Differences between clinical trial efficacy and real-world effectiveness

American Journal of Managed Care

Volumn 12, Issue SUPPL. 15, 2006, Pages

  Davidson, Michael H ^a  

^a RUSH UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATORVASTATIN; CHOLESTEROL; EZETIMIBE PLUS SIMVASTATIN; FLUINDOSTATIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MEVINOLIN; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN; TRIACYLGLYCEROL;

ARTICLE; CHOLESTEROL BLOOD LEVEL; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG COST; DRUG EFFICACY; EDUCATION PROGRAM; FOLLOW UP; HUMAN; HYPERCHOLESTEROLEMIA; HYPERLIPIDEMIA; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MOTIVATION; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PRACTICE GUIDELINE; PRIMARY PREVENTION; PRIORITY JOURNAL; SECONDARY PREVENTION;

ANTILIPEMIC AGENTS; CLINICAL TRIALS; CORONARY DISEASE; HUMANS; HYPERLIPIDEMIAS; TREATMENT OUTCOME; UNITED STATES;

EID: 33845243566     PISSN: 10880224     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (29)

1. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of the 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). JAMA. 2001;285:2486-2497.
2. Baessler A, Fischer M, Huf V, et al. Failure to achieve recommended LDL cholesterol levels by suboptimal statin therapy relates to elevated cardiac event rates. Int J Cardiol. 2005;101:293-298.
3. Cannon CP, Braunwald E, McCabe CH, et al, for the Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004;350:1495-1504.
4. LaRosa JC, Grundy SM, Waters DD, et al, for the 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.
5. Grundy SM, Cleeman JI, Bairey Merz CN, et al, for the Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110:227-239.
6. Fox KM, Gandhi SK, Ohsfeldt RL, et al. Comparing effectiveness of rosuvastatin with other statins in reducing low density lipoprotein cholesterol (LDL-C) in the elderly patient population: results from routine clinical practice setting [abstract]. Circulation. 2006;113:788-834. Abstract No. P89.
7. Willey VJ, Kamat SA, Cziraky MJ, et al. Lipid levels in patients newly initiated on rosuvastatin or atorvastatin in a naturalistic setting [poster]. Presenter at: Academy of Managed Care Pharmacy 17th Annual Meeting & Showcase; April 20-23, 2005; Denver, Colo.
8. Kamat SA, Bullano MF, Gandhi S, et al. Effectiveness of rosuvastatin compared with atorvastatin on NCEP ATP-III LDL-C goal attainment outside of controlled study settings [abstract]. Circulation. 2006;113:788-834. Abstract No. P166.
9. Kamat SA, Gandhi SK, Davidson MH. Comparative effectiveness of rosuvastatin in patients with an increased risk of failure to reach NCEP ATP III goal while receiving other statin therapies [abstract]. Circulation. 2006;113:788-834. Abstract No. P111.
10. Pearson TA, Laurora I, Chu H, Kafonek S. The Lipid Treatment Assessment Project (L-TAP): a multicenter survey to evaluate the percentages of dyslipidemic patients receiving lipid-lowering therapy and achieving low-density lipoprotein cholesterol goals. Arch Intern Med. 2000;160:459-467.
11. Davidson MH, Maki KC, Pearson TA, et al. Results of the National Cholesterol Education Program (NCEP) Evaluation Project Utilizing Novel E-Technology (NEPTUNE) II Survey and Implications for Treatment Under the Recent NCEP Writing Group Recommendations. Am J Cardiol. 2005;96:556-563.
12. Frolkis JP, Pearce GL, Nambi V, Minor S, Sprecher DL. Statins do not meet expectations for lowering low-density lipoprotein cholesterol levels when used in clinical practice. Am J Med. 2002;113:625-629.
13. Mosca L, Merz NB, Blumenthal RS, et al. Opportunity for intervention to achieve American Heart Association guidelines for optimal lipid levels in high-risk women in a managed care setting. Circulation. 2005;111:488-493.
