A randomised trial of three counselling strategies for lifestyle changes in patients with hypercholesterolemia treated with ezetimibe on top of statin therapy (TWICE)

Archives of Cardiovascular Diseases

Volumn 101, Issue 11-12, 2008, Pages 723-735

  Steg, Phillppe Gabriel ^a   Verdier, Jean Claude ^b   Carré, François ^c   Darne, Bernadette ^d   Ducardonnet, Alain ^e   Julliene, Gérard ^e   Farnier, Michel ^f   Giral, Phillippe ^g   Haït, Robert ^h  

^a INSERM   (France)

^b Inst C ur Effort Santé   (France)

^c RENNES UNIVERSITY HOSPITAL   (France)

^d Monitoring Force France   (France)

^e Collège National des Cardiologues Français ^*  (France)

^f Le Point Médical   (France)

^g PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^h CENTRE HOSPITALIER INTERCOMMUNAL   (France)

Author keywords

Ezetimibe; Primary hypercholesterolemia

Indexed keywords

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

ADULT; ARTICLE; CARDIOVASCULAR RISK; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIET THERAPY; DIETARY INTAKE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HUMAN; HYPERCHOLESTEROLEMIA; INTERVENTION STUDY; KINESIOTHERAPY; LIFESTYLE MODIFICATION; MAJOR CLINICAL STUDY; MALE; MOTIVATION; MUSCLE CRAMP; MYALGIA; PATIENT COUNSELING; PHYSICAL ACTIVITY; RANDOMIZED CONTROLLED TRIAL; RHABDOMYOLYSIS;

EID: 58049206459     PISSN: 18752136     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.acvd.2008.10.008     Document Type: Article

References (39)

1. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. European guidelines on cardiovascular disease prevention in clinical practice. Eur J Cardiovasc Prev Rehabil 2003;10:S1-10.
2. Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). 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;106:3121-43.
3. Kavanagh T. Exercise in the primary prevention of coronary artery disease. Can J Cardiol 2001;17:155-61.
4. Snetselaar LG. Nutrition intervention: lessons from clinical trials. In: Coulston AM, Rock CL, Monsen ER, editors. Nutrition in the prevention and treatment of disease. New York: Academic Press; 2001. p. 801 [Chapter 7].
5. Heins JM, Delahanty L. Tools and techniques to facilitate eating behaviour change. In: Coulston AM, Rock CL, Monsen ER, editors. Nutrition in the prevention and treatment of disease. New York: Academic Press; 2001. p. 801 [Chapter 8].
6. Curry JC, Kristal AR, Bowen DJ. An application of the stage model of behaviour change to dietary fat reduction. Health Educ Res 1992;7:97-105.
7. Siero FW, Broer J, Bemelmans WJE, Meyboom-de-Jong BM. Impact of group nutrition education and surplus value of Prochaska-based stage-matched information on health-related cognitions and on Mediterranean nutrition behavior. Health Educ Res 2000;15:635-47.
8. Prochaska JO, DiClementi CC. Stages and processes of self-change in smoking: toward an integrative model of change. J Consult Clin Psychol 1983;51:390-5.
9. Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviours. Am Psychol 1992;47:1102-14.
10. Prochaska JO, Velicier WF, Rossi JS, et al. Stages of change and decisional balance for 12 problem behaviors. Health Psychol 1994;13:39-46.
11. Marcus BH, Rakowski W, Rossi JS. Assessing motivational readiness and decision-making analysis for exercise. Health Psychol 1992;11:257-61.
12. Marcus BH, Simkin LR. The stages of exercise behavior. J Sports Med Phys Fitness 1993;33:83-8.
13. Pearson TA, Denke MA, McBride PE, Battisti WP, Brady WE, Palmisano J. A community-based, randomized trial of ezetimibe added to statin therapy to attain NCEPATP III goals for LDL-cholesterol in hypercholesterolemic patients: the Ezetimibe Add-on to Statin Effectiveness (EASE) trial. Mayo Clin Proc 2005;80:587-95.
14. Donner A, Klar N. Design and analysis of cluster randomised trials in health research. London: Arnold; 2000.
15. Moore H, Summerbell CD, Vail A, Greenwood DC, Adamson AJ. The design features and practicalities of conducting a pragmatic cluster randomized trial of obesity management in primary care. Stat Med 2001;20:331-40.
16. Erhardt IR, Gotto A. The Evolution of European guidelines: changing the management of cholesterol levels. Review. Atherosclerosis 2006;185:12-20.
17. Keys A, Menotti A, Karvonen MJ, et al. The diet and 15-year death rate in the Seven Countries Study. Am J Epidemiol 1986;124:903-15.
18. Renaud S, deLorgeril M, Delaye J, et al. Cretan Mediterranean diet for prevention of coronary heart disease. Am J Clin Nutr 1995;61:1360S-7S.
19. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 1972;18:499-502.
20. 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;90:1084-91.
21. Hintze J. NCSS, PASS and GESS. NCSS. Kaysville, Utah. www.ncss.com [consulté le 4 novembre 2008].
22. Parker DR, Evangelou E, Eaton CB. Intraclass correlation coefficients for cluster randomized trials in primary care: the cholesterol education and research trial (CEART). Contemp Clin Trials 2005;26:260-7.
23. Eldridge S, Cryer C, Feder G, Underwood M. Sample size calculations for intervention trials in primary care randomizing by primary care group: an empirical illustration from one proposed intervention trial. Stat Med 2001;20:367-76.
24. Heo M, Leon AC. Comparison of statistical methods for analysis of clustered binary observations. Stat Med 2005;24: 911-23.
25. Singer JD. Using SAS PROC MIXED to fit multilevel models, hierarchical models, and individual growth models. J Educ Behav Stat 1998;24:323-55.
26. Evans BA, Feng Z, Peterson AV. A comparison of generalized linear mixed model procedures with estimating equations for variance and covariance parameter estimation in longitudinal studies and group randomized trials. Stat Med 2001;20:3353-73.
27. Johnson SS, Driskell MM, Johnson JL, et al. Transtheorical model intervention for adherence to lipid-lowering drugs. Dis Manag 2006;9:102-14.
28. Prospective Studies Collaboration. Blood cholesterol and vascular mortality by age, sex, and blood pressure: a meta-analysis of individual data from 61 prospective studies with 55000 vascular deaths. Lancet 2007;370:1829-39.
29. Foley KA, Simpson Jr RJ, Crouse III JR, 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.
30. Gau GT, Wright RS. Pathophysiology, Diagnosis, and Management of Dyslipidemia. Curr Probl Cardiol 2006;31:445-86.
31. Armitage J. The safety of statins in clinical practice. Lancet 2007;370:1781-90.
32. González CA, Rubio-Guerra AF, Pavía A, Redding FJ, Cervantes JL, Zacarías JL, et al. Effectiveness and safety of ezetimibe added to statin therapy in patients with primary dyslipidaemia not achieving the LDL-C treatment goal on statin monotherapy. Clin Drug Invest 2007;27:333-7.
33. Clarke R, Frost C, Collins R, Appleby P, Peto R. Dietary lipids and blood cholesterol: quantitative meta-analysis of metabolic ward studies. BMJ 1997;314:112-7.
34. Vincent-Baudry S, Defoort C, Gerber M, Bernard MC, Verger P, Helal O, et al. The Medi-RIVAGE study: reduction of cardiovascular disease risk factor after a 3-mo intervention with a Mediterranean-type diet or a low-fat-diet. Am J Clin Nutr 2005;82:964-71.
35. Elley CR, Kerse N, Arroll B, Robinson E. Effectiveness of counselling patients on physical activity in general practice: cluster randomised controlled trial. BMJ 2003;326:793-8.
36. Fourth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (Constituted by representatives of nine societies and by invited experts). European guidelines on cardiovascular disease prevention in clinical practice: executive summary. Eur Heart J 2007;28:2375-414.
37. Afssaps. Prise en charge thérapeutique du patient dyslipidémique. Mars 2005. 11 pages. Available at http://agmed.sante.gouv.fr/pdf/5/rbp/dysreco.pdf. Last Access 13 October 2008.
38. Luepker RV. Current status of cholesterol treatment in the community: the Minnesota Heart Survey. Am J Med 1997;102:37-42.
39. Grundy SM, Cleeman JI, Bariey 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;44:720-32.