The utility of observational studies in clinical decision making: Lessons learned from statin trials

Postgraduate Medicine

Volumn 122, Issue 3, 2010, Pages 222-229

  Foody, JoAnne M ^a   Mendys, Phillip M ^b,c   Liu, Larry Z ^c,d   Simpson Jr , Ross J ^b  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^c PFIZER INC   (United States)

^d WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

Hypertension; Observational study; Randomized controlled trials; Statins

Indexed keywords

ATORVASTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PITAVASTATIN; PRAVASTATIN; ROSUVASTATIN; SIMVASTATIN; HEPTANOIC ACID DERIVATIVE; PYRROLE DERIVATIVE;

ACUTE CORONARY SYNDROME; ARTICLE; CARDIOVASCULAR RISK; CHOLESTEROL BLOOD LEVEL; CLINICAL DECISION MAKING; DRUG EFFICACY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; EVIDENCE BASED MEDICINE; HUMAN; HYPERCHOLESTEROLEMIA; ISCHEMIC HEART DISEASE; MYOPATHY; OBSERVATIONAL STUDY; PRACTICE GUIDELINE; PRIMARY PREVENTION; RISK REDUCTION; CARDIOVASCULAR DISEASE; COMPARATIVE EFFECTIVENESS; DECISION MAKING; EPIDEMIOLOGY; HYPERLIPIDEMIA; HYPERTENSION; OBSERVATION;

CARDIOVASCULAR DISEASES; COMPARATIVE EFFECTIVENESS RESEARCH; DECISION MAKING; EPIDEMIOLOGIC STUDIES; EVIDENCE-BASED MEDICINE; HEPTANOIC ACIDS; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERLIPIDEMIAS; HYPERTENSION; OBSERVATION; PYRROLES; SIMVASTATIN;

EID: 77953107582     PISSN: 00325481     EISSN: 19419260     Source Type: Journal    
DOI: 10.3810/pgm.2010.05.2161     Document Type: Article

References (37)