14. Foley KA, Simpson RJ Jr, Crouse JR 3rd, Weiss TW, Markson LE, Alexander CM. Effectiveness of statin titration on low-density lipoprotein cholesterol goal attainment in patients at high risk of atherogenic events. Am J Cardiol. 2003;92:79-81.
15. Paoletti R, Fahmy M, Mahla G, Mizan J, Southworth H. Rosuvastatin demonstrates greater reduction of low-density lipoprotein cholesterol compared with pravastatin and simvastatin in hypercholesterolaemic patients: a randomized, double-blind study. J Cardiovasc Risk. 2001;8:383-390.
16. Davidson M, Ma P, Stein EA, 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. 2002;89:268-275.
17. Olsson AG, Istad H, Luurila O, et al, on behalf of the Rosuvastatin Investigators Group. Effects of rosuvastatin and atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia. Am Heart J. 2002;144:1044-1051.
18. Jones PH, Davidson MH, Stein EA, et al, for the STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR Trial). Am J Cardiol. 2003;92:152-160.
19. Ballantyne CM. Rationale for targeting multiple lipid pathways for optimal cardiovascular risk reduction. Am J Cardiol. 2005;96(9A):14K-19K; discussion 34K-35K.
20. Vasudevan AR, Jones PH. Effective use of combination lipid therapy. Curr Cardiol Rep. 2005;7:471-479.
21. Catapano AL, Davidson MH, Ballantyne CM, et al. Lipid-altering efficacy of ezetimibe/simvastatin single tablet versus rosuvastatin in hypercholesterolemic patients. Curr Med Res Opin. 2006;22:2041-2053.
22. Gagné C, Bays HE, Weiss SR, et al; Ezetimibe Study Group. Efficacy and safety of ezetimibe added to ongoing statin therapy for treatment of patients with primary hypercholesterolemia. Am J Cardiol. 2002;90:1084-1091.
23. Barrios V, Amabile N, Paganelli F, et al. Lipid-altering efficacy of switching from atorvastatin 10mg/day to ezetimibe/simvastatin 10/20mg/day compared to doubling the dose of atorvastatin in hypercholesterolaemic patients with atherosclerosis or coronary heart disease. Int J Clin Pract. 2005;59:1377-1386.
24. Pearson T, Denke M, McBride P, et al. Effectiveness of the addition of ezetimibe to ongoing statin therapy in modifying lipid profiles and attaining low-density lipoprotein cholesterol goals in older and elderly patients: subanalyses of data from a randomized, double-blind, placebo-controlled trial. Am J Geriatr Pharmacother. 2005;3:218-228.
25. Ballantyne CME, Sosef F, Duffield E, et al. Rosuvastatin plus ezetimibe for achievement of low-density lipoprotein cholesterol and C-reactive protein goals: results from the EXPLORER study [poster]. Presented at: World Congress of Cardiology 2006; September 6, 2006; Barcelona, Spain. Poster No. 5390.
26. Valuck RJ, Williams SA, MacArthur M, et al. A retrospective cohort study of correlates of response to pharmacologic therapy for hyperlipidemia in members of a managed care organization. Clin Ther. 2003;25:2936-2957.
27. Büllano MF, Wertz DA, Yang GW, et al. Effect of rosuvastatin compared with other statins on lipid levels and National Cholesterol Education Program goal attainment for low-density lipoprotein cholesterol in a usual care setting. Pharmacotherapy. 2006;26:469-478.
28. Schuster H, Barter PJ, Stender S, et al, for the MERCURY I Study Group. Effects of switching statins on achievement of lipid goals: Measuring Effective Reductions in Cholesterol Using Rosuvastatin Therapy (MERCURY I) study. Am Heart J. 2004;147:705-712.
29. Ballantyne CM, Bertolami M, Hernandez Garcia HR, et al. Achieving LDL cholesterol, non-HDL cholesterol, and apolipoprotein B target levels in high-risk patients: Measuring Effective Reductions in Cholesterol Using Rosuvastatin Therapy (MERCURY II). Am Heart J. 2006;151:975.e1-e9 [epub].