Combination rosuvastatin plus fenofibric acid in a cohort of patients 65 years or older with mixed dyslipidemia: Subanalysis of two randomized, controlled studies

Clinical Cardiology

Volumn 33, Issue 10, 2010, Pages 609-619

  Pepine, Carl J ^a   Jacobson, Terry A ^b   Carlson, Dawn M ^c   Kelly, Maureen T ^c   Setze, Carolyn M ^c   Gold, Alex ^d   Stolzenbach, James C ^c   Williams, Laura A ^c  

^a UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^b EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c ABBOTT LABORATORIES   (United States)

^d ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

C REACTIVE PROTEIN; FENOFIBRIC ACID; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; ROSUVASTATIN; TRIACYLGLYCEROL;

ADULT; AGED; ARTICLE; CLINICAL EVALUATION; CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSLIPIDEMIA; FEMALE; HUMAN; LEG PAIN; LIPID ANALYSIS; MAJOR CLINICAL STUDY; MALE; MIXED DYSLIPIDEMIA; MYOSITIS; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; POST HOC ANALYSIS; RANDOMIZED CONTROLLED TRIAL; RHABDOMYOLYSIS; SIDE EFFECT; TREATMENT RESPONSE; TRIACYLGLYCEROL BLOOD LEVEL;

AGED; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; DYSLIPIDEMIAS; FEMALE; FENOFIBRATE; FLUOROBENZENES; FOLLOW-UP STUDIES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPOLIPIDEMIC AGENTS; LIPIDS; MALE; PYRIMIDINES; SULFONAMIDES; TREATMENT OUTCOME;

EID: 78349263826     PISSN: 01609289     EISSN: 19328737     Source Type: Journal    
DOI: 10.1002/clc.20830     Document Type: Article

References (43)

