Efficacy and safety of rosuvastatin and fenofibric acid combination therapy versus simvastatin monotherapy in patients with hypercholesterolemia and hypertriglyceridemia: A randomized, double-blind study

American Journal of Cardiovascular Drugs

Volumn 10, Issue 3, 2010, Pages 175-186

  Roth, Eli M ^a   McKenney, James M ^b   Kelly, Maureen T ^c   Setze, Carolyn M ^c   Carlson, Dawn M ^c   Gold, Alex ^d   Stolzenbach, James C ^c   Williams, Laura A ^c   Jones, Peter H ^a  

^a Sterling Research Group   (United States)

^b National Clinical Research Inc   (United States)

^c AstraZeneca LP ^*

^d BAYLOR COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

APOLIPOPROTEIN B; C REACTIVE PROTEIN; FENOFIBRIC ACID; FENOFIBRIC ACID PLUS ROSUVASTATIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; ROSUVASTATIN; SIMVASTATIN; TRIACYLGLYCEROL; TRILIPIX; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; CREATININE BLOOD LEVEL; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; ELECTROCARDIOGRAPHY; FEMALE; FLATULENCE; HEADACHE; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTRIGLYCERIDEMIA; INCIDENCE; KIDNEY FAILURE; LABORATORY TEST; LIVER FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; MYOPATHY; NAUSEA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHABDOMYOLYSIS; SIDE EFFECT; THORAX PAIN; VITAL SIGN; VOMITING;

ADULT; AGED; ANTICHOLESTEREMIC AGENTS; CHOLESTEROL, HDL; CHOLESTEROL, LDL; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; FLUOROBENZENES; HUMANS; HYPERCHOLESTEROLEMIA; HYPERTRIGLYCERIDEMIA; LIVER; MALE; MIDDLE AGED; PROCETOFEN; PYRIMIDINES; SIMVASTATIN; SULFONAMIDES;

EID: 77953264127     PISSN: 11753277     EISSN: 1179187X     Source Type: Journal    
DOI: 10.2165/11533430-000000000-00000     Document Type: Article

References (36)

