Reporting of dietary control frameworks in studies on simvastatin efficacy

Clinical Nutrition

Volumn 29, Issue 3, 2010, Pages 352-357

  Somerset, Shawn M ^a  

^a GRIFFITH UNIVERSITY   (Australia)

Author keywords

Clinical trial design; Dietary methodology; RCT; Statins

Indexed keywords

APOLIPOPROTEIN B; ATORVASTATIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; SIMVASTATIN; TRIACYLGLYCEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

ANGINA PECTORIS; ARTICLE; CARDIAC PATIENT; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; DATA ANALYSIS; DIABETIC PATIENT; DIET THERAPY; DRUG EFFICACY; HEART INFARCTION; HIGH RISK PATIENT; HUMAN; HYPERCHOLESTEROLEMIA; ISCHEMIC HEART DISEASE; LIPOPROTEIN BLOOD LEVEL; LOW FAT DIET; MEDLINE; META ANALYSIS; METHODOLOGY; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT COMPLIANCE; PATIENT COUNSELING; POST HOC ANALYSIS; PRESCRIPTION; SYSTEMATIC REVIEW; THERAPY EFFECT; TREATMENT DURATION; CORONARY DISEASE; DIET; FEMALE; MALE; MULTIMODALITY CANCER THERAPY; PUBLISHING; RANDOMIZED CONTROLLED TRIAL (TOPIC); STANDARDS;

COMBINED MODALITY THERAPY; CORONARY DISEASE; DIET; DIET, FAT-RESTRICTED; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; PATIENT COMPLIANCE; PUBLISHING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SIMVASTATIN;

EID: 77953621832     PISSN: 02615614     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.clnu.2009.10.005     Document Type: Article

References (56)