1. Grundy SM, Cleeman JI, Merz CN, et al; Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. J Am Coll Cardiol. 2004;44(3):720-732.
2. Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ. 2004;328(7455):1519.
3. von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007;370(9596):1453-1457.
4. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357(9263):1191-1194.
5. Keys A, Aravanis C, Blackburn HW, et al. Epidemiological studies related to coronary heart disease: characteristics of men aged 40-59 in seven countries. Acta Med Scand Suppl. 1966;460:1-392.
6. Menotti A, Lanti M, Kromhout D, et al. Homogeneity in the relationship of serum cholesterol to coronary deaths across different cultures: 40-year follow-up of the Seven Countries Study. Eur J Cardiovasc Prev Rehabil. 2008;15(6):719-725.
7. Dawber TR, Meadors GF, Moore FE Jr. Epidemiological approaches to heart disease: the Framingham Study. Am J Public Health Nations Health. 1951;41(3):279-281.
8. Ingelsson E, Schaefer EJ, Contois JH, et al. Clinical utility of different lipid measures for prediction of coronary heart disease in men and women. JAMA. 2007;298(7):776-785.
9. 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.
10. Colhoun HM, Betteridge DJ, Durrington PN, et al; CARDS investigators. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet. 2004;364(9435):685-696.
11. Heart Protection Study Collaborative Group. 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.
12. Shepherd J, Cobbe SM, Ford I, et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med. 1995;333(20):1301-1307.
13. Downs JR, Clearfield M, Weis S, et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA. 1998;279(20):1615-1622.
14. Brown WV, Bays HE, Hassman DR, et al. Efficacy and safety of rosuvastatin compared with pravastatin and simvastatin in patients with hypercholesterolemia: a randomized, double-blind, 52-week trial. Am Heart J. 2002;144(6):1036-1043.
15. LaRosa JC, Grundy SM, Waters DD, et al; Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005;352(14):1425-1435.
16. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994;344(8934):1383-1389.
17. Stender S, Schuster H, Barter P, Watkins C, Kallend D. Comparison of rosuvastatin with atorvastatin, simvastatin and pravastatin in achieving cholesterol goals and improving plasma lipids in hypercholesterolaemic patients with or without the metabolic syndrome in the MERCURY I trial. Diabetes Obes Metab. 2005;7(4):430-438.
18. Insull W Jr, Ghali JK, Hassman DR, Y As JW, Gandhi SK, Miller E; SOLAR Study Group. Achieving low-density lipoprotein cholesterol goals in high-risk patients in managed care: comparison of rosuvastatin, atorvastatin, and simvastatin in the SOLAR trial. Mayo Clin Proc. 2007;82(5):543-550.
19. Hounslow N, Budinski D. Pitavastatin is non-inferior to simvastatin and atorvastatin at usual therapeutic doses in primary hypercholesterolemia or combined dyslipidemia and shows sustained efficacy during 52 weeks treatment. Eur Heart J. 2009;30:764.
20. Graham I, Atar D, Borch-Johnsen K, et al; ESC Committee for Practice Guidelines. European guidelines on cardiovascular disease prevention in clinical practice: executive summary. Atherosclerosis. 2007;194(1):1-45.
21. Yokote K, Bujo H, Hanaoka H, et al. Multicenter collaborative randomized parallel group comparative study of pitavastatin and atorvastatin in Japanese hypercholesterolemic patients: collaborative study on hypercholesterolemia drug intervention and their benefits for atherosclerosis prevention (CHIBA study). Atherosclerosis. 2008;201(2):345-352.
22. Lee SH, Chung N, Kwan J, et al. Comparison of the efficacy and tolerability of pitavastatin and atorvastatin: an 8-week, multicenter, randomized, open-label, dose-titration study in Korean patients with hypercholesterolemia. Clin Ther. 2007;29(11):2365-2373.
23. Pedersen TR, Faergeman O, Kastelein JJ, et al. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA. 2005;294(19):2437-2445.
24. Isaacsohn JL, Davidson MH, Hunninghake D, Singer R, McLain R, Black DM. Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE)-rationale and design of atorvastatin versus usual care in hypercholesterolemic patients with coronary artery disease. Am J Cardiol. 2000;86(2):250-252.
25. Koren MJ, Hunninghake DB; ALLIANCE Investigators. Clinical outcomes in managed-care patients with coronary heart disease treated aggressively in lipid-lowering disease management clinics: the ALLIANCE study. J Am Coll Cardiol. 2004;44(9):1772-1779.
26. Foody JM, Joyce AT, Rudolph AE, Liu LZ, Benner JS. Cardiovascular outcomes among patients newly initiating atorvastatin or simvastatin therapy: a large database analysis of managed care plans in the United States. Clin Ther. 2008;30(1):195-205.
27. Jacobson TA, Wertz DA, Hoy T, Kuznik A, Grochulski D, Cziraky M. Comparison of cardiovascular event rates in patients without cardiovascular disease in whom atorvastatin or simvastatin was newly initiated. Mayo Clin Proc. 2008;83(12):1316-1325.
28. Simpson RJ Jr, Signorovitch J, Birnbaum H, et al. Cardiovascular and economic outcomes after initiation of lipid-lowering therapy with atorvastatin vs simvastatin in an employed population. Mayo Clin Proc. 2009;84(12):1065-1072.
29. Dieleman JP, van Wyk JT, van Wijk MA, et al. Differences between statins on clinical endpoints: a population-based cohort study. Curr Med Res Opin. 2005;21(9):1461-1468.
30. Choudhry NK, Levin R, Winkelmayer WC. Statins in elderly patients with acute coronary syndrome: an analysis of dose and class effects in typical practice. Heart. 2007;93(8):945-951.
31. 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.
32. Tannen RL, Weiner MG, Xie D. Use of primary care electronic medical record database in drug efficacy research on cardiovascular outcomes: comparison of database and randomised controlled trial findings. BMJ. 2009;338:b81.
33. Link E, Parish S, Armitage J, et al. SLCO1B1 variants and statininduced myopathy-a genomewide study. N Engl J Med. 2008;359(8):789-799.
34. Hess G, Sanders KN, Hill J, Liu LZ. Therapeutic dose assessment of patient switching from atorvastatin to simvastatin. Am J Manag Care. 2007;13(suppl 3):S80-S85.
35. Butler R, Wainwright J. Cholesterol lowering in patients with CHD and metabolic syndrome. Lancet. 2007;369(9555):27.
36. Phillips B, Roberts C, Rudolph AE, Morant S, Aziz F, O'Regan C. Switching statins: the impact on patient outcomes. B J Cardiol. 2007;14:280-285.
37. Laurie SJ. NICE on lipid modification: NICE's simplified approach to lipids will not work. BMJ. 2008;336(7657):1324.