Pages

  Teramoto, Tamio ^a   Abe, Kazunori ^b   Taneyama, Takehiko ^b  

^a TEIKYO UNIVERSITY   (Japan)

^b KISSEI PHARMACEUTICAL CO LTD   (Japan)

Author keywords

Bezafibrate; Combination therapy; Dyslipidemia; Ezetimibe; Gallstone; High density lipoprotein cholesterol; Low density lipoprotein cholesterol; Non high density lipoprotein cholesterol; Triglyceride

Indexed keywords

BEZAFIBRATE; EZETIMIBE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; TRIACYLGLYCEROL; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CREATINE KINASE; CREATININE;

ADULT; AGED; ARTICLE; ASYMPTOMATIC DISEASE; CHOLESTEROL BLOOD LEVEL; CLINICAL EFFECTIVENESS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; CREATININE BLOOD LEVEL; DIABETES MELLITUS; DIASTOLIC BLOOD PRESSURE; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSLIPIDEMIA; FEMALE; GALLSTONE; GASTRIC ULCER BLEEDING; HUMAN; JAPAN; KIDNEY DYSFUNCTION; LIPID ANALYSIS; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYALGIA; OBSERVATIONAL STUDY; PRIMARY PREVENTION; PROSPECTIVE STUDY; RISK ASSESSMENT; SECONDARY PREVENTION; SIDE EFFECT; STOMACH CANCER; SYSTOLIC BLOOD PRESSURE; TRIACYLGLYCEROL BLOOD LEVEL; UREA NITROGEN BLOOD LEVEL; ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; COMBINATION CHEMOTHERAPY; COMORBIDITY; DRUG DOSE SEQUENCE; KIDNEY DISEASE; MIDDLE AGED; STOMACH ULCER; TREATMENT DURATION;

AGED; AZETIDINES; BEZAFIBRATE; BIOLOGICAL MARKERS; CHOLESTEROL, HDL; CHOLESTEROL, LDL; DRUG THERAPY, COMBINATION; DYSLIPIDEMIAS; FEMALE; HUMANS; HYPOLIPIDEMIC AGENTS; JAPAN; LIPIDS; MALE; MIDDLE AGED; PRODUCT SURVEILLANCE, POSTMARKETING; PROSPECTIVE STUDIES; TIME FACTORS; TREATMENT OUTCOME; TRIGLYCERIDES;

EID: 84887041040     PISSN: None     EISSN: 14752840     Source Type: Journal    
DOI: 10.1186/1475-2840-12-163     Document Type: Article

References (34)

1. LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, Wenger NK, Treating to New Targets (TNT) Investigators Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005, 352:1425-1435. 10.1056/NEJMoa050461, 15755765, Treating to New Targets (TNT) Investigators.
2. Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R, CholesterolTreatment Trialists' (CTT) Collaborators Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90056 participants in 14 randomised trials of statins. Lancet 2005, 366:1267-1278. CholesterolTreatment Trialists' (CTT) Collaborators.
3. Rubenfire M, Impact of Medical Subspecialty on Patient Compliance to Treatment Study Group Safety and compliance with once-daily extended-release/lovastatin as initial therapy in the Impact of Medical Subspecialty on Patient Compliance to Treatment (IMPACT) study. Am J Cardiol 2004, 94:306-311. 10.1016/j.amjcard.2004.04.024, 15276093, Impact of Medical Subspecialty on Patient Compliance to Treatment Study Group.
4. Ginsberg HN, Elam MB, Lovato LC, Crouse JR, Leiter LA, Linz P, Friedewald WT, Buse JB, Gerstein HC, Probstfield J, Grimm RH, Ismail-Beigi F, Bigger JT, Goff DC, Cushman WC, Simons-Morton DG, Byington RP, ACCORD Study Group Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010, 362:1563-1574. 2879499, 20228404, ACCORD Study Group.
5. Chapman MJ, Ginsberg HN, Amarenco P, Andreotti F, Borén J, Catapano AL, Descamps OS, Fisher E, Kovanen PT, Kuivenhoven JA, Lesnik P, Masana L, Nordestgaard BG, Ray KK, Reiner Z, Taskinen MR, Tokgözoglu L, Tybjærg-Hansen A, Watts GF. European Atherosclerosis Society Consensus Panel. Triglyceride-rich lipoproteins and high-density lipoprotein cholesterol in patients at high risk of cardiovascular disease: evidence and guidance for management. Eur Heart J 2011, 32:1345-1361. 10.1093/eurheartj/ehr112, 3105250, 21531743.
6. Sone H, Tanaka S, Tanaka S, Iimuro S, Ishibashi S, Oikawa S, Shimano H, Katayama S, Ohashi Y, Akanuma Y, Yamada N, Japan Diabetes Complications Study Group Comparison of various lipid variables as predictors of coronary heart disease in Japanese men and women with type 2 diabetes: subanalysis of the Japan Diabetes Complications Study. Diabetes Care 2012, 35:1150-1157. 10.2337/dc11-1412, 3329821, 22338107, Japan Diabetes Complications Study Group.
7. Turner RC, Millns H, Neil HA, Stratton IM, Manley SE, Matthews DR, Holman RR. Risk factors for coronary artery disease in non-insulin dependent diabetes mellitus: United Kingdom Prospective Diabetes Study (UKPDS 23). BMJ 1998, 316:823-828. 10.1136/bmj.316.7134.823, 28484, 9549452.
8. 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 R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D, European Association for Cardiovascular Prevention & Rehabilitation ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J 2011, 32:1769-1818. European Association for Cardiovascular Prevention & Rehabilitation.
9. Teramoto T, Sasaki J, Ueshima H, Egusa G, Kinoshita M, Shimamoto K, Daida H, Biro S, Hirobe K, Funahashi T, Yokote K, Yokode M. Executive summary of Japan Atherosclerosis Society (JAS) guideline for diagnosis and prevention of atherosclerotic cardiovascular diseases for Japanese. J Atheroscler Thromb 2007, 14:45-50. 10.5551/jat.14.45, 17485887.
10. Tenenbaum A, Fisman EZ. Balanced pan-PPAR activator bezafibrate in combination with statin: comprehensive lipids control and diabetes prevention?. Cardiovasc Diabetol 2012, 11:140. 10.1186/1475-2840-11-140, 3502168, 23150952.
11. Willson TM, Brown PJ, Sternbach DD, Henke BR. The PPARs: from orphan receptors to drug discovery. J Med Chem 2000, 43:527-550. 10.1021/jm990554g, 10691680.
12. Gagné C, Gaudet D, Bruckert E, Ezetimibe Study Group Efficacy and safety of ezetimibe coadministered with atorvastatin or simvastatin in patients with homozygous familial hypercholesterolemia. Circulation 2002, 105:2469-2475. 10.1161/01.CIR.0000018744.58460.62, 12034651, Ezetimibe Study Group.
13. Farnier M, Freeman MW, Macdonell G, Perevozskaya I, Davies MJ, Mitchel YB, Gumbiner B, Ezetimibe Study Group Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidaemia. Eur Heart J 2005, 26:897-905. 10.1093/eurheartj/ehi231, 15781429, Ezetimibe Study Group.
14. McKenney JM, Farnier M, Lo KW, Bays HE, Perevozkaya I, Carlson G, Davies MJ, Mitchel YB, Gumbiner B. Safety and efficacy of long-term co-administration of fenofibrate and ezetimibe in patients with mixed hyperlipidemia. J Am Coll Cardiol 2006, 47:1584-1587. 10.1016/j.jacc.2005.11.072, 16630994.
15. Bays HE, Shah A, Macdonell G, Taggart WV, Gumbiner B. Effects of coadministered ezetimibe plus fenofibrate in mixed dyslipidemic patients with metabolic syndrome. Metab Syndr Relat Disord 2011, 9:135-142. 10.1089/met.2010.0068, 21117970.