1. Goldstein L.B., Adams R., Alberts M.J., Appel L.J., Brass L.M., Bushnell C.D., et al. Primary prevention of ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council: cosponsored by the Atherosclerotic Peripheral Vascular Disease Interdisciplinary Working Group; Cardiovascular Nursing Council; Clinical Cardiology Council; Nutrition, Physical Activity, and Metabolism Council; and the Quality of Care and Outcomes Research Interdisciplinary Working Group: the American Academy of Neurology affirms the value of this guideline. Stroke 2006, 37:1583-1633.
2. Igel M., Sudhop T., vonBergmann K. Metabolism and drugs interactions of 3-hydroxy-3-methylglutaryl coenzyme A-reductase inhibitors (statins). Eur J Clin Pharmacol 2001, 57:357-364.
3. Lamarche B., Desroches S., Jenkins D.J.A., Kendall C.W.C., Marchie A., Faulkner D., et al. Combined effects of a dietary portfolio of plant sterols, vegetables protein, viscous fibre and almonds on LDL particle size. British Journal Of Nutrition 2004, 92:657-663.
4. Robinson J.G., Smith B., Maheshwari N., Schrott H. Pleiotropic effects of statins: benefit beyond cholesterol reduction? A meta-regression analysis. J Am Coll Cardiol 2005, 46:1855-1862.
5. Mosca L., Appel L.J., Benjamin E.J., Berra K., Chandra-Strobos N., Fabunmi R.P., et al. Evidence-based guidelines for cardiovascular disease prevention in women. American Heart Association scientific statement. Arteriosclerosis, Thrombosis & Vascular Biology 2004, 24:e29-e50.
6. McCrindle B.W., Urbina E.M., Dennison B.A., Jacobson M.S., Steinberger J., Rocchini A.P., et al. Drug therapy of high-risk lipid abnormalities in children and adolescents: a scientific statement from the American Heart Association Atherosclerosis, Hypertension, and Obesity in Youth Committee, Council of Cardiovascular Disease in the Young, with the Council on Cardiovascular Nursing. Circulation 2007, 115:1948-1967.
7. Simons L.A. Additive effect of plant sterol-ester margarine and cerivastatin in lowering low-density lipoprotein cholesterol in primary hypercholesterolemia. Am J Cardiol 2002, 90:737-740.
8. Insull W., McGovern M.E., Schrott H., Thompson P., Crouse J.R., Zieve F., et al. Efficacy of extended-release niacin with lovastatin for hypercholesterolemia: assessing all reasonable doses with innovative surface graph analysis. Arch Intern Med 2004, 164:1121-1127.
9. Davidson M.H., Stein E.A., Bays H.E., Maki K.C., Doyle R.T., Shalwitz R.A., et al. Efficacy and tolerability of adding prescription omega-3 fatty acids 4 g/d to simvastatin 40 mg/d in hypertriglyceridemic patients: an 8-week, randomized, double-blind, placebo-controlled study. Clin Ther 2007, 29:1354-1367.
10. Kantola T., Kivisto K.T., Neuvonen P.J. Grapefruit juice greatly increases serum concentrations of lovastatin and lovastatin acid. Clin Pharmacol Ther 1998, 63:397-402.
11. Dahan A., Altman H. Food-drug interaction: grapefruit juice augments drug bioavailability-mechanism, extent and relevance. Eur J Clin Nutr 2004, 58:1-9.
12. Paine M.F., Widmer W.W., Hart H.L., Pusek S.N., Beavers K.L., Criss A.B., et al. A furanocoumarin-free grapefruit juice establishes furanocoumarins as the mediators of the grapefruit juice-felodipine interaction. Am J Clin Nutr 2006, 83:1097-1105.
13. De Castro W.V., Mertens-Talcott S., Rubner A., Butterweck V., Derendorf H. Variation of flavonoids and furanocoumarins in grapefruit juices: a potential source of variability in grapefruit juice-drug interaction studies. J Agric Food Chem 2006, 54:249-255.
14. Moon Y.J., Wang X., Morris M.E. Dietary flavonoids: Effects on xenobiotic and carcinogen metabolism. Toxicology in vitro 2006, 20:187-210.
15. Johannot L., Somerset S. Age-related variations in flavonoid intake and sources in the Australian population. Public Health Nutrition 2006, 9:1045-1054.
16. Kamphuis C.B., Giskes K., de Bruijn G.J., Wendel-Vos W., Brug J., van Lenthe F.J. Environmental determinants of fruit and vegetable consumption among adults: a systematic review. Br J Nutr 2006, 96:620-635.
17. Schmitz G., Drobnik W. Pharmacogenomics and pharmacogenetics of cholesterol-lowering therapy. Clin Chem Lab Med 2003, 41:581-589.