1. RosamondW, Flegal K, Furie K, et al. Heart disease and stroke statistics: 2008 update. A report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2008 Jan 29; 117 (4): e25-146
2. Stanek EJ, Sarawate C, Willey VJ, et al. Risk of cardiovascular events in patients at optimal values for combined lipid parameters. CurrMed Res Opin 2007; 23 (3): 553-563
3. Assmann G, Schulte H. Relation of high-density lipoprotein cholesterol and triglycerides to incidence of atherosclerotic coronary artery disease (the PROCAM experience). Prospective Cardiovascular Munster study. Am J Cardiol 1992; 70 (7): 733-737
4. Hokanson JE, Austin MA. 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 1996; 3 (2): 213-219
5. Assmann G, Schulte H, Cullen P, et al. Assessing risk of myocardial infarction and stroke: new data from the Prospective Cardiovascular Munster (PROCAM) study. Eur J Clin Invest 2007; 37 (12): 925-932
6. ThirdReport of the NationalCholesterolEducation 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): 3143-3421
7. Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterollowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005; 366 (9493): 1267-1278
8. Grundy SM, Cleeman JI, Merz CN, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 2004; 110 (2): 227-239
9. Fruchart JC, Sacks F, Hermans MP, et al. The Residual Risk Reduction Initiative: a call to action to reduce residual vascular risk in patients with dyslipidemia. Am J Cardiol 2008; 102 (10 Suppl.): 1K-34K
10. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002; 360 (9326): 7-22
11. Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 2004; 350 (15): 1495-1504
12. LaRosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005; 352 (14): 1425-1435
13. Zocor- (simvastatin) product package insert. Whitehouse Station (NJ): Merck & Co., Inc., June 2008
14. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico. Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Lancet 1999; 354 (9177): 447-455
15. Keech A, Simes RJ, Barter P, 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): 1849-1861
16. The Coronary Drug Project Research Group. Clofibrate and niacin in coronary heart disease. JAMA 1975; 231 (4): 360-381
17. Niacin plus statin to prevent vascular events [online]. Available from URL: http://clinicaltrials.gov/ct2/show/NCT00120289?term=NCT00120289%26rank =1. [Accessed 2010 Mar 2]
18. Treatment of HDL to reduce the incidence of vascular events: HPS2-THRIVE [online]. Available from URL: http://www.ichorg/LOB/media/MEDIA482pdf. [Accessed 2010 Mar 2]
19. The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010; 362: 1563-1574
20. Jones PH, Bays HE, Davidson MH, et al. Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins: study design and rationale of a phase III clinical programme. Clin Drug Investig 2008; 28 (10): 625-634
21. Jones PH, Davidson MH, Kashyap ML, et al. Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: a phase 3 study. Atherosclerosis 2009; 204 (1): 208-215
22. Schuster H. Rosuvastatin: a highly effective new 3-hydroxy-3- methylglutaryl coenzyme A reductase inhibitor. Review of clinical trial data at 10-40mg doses in dyslipidemic patients. Cardiology 2003; 99 (3): 126-139
23. Karalis DG, Ross AM, Vacari RM, et al. Comparison of efficacy and safety of atorvastatin and simvastatin in patients with dyslipidemia with and without coronary heart disease. Am J Cardiol 2002; 89 (6): 667-671
24. American Heart Association. An eating plan for healthy Americans: our American Heart Association diet. Dallas (TX): AHA, 2004. Publication no. 1481A
25. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH harmonised tripartite guidelines. Guidelines for good clinical practice E6 [online]. Available from URL: http://wwwichorg/LOB/media/MEDIA482pdf. [Accessed 2010 Apr 3]
26. Grundy SM, Cleeman JI, Daniels SR, et al. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation 2005; 112 (17): 2735-2752
27. Ghandehari H, Kamal-Bahl S, Wong ND. Prevalence and extent of dyslipidemia and recommended lipid levels in US adults with and without cardiovascular comorbidities: the National Health and Nutrition Examination Survey 2003-2004. Am Heart J 2008; 156 (1): 112-119
28. Jones PH, Davidson MH, Stein EA, et al. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* trial). Am J Cardiol 2003; 92 (2): 152-160
29. Brunzell JD, Davidson M, Furberg CD, et al. Lipoprotein management in patients with cardiometabolic risk: consensus conference report from the American Diabetes Association and the American College of Cardiology Foundation. J Am Coll Cardiol 2008; 51 (15): 1512-1524
30. Roth EM, Rosenson RS, Carlson DM, et al. A phase III study evaluating the efficacy and safety of 135 mg fenofibric acid (ABT-335) in combination with 5mg rosuvastatin in patients with atherogenic dyslipidemia [ACC abstract no. 1021-85]. J Am Coll Cardiol 2009; 53 Suppl. A: A208
31. Fazio S, Linton MF. The role of fibrates in managing hyperlipidemia: mechanisms of action and clinical efficacy. CurrAtheroscler Rep 2004; 6 (2): 148-157
32. Elisaf M. Effects of fibrates on serum metabolic parameters. Curr Med Res Opin 2002; 18 (5): 269-276
33. Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol 2006; 97 (8A): 52C-60C
34. Roberts WC. Safety of fenofibrate: US and worldwide experience. Cardiology 1989; 76 (3): 169-179
35. Jones PH, DavidsonMH, Goldberg AC, et al. Efficacy and safety of fenofibric acid in combination with a statin in patients with mixed dyslipidemia: pooled analysis of three phase 3, 12-week randomized, controlled studies. J Clin Lipidol 2009; 3: 125-137
36. Bays HE, Jones PH, Mohiuddin SM, et al. Long-term safety and efficacy of fenofibric acid in combination with statin therapy for the treatment of patients with mixed dyslipidemia. J Clin Lipidol 2008; 2: 426-435