Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: A phase 3 study

Atherosclerosis

Volumn 204, Issue 1, 2009, Pages 208-215

  Jones, Peter H ^a   Davidson, Michael H ^b   Kashyap, Moti L ^c,d   Kelly, Maureen T ^e   Buttler, Susan M ^e   Setze, Carolyn M ^e   Sleep, Darryl J ^e   Stolzenbach, James C ^e  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF CHICAGO   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d VA LONG BEACH HEALTHCARE SYSTEM   (United States)

^e ABBOTT LABORATORIES   (United States)

Author keywords

Cholesterol; Dyslipidemia; Fenofibric acid; Fibrates; Hydroxymethylglutaryl CoA reductase inhibitors; Rosuvastatin

Indexed keywords

FENOFIBRATE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; ROSUVASTATIN; TRIACYLGLYCEROL;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; CREATININE BLOOD LEVEL; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; FEMALE; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MIXED DYSLIPIDEMIA; MONOTHERAPY; MULTICENTER STUDY; MYALGIA; NAUSEA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHABDOMYOLYSIS; SIDE EFFECT; TREATMENT DURATION; TREATMENT OUTCOME;

ADULT; AGED; ANTICHOLESTEREMIC AGENTS; BIOLOGICAL MARKERS; CANADA; CHOLESTEROL, HDL; CHOLESTEROL, LDL; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; DYSLIPIDEMIAS; FEMALE; FLUOROBENZENES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MIDDLE AGED; PROCETOFEN; PUERTO RICO; PYRIMIDINES; SULFONAMIDES; TREATMENT OUTCOME; TRIGLYCERIDES; UNITED STATES;

EID: 67349119255     PISSN: 00219150     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.atherosclerosis.2008.09.027     Document Type: Article

References (21)

1. 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: 3143-421.
2. Stanek E.J., Sarawate C., Willey V.J., Charland S.L., and Cziraky M.J. Risk of cardiovascular events in patients at optimal values for combined lipid parameters. Curr Med Res Opin 23 (2007) 553-563
3. Assmann G., Schulte H., von Eckardstein A., and Huang Y. High-density lipoprotein cholesterol as a predictor of coronary heart disease risk. The PROCAM experience and pathophysiological implications for reverse cholesterol transport. Atherosclerosis 124 Suppl. (1996) S11-S20
4. Hokanson J.E., and Austin M.A. Plasma triglyceride level is a risk factor for cardiovascular disease independent of high-density lipoprotein cholesterol level: a meta-analysis of population-based prospective studies. J Cardiovasc Risk 3 (1996) 213-219
5. Sarwar N., Danesh J., Eiriksdottir G., et al. Triglycerides and the risk of coronary heart disease: 10,158 incident cases among 262,525 participants in 29 Western prospective studies. Circulation 115 (2007) 450-458
6. Sharrett A.R., Ballantyne C.M., Coady S.A., et al. Coronary heart disease prediction from lipoprotein cholesterol levels, triglycerides, lipoprotein(a), apolipoproteins A-I and B, and HDL density subfractions: The Atherosclerosis Risk in Communities (ARIC) Study. Circulation 104 (2001) 1108-1113
7. Athyros V.G., Papageorgiou A.A., Athyrou V.V., Demitriadis D.S., and Kontopoulos A.G. Atorvastatin and micronized fenofibrate alone and in combination in type 2 diabetes with combined hyperlipidemia. Diabetes Care 25 (2002) 1198-1202
8. Durrington P.N., Tuomilehto J., Hamann A., Kallend D., and Smith K. Rosuvastatin and fenofibrate alone and in combination in type 2 diabetes patients with combined hyperlipidaemia. Diabetes Res Clin Pract 64 (2004) 137-151
9. Grundy S.M., Vega G.L., Yuan Z., et al. Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (the SAFARI trial). Am J Cardiol 95 (2005) 462-468
10. Koh K.K., Quon M.J., Han S.H., et al. Additive beneficial effects of fenofibrate combined with atorvastatin in the treatment of combined hyperlipidemia. J Am Coll Cardiol 45 (2005) 1649-1653
11. Buse J.B., Bigger J.T., Byington R.P., et al. Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. Am J Cardiol 99 (2007) 21i-33i
12. Davidson M.H. Statin/fibrate combination in patients with metabolic syndrome or diabetes: evaluating the risks of pharmacokinetic drug interactions. Expert Opin Drug Saf 5 (2006) 145-156
13. Jones P.H., Bays H.E., Davidson M.H., et al. Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins. Clin Drug Invest 28 (2008) 625-634
14. American Heart Association. An eating plan for healthy Americans-our American Heart Association Diet. AHA Publication No. 50-1481A. 2004.
15. Standards of medical care in diabetes-2007. Diabetes Care 30 Suppl. 1 (2007) S4-S41
16. Genest J., Frohlich J., Fodor G., and McPherson R. Recommendations for the management of dyslipidemia and the prevention of cardiovascular disease: summary of the 2003 update. Can Med Assoc J 169 (2003) 921-924
17. Vega G.L., Ma P.T., Cater N.B., et al. Effects of adding fenofibrate (200 mg/day) to simvastatin (10 mg/day) in patients with combined hyperlipidemia and metabolic syndrome. Am J Cardiol 91 (2003) 956-960
18. Davidson M., Ma P., Stein E.A., et al. Comparison of effects on low-density lipoprotein cholesterol and high-density lipoprotein cholesterol with rosuvastatin versus atorvastatin in patients with type IIa or IIb hypercholesterolemia. Am J Cardiol 89 (2002) 268-275
19. Jones P.H., Davidson M.H., Stein E.A., et al. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial). Am J Cardiol 92 (2003) 152-160
20. Barter P.J., and Rye K.A. Is there a role for fibrates in the management of dyslipidemia in the metabolic syndrome?. Arterioscler Thromb Vasc Biol 28 (2008) 39-46
21. Keech A., Simes R.J., Barter P., et al., The 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 366 (2005) 1849-1861