18. Kane G.C., Lipsky J.J. Drugs-Grapefruit Juice interactions. Mayo Clinic Proceedings 2000, 75:933-942.
19. Gotto A.M. Review of primary and secondary prevention trials with lovastatin, pravastatin, and simvastatin. Am J Cardiol 2005, 96:34F-38F.
20. Zhou S., Gao Y., Jiang W., Huang M., Xu A., Paxton J.W. Interactions of Herbs with Cytochrome P450. Drugs metabolism reviews 2003, 35:35-98.
21. Kjekshus J., Pedersen T.R. Reducing the risk of coronary events: evidence from the Scandinavian Simvastatin Survival Study (4S). Am J Cardiol 1995, 76:64-68.
22. Collins R., Armitage J., Parish S., Sleigh P., Peto R., Heart Protection Study Collaborative G. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet 2003, 361:2005-2016.
23. Pedersen T.R., Kjekshus J., Berg K., Haghfelt T., Faergeman O., Faergeman G., et al. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Am J Cardiol 1994, 81-87. 2004 Oct.
24. Pyorala K., Ballantyne C.M., Gumbiner B., Lee M.W., Shah A., Davies M.J., et al. Reduction of cardiovascular events by simvastatin in nondiabetic coronary heart disease patients with and without the metabolic syndrome: subgroup analyses of the Scandinavian Simvastatin Survival Study (4S). Diabetes Care 2004, 27:1735-1740.
25. Pyorala K., Pedersen T.R., Kjekshus J., Faergeman O., Olsson A.G., Thorgeirsson G. Cholesterol lowering with simvastatin improves prognosis of diabetic patients with coronary heart disease. A subgroup analysis of the Scandinavian Simvastatin Survival Study (4S). Diabetes Care 1997, 20:614-620.
26. Laaksonen R., Jokelainen K., Laakso J., Sahi T., et al. The effect of simvastatin treatment on natural antioxidants in low-density lipoproteins and high-energy phosphates and ubiquinine in skeletal muscle. Am J Cardiol 1996, 77:851-854.
27. Marz W., Wollschage H., Klein G., Neib A., Wehling M. Safety of low-density lipoprotein cholesterol reduction with atorvastatin versus simvastatin in a coronary heart disease population. Am J Cardiol 1999, 84:7-13.
28. Mihaylova B., Briggs A., Armitage J., Parish S., Gray A., Collins R. Cost-effectiveness of simvastatin in people at different levels of vascular disease risk: economic analysis of a randomised trial in 20,536 individuals. Lancet 2005, 365:1779-1785.
29. Muldoon M.F., Ryan C.M., Sereika S.M., et al. Randomised trial of the effects of simvastain on cognitive functioning in hypercholesterolemic adults. Am J Med 2004, 117:823-829.
30. MAAS Investigators Effects on simvastatin on coronary atheroma: The Multicenter Anti-Atheroma Study (MAAS). The Lancet 1994, 344:633-638.
31. Pedersen T.R., Wilhelmsen L., Faergeman O., Strandberg T.E., Thorgeirsson G., Troedsson L., et al. Follow-up study of patients randomized in the Scandinavian simvastatin survival study (4S) of cholesterol lowering. Am J Cardiol 2000, 86:257-262. 2000 Aug 1.
32. Strandberg T.E., Pyorala K., Cook T.J., Wilhelmsen L., Faergeman O., Thorgeirsson G., et al. Mortality and incidence of cancer during 10-year follow-up of the Scandinavian Simvastatin Survival Study (4S). Lancet 2004, 364:771-777.
33. Wilhelmsen L., Pyorala K., Wedel H., Cook T., Pedersen T., Kjekshus J. Risk factors for a major coronary event after myocardial infarction in the Scandinavian Simvastatin Survival Study (4S). Impact of predicted risk on the benefit of cholesterol-lowering treatment. Eur Heart J 2001, 22:1119-1127.
34. The Scandinavian Simvastatin Survival Study Group Cholesterol-lowering therapy in women and elderly patients with myocardial infarction or angina pectoris. Circulation 1997, 96:4211-4218.
35. Dumont J.M. Effect of cholesterol reduction by simvastatin on progression of coronary atherosclerosis: Design, baseline characteristics, and progress of the Multicenter Anti-Atheroma Study (MAAS). Control Clin Trials 1993, 14:209-228.
36. Gentile S., Turco S., Guarino G., Sasso C.F., Amodio M., Magliano P., et al. Comparative efficacy study of atorvastatin vs simvastatin, pravastatin, lovastatin and placebo in type 2 diabetic patients with hypercholesterolaemia. Diabetes Obes Metab 2000, 2:355-362.