16. Kashiwagi A, Kasuga M, Araki E, Oka Y, Hanafusa T, Ito H, Tominaga M, Oikawa S, Noda M, Kawamura T, Sanke T, Namba M, Hashiramoto M, Sasahara T, Nishio Y, Kuwa K, Ueki K, Takei I, Umemoto M, Murakami M, Yamakado M, Yatomi Y, Ohashi H. Committee on the Standardization of Diabetes Mellitus-Related Laboratory Testing of Japan Diabetes Society: International clinical harmonization of glycated hemoglobin in Japan: from Japan Diabetes Society to National Glycohemoglobin Standardization Program values. J Diab Invest 2012, 3:39-40.
17. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 1972, 18:499-502.
18. The BIP Study Group Secondary prevention by raising HDL cholesterol and reducing triglycerides in patients with coronary artery disease: the Bezafibrate Infarction Prevention (BIP) study. Circulation 2000, 102:21-27. The BIP Study Group.
19. Keech A, Simes RJ, Barter P, Best J, Scott R, Taskinen MR, Forder P, Pillai A, Davis T, Glasziou P, Drury P, Kesäniemi YA, Sullivan D, Hunt D, Colman P, d'Emden M, Whiting M, Ehnholm C, Laakso M, FIELD study investigators 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, 366:1849-1861. FIELD study investigators.
20. Teramoto T, Shirai K, Daida H, Yamada N. Effects of bezafibrate on lipid and glucose metabolism in dyslipidemic patients with diabetes: the J-BENEFIT study. Cardiovasc Diabetol 2012, 11:29. 10.1186/1475-2840-11-29, 3342914, 22439599.
21. Amend KL, Landon J, Thyagarajan V, Niemcryk S, McAfee A. Incidence of hospitalized rhabdomyolysis with statin and fibrate use in an insured US population. Ann Pharmacother 2011, 45:1230-1239. 10.1345/aph.1Q110, 21917557.
22. Türk TR, Voropaeva E, Kohnle M, Nürnberger J, Philipp T, Kribben A, Heemann U, Witzke O. Ezetimibe treatment in hypercholesterolemic kidney transplant patients is safe and effective and reduces the decline of renal allograft function: a pilot study. Nephrol Dial Transplant 2008, 23:369-373.
23. Pandor A, Ara RM, Tumur I, Wilkinson AJ, Paisley S, Duenas A, Durrington PN, Chilcott J. Ezetimibe monotherapy for cholesterol lowering in 2,722 people: systematic review and meta-analysis of randomized controlled trials. J Intern Med 2009, 265:568-580. 10.1111/j.1365-2796.2008.02062.x, 19141093.
24. Roglans N, Vázquez-Carrera M, Alegret M, Novell F, Zambón D, Ros E, Laguna JC, Sánchez RM. Fibrates modify the expression of key factors involved in bile-acid synthesis and biliary-lipid secretion in gallstone patients. Eur J Clin Pharmacol 2004, 59:855-861. 10.1007/s00228-003-0704-1, 14685799.
25. Stein A, Hermoni D, Elis A, Konikoff FM. Effect of ezetimibe on the prevalence of cholelithiasis. World J Gastroenterol 2012, 18:5789-5792. 10.3748/wjg.v18.i40.5789, 3484349, 23155321.
26. Shaffer EA. Epidemiology and risk factors for gallstone disease: has the paradigm changed in the 21st century?. Curr Gastroenterol Rep 2005, 7:132-140. 10.1007/s11894-005-0051-8, 15802102.
27. Halldestam I, Kullman E, Borch K. Incidence of and potential risk factors for gallstone disease in a general population sample. Br J Surg 2009, 96:1315-1322. 10.1002/bjs.6687, 19847878.
28. Tung TH, Ho HM, Shih HC, Chou P, Liu JH, Chen VT, Chan DC, Liu CM. A population-based follow-up study on gallstone disease among type 2 diabetics in Kinmen, Taiwan. World J Gastroenterol 2006, 12:4536-4540.
29. Tremblay-Mercier J, Tessier D, Plourde M, Fortier M, Lorrain D, Cunnane SC. Bezafibrate mildly stimulates ketogenesis and fatty acid metabolism in hypertriglyceridemic subjects. J Pharmacol Exp Ther 2010, 334:341-346. 10.1124/jpet.110.166504, 20404010.
30. Yamada K, Tsunoda K, Kawai K, Ikeda T, Taguchi K, Kajita K, Morita H, Ishizuka T. Mitochondria toxicity of antihyperlipidemic agents bezafibrate and fenofibrate. Diabetol Int 2013, 4:126-131.
31. Kitamura A, Noda H, Nakamura M, Kiyama M, Okada T, Imano H, Ohira T, Sato S, Yamagishi K, Iso H. Association between Non-High-Density Lipoprotein Cholesterol Levels and the Incidence of Coronary Heart Disease among Japanese: The Circulatory Risk in Communities Study (CIRCS). J Atheroscler Thromb 2011, 18:454-463. 10.5551/jat.7237, 21378473.
32. Pischon T, Girman CJ, Sacks FM, Rifai N, Stampfer MJ, Rimm EB. Non-high-density lipoprotein cholesterol and apolipoprotein B in the prediction of coronary heart disease in men. Circulation 2005, 112:3375-3383. 10.1161/CIRCULATIONAHA.104.532499, 16316964.
33. Jones PH, Goldberg AC, Knapp HR, Kelly MT, Setze CM, Stolzenbach JC, Sleep DJ. Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia. Am Heart J 2010, 160:759-766. 10.1016/j.ahj.2010.06.045, 20934572.
34. Farnier M, Retterstøl K, Steinmetz A, Császár A. Comparative efficacy and safety of fenofibrate/pravastatin plus ezetimibe triple therapy and simvastatin/ezetimibe dual therapy in type 2 diabetic patients with mixed hyperlipidaemia and cardiovascular disease. Diab Vasc Dis Res 2012, 9:205-215. 10.1177/1479164111430715, 22228773.