1. US Bureau of the Census, Hobbs FB., Population Profile of the United States: The Elderly Population. Accessed December 31, 2009.
2. American Heart Association. Heart Disease and Stroke Statistics-2008 Update. Dallas, TX: American Heart Association; 2008.
3. 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: 3143-3421.
4. Thorin E, Thorin-Trescases N., Vascular endothelial ageing, heartbeat after heartbeat. Cardiovasc Res 2009; 84: 24-32.
5. Grundy SM., Age as a risk factor: you are as old as your arteries. Am J Cardiol 1999; 83: 1455-1457.
6. Grundy SM, Cleeman JI, Rifkind BM, et al., Cholesterol lowering in the elderly population. Coordinating Committee of the National Cholesterol Education Program. Arch Intern Med 1999; 159: 1670-1678.
7. Wang L, Jerosch-Herold M, Jacobs DR Jr, et al., Coronary risk factors and myocardial perfusion in asymptomatic adults: the Multi-Ethnic Study of Atherosclerosis (MESA). J Am Coll Cardiol 2006; 47: 565-572. (Pubitemid 43170845)
8. Arsenault BJ, Rana JS, Stroes ES, et al., Beyond low-density lipoprotein cholesterol: respective contributions of non-high-density lipoprotein cholesterol levels, triglycerides, and the total cholesterol/high-density lipoprotein cholesterol ratio to coronary heart disease risk in apparently healthy men and women. J Am Coll Cardiol 2010; 55: 35-41.
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. Stanek EJ, Sarawate C, Willey VJ, et al., Risk of cardiovascular events in patients at optimal values for combined lipid parameters. Curr Med Res Opin 2007; 23: 553-563.
11. Manninen V, Tenkanen L, Koskinen P, et al., Joint effects of serum triglyceride and LDL cholesterol and HDL cholesterol concentrations on coronary heart disease risk in the Helsinki Heart Study: implications for treatment. Circulation 1992; 85: 37-45.
12. Cohen JD, Cziraky MJ, Jacobson TA, et al., Changes in the prevalence of abnormal lipid fractions among US adults: results from the National Health and Nutrition Examination Survey II, III and 1999-2006 [abstract 1189]. Circulation 2008; 118: S1081-S1082.
13. 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: 112-119.
14. Alsheikh-Ali AA, Lin JL, Abourjaily P, et al., Extent to which accepted serum lipid goals are achieved in a contemporary general medical population with coronary heart disease risk equivalents. Am J Cardiol 2006; 98: 1231-1233.
15. Aronow WS., Underutilization of lipid-lowering drugs in older persons with prior myocardial infarction and a serum low-density lipoprotein cholesterol > 125 mg/dL. Am J Cardiol 1998; 82: 668-669.
16. Sueta CA, Chowdhury M, Boccuzzi SJ, et al., Analysis of the degree of undertreatment of hyperlipidemia and congestive heart failure secondary to coronary artery disease. Am J Cardiol 1999; 83: 1303-1307.
17. Yan AT, Yan RT, Tan M, et al., Contemporary management of dyslipidemia in high-risk patients: targets still not met. Am J Med 2006; 119: 676-683.
18. Stacy TA, Egger A., Results of retrospective chart review to determine improvement in lipid goal attainment in patients treated by high-volume prescribers of lipid-modifying drugs. J Manag Care Pharm 2006; 12: 745-751.
19. Lemaitre RN, Psaty BM, Heckbert SR, et al., Therapy with hydroxymethylglutaryl coenzyme a reductase inhibitors (statins) and associated risk of incident cardiovascular events in older adults: evidence from the Cardiovascular Health Study. Arch Intern Med 2002; 162: 1395-1400.
20. Miettinen TA, Pyórà K, Olsson AG, et al., Cholesterol-lowering therapy in women and elderly patients with myocardial infarction or angina pectoris: findings from the Scandinavian Simvastatin Survival Study (4S). Circulation 1997; 96: 4211-4218.
21. Shepherd J, Blauw GJ, Murphy MB, et al., Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002; 360: 1623-1630.
22. Williams MA, Fleg JL, Ades PA, et al., Secondary prevention of coronary heart disease in the elderly (with emphasis on patients > or = 75 years of age): an American Heart Association scientific statement from the Council on Clinical Cardiology Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention. Circulation 2002; 105: 1735-1743.
23. Alagona P Jr,. Beyond LDL cholesterol: the role of elevated triglycerides and low HDL cholesterol in residual CVD risk remaining after statin therapy. Am J Manag Care 2009; 15 (3 suppl): S65-S73.
24. Trilipix [package insert]. North Chicago, IL: Abbott.
25. 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: 208-215.
26. 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 5 mg rosuvastatin in patients with atherogenic dyslipidemia [abstract 1021-85]. J Am Coll Cardiol 2009; 53 (suppl A): A208.
27. Jones PH, Bays HE, Davidson MH, et al., Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins. Clin Drug Investig 2008; 28: 625-634.
28. American Heart Association. An Eating Plan for Healthy Americans: Our American Heart Association Diet. Dallas, TX: American Heart Association; 2004. AHA publication 50-1481A.
29. Pasternak RC, Smith SC Jr, Bairey-Merz CN, et al., ACC/AHA/ NHLBI Clinical Advisory on the Use and Safety of Statins. Circulation 2002; 106: 1024-1028.
30. Jones PH., Fenofibric acid plus statin combination therapy for the treatment of mixed dyslipidemia. Clin Lipidol 2009; 4: 699-711.
31. Robinson JG, Wang S, Smith BJ, et al., Meta-analysis of the relationship between non-high-density lipoprotein cholesterol reduction and coronary heart disease risk. J Am Coll Cardiol 2009; 53: 316-322.
32. Libby P, Ridker PM., Inflammation and atherosclerosis: role of C-reactive protein in risk assessment. Am J Med 2004; 116 (suppl 6A): S9-S16.
33. Tracy RP, Lemaitre RN, Psaty BM, et al., Relationship of C-reactive protein to risk of cardiovascular disease in the elderly: results from the Cardiovascular Health Study and the Rural Health Promotion Project. Arterioscler Thromb Vasc Biol 1997; 17: 1121-1127.
34. Shek A, Ferrill MJ., Statin-fibrate combination therapy. Ann Pharmacother 2001; 35: 908-917.
35. Crestor [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP.
36. Narayan KM, Boyle JP, Thompson TJ, et al., Lifetime risk for diabetes mellitus in the United States. JAMA 2003; 290: 1884-1890.
37. Beckett NS, Peters R, Fletcher AE, et al., Treatment of hypertension in patients 80 years of age or older. N Engl J Med 2008; 358: 1887-1898.
38. The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010; 362: 1563-1574.
39. Benner JS, Glynn RJ, Mogun H, et al., Long-term persistence in use of statin therapy in elderly patients. JAMA 2002; 288: 455-461.
40. Jackevicius CA, Mamdani M, Tu JV., Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA 2002; 288: 462-467.
41. Sica DA., Rationale for fixed-dose combinations in the treatment of hypertension: the cycle repeats. Drugs 2002; 62: 443-462.
42. 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.
43. Kipnes MS, Roth EM, Rhyne JM, et al., Year two assessment of fenofibric acid and moderate-dose statin combination: a phase 3, open-label, extension study. Clin Drug Investig 2010; 30: 51-61.