37. Dart A., Jerums G., Nicholson G., d'Emden M., Hamilton-Craig I., Tallis G., et al. A multicenter, double-blind, one year study comparing safety and efficacy of atorvastatin versus simvastatin in patients with hypercholesterolemia. Am J Cardiol 1997, 80:39-44.
38. Rios L.P., Odueyungbo A., Moitri M.O., Rahman M.O., Thabane L.C. Quality of reporting of randomized controlled trials in general endocrinology literature. J Clin Endo Metab 2008, 93:3810-3816.
39. Mullner M., Matthews H., Altman D.G. Reporting on statistical methods to adjust for confounding: a cross-sectional survey. Ann Intern Med 2002, 136:122-126.
40. Strategies for the prevention of coronary heart disease: a policy statement of the European Atherosclerosis Society. Eur Heart J 1987, 8:77-88.
41. Berglund L., Lefevre M., Ginsberg H.N., Kris-Etherton P.M., Elmer P.J., Stewart P.W., et al. Comparison of monounsaturated fat with carbohydrates as a replacement for saturated fat in subjects with a high metabolic risk profile: studies in the fasting and postprandial states. Am J Clin Nutr 2007, 86:1611-1620.
42. Williamson G., Manach C. Bioavailability and bioefficacy of polyphenols in humans. II. Review of 93 intervention studies. Am J Clin Nutr 2005, 81:243S-255S.
43. Manach C., Williamson G., Morand C., Scalbert A., Remesy C. Bioavailability and bioefficacy of polyphenols in humans. I. Review of 97 bioavailability studies. Am J Clin Nutr 2005, 81:230S-242S.
44. Jenkins D.J., Kendall C.W., Marchie A., Faulkner D.A., Wong J.M., de Souza R., et al. Direct comparison of a dietary portfolio of cholesterol-lowering foods with a statin in hypercholesterolemic participants. Am J Clin Nutr 2005, 81:380-387.
45. King A.C., Marcus B., Ahn D., Dunn A.L., Rejeski W.J., Sallis J.F., et al. Identifying subgroups that succeed or fail with three levels of physical activity intervention: the Activity Counseling Trial. Health Psychol 2006, 25:336-347.
46. Freeman S.R., Drake A.L., Heilig L.F., Graber M., McNealy K., Schilling L.M., et al. Statins, fibrates, and melanoma risk: a systematic review and meta-analysis. JNCI 2006, 98:1538-1546. [Review] [69 refs].
47. Sacks F.M. Adherence to statin therapy: why aren't we doing better?. Am J Med 2002, 113:685-686.
48. Mann D.M., Allegrante J.P., Natarajan S., Halm E.A., Charlson M. Predictors of adherence to statins for primary prevention. Cardiovasc Drugs Ther 2007, 21:311-316.
49. Jackevicius C.A., Mamdani M., Tu J.V. Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA 2002, 288:462-467.
50. Paine M.F., Khalighi M., Fisher J.M., Shen D.D., Kunze K.L., Marsh C.L., et al. Characterization of interintestinal and intraintestinal variations in human CYP3A-dependent metabolism. J Pharmacol Exp Ther 1997, 283:1552-1562.
51. Scott L.M., Durant P., Leone-Kabler S., Wood C.E., Register T.C., Townsend A., et al. Effects of prior oral contraceptive use and soy isoflavonoids on estrogen-metabolizing cytochrome P450 enzymes. J Steroid Biochem Mol Biol 2008, 112:179-185.
52. Monroe K.R., Murphy S.P., Kolonel L.N., Pike M.C.C.I.N.B.J.C.J., Pmid Prospective study of grapefruit intake and risk of breast cancer in postmenopausal women: the Multiethnic Cohort Study. Br J Cancer 2007, 97:440-445.
53. Spencer E.A., Key T.J., Appleby P.N., van Gils C.H., Olsen A., Tjonneland A., et al. Prospective study of the association between grapefruit intake and risk of breast cancer in the European Prospective Investigation into Cancer and Nutrition (EPIC). Cancer Causes & Control 2009, 20:803-809.
54. Blanck H.M., Khan L.K., Serdula M.K. Diet and physical activity behavior among users of prescription weight loss medications. Int J Behav Nutr Phys Act 2004, 1:17.
55. Shepherd J., Betteridge D.J., Durrington P., Laker M., Lewis B., Mann J., et al. Strategies for reducing coronary heart disease and desirable limits for blood lipid concentrations: guidelines of the British Hyperlipidaemia Association. Br Med J (Clin Res Ed) 1987, 295:1245-1246.
56. Vale M.J., Jelinek M.V., Best J.D., Dart A.M., Grigg L.E., Hare D.L., et al. Coaching patients On Achieving Cardiovascular Health (COACH): a multicenter randomized trial in patients with coronary heart disease. Arch Intern Med 2003, 163:2775-2783.