The second United Kingdom Heart and Renal Protection (UK-HARP-II) study: A randomized controlled study of the biochemical safety and efficacy of adding ezetimibe to simvastatin as initial therapy among patients with CKD

American Journal of Kidney Diseases

Volumn 47, Issue 3, 2006, Pages 385-395

  Landray, Martin ^a   Baigent, Colin ^b   Leaper, Craig ^b   Adu, Dwomoa ^b   Altmann, Paul ^b   Armitage, Jane ^b   Ball, Simon ^b   Baxter, Alex ^b   Blackwell, Lisa ^b   Cairns, Hugh S ^b   Carr, Sue ^b   Collins, Rory ^b   Kourellias, Karen ^b   Rogerson, Mary ^b   Scoble, John E ^b   Tomson, Charles R V ^b   Warwick, Graham ^b   Wheeler, David C ^b  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b NONE

Author keywords

Cardiovascular disease; Chronic kidney disease (CKD); Dyslipidemia; Ezetimibe; Randomized controlled trials

Indexed keywords

CREATINE KINASE; EZETIMIBE PLUS SIMVASTATIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; SIMVASTATIN; TRIACYLGLYCEROL;

ABDOMINAL DISCOMFORT; ADULT; AGED; ANOREXIA; ARTICLE; CHRONIC KIDNEY DISEASE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEART PROTECTION; HUMAN; LIVER FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MUSCLE WEAKNESS; MYALGIA; NAUSEA; PERITONEAL DIALYSIS; RANDOMIZED CONTROLLED TRIAL; RENAL PROTECTION;

ANTICHOLESTEREMIC AGENTS; AZETIDINES; CHRONIC DISEASE; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; KIDNEY DISEASES; MALE; MIDDLE AGED; SIMVASTATIN;

EID: 32844473141     PISSN: 02726386     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.ajkd.2005.11.018     Document Type: Article

References (25)

1. Scandinavian Simvastatin Survival Study Group Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease The Scandinavian Simvastatin Survival Study (4S) Lancet 344 1994 1383 1389
2. B.M.Y. Cheung, I.J. Lauder, C.-P. Lau, C.R. Kumana Meta-analysis of large randomized controlled trials to evaluate the impact of statins on cardiovascular outcomes Br J Clin Pharmacol 57 2004 640 652
3. MRC/BHF Heart Protection Study Collaborative Group Randomised placebo-controlled trial of cholesterol-lowering with simvastatin in 20,536 high-risk individuals Lancet 360 2002 7 22
4. R.N. Foley, P.S. Parfrey, M.J. Sarnak Clinical epidemiology of cardiovascular disease in chronic renal disease Am J Kidney Dis 21 suppl 3 1998 S112 S119
5. C. Baigent, K. Burbury, D. Wheeler Premature cardiovascular disease in chronic renal failure Lancet 356 2000 147 152
6. D. Ansell, T. Feest, C. Byrne, A. Ahmad Factors that may influence cardiovascular disease - Blood pressure and serum cholesterol The Renal Association UK Renal Registry Sixth Annual Report 2003 Renal Association Bristol, UK 145 171
7. National Kidney Foundation K/DOQI Clinical Practice Guidelines for Managing Dyslipidemias in Chronic Kidney Disease Am J Kidney Dis 41 suppl 3 2003 S1 S91
8. R.N. Foley, P.S. Parfrey, J.D. Harnett Clinical and echocardiographic disease in patients starting end-stage renal disease therapy Kidney Int 47 1995 186 192
9. C. Baigent, M. Landray, M. Warren Statin therapy in kidney disease populations Potential benefits beyond lipid lowering and the need for clinical trials Curr Opin Nephrol Hypertens 13 2004 601 605
10. C. Baigent, M. Landray, C. Leaper First United Kingdom Heart and Renal Protection study (UK-HARP-I) Biochemical efficacy and safety of simvastatin, and safety of low-dose aspirin, in chronic kidney disease Am J Kidney Dis 45 2005 473 484
11. GISSIGruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico Prevenzione Investigators: Results of the low-dose (20 mg) pravastatin GISSI Prevenzione trial in 4271 patients with recent myocardial infarction: Do stopped trials contribute to overall knowledge? Ital Heart J 1 2000 810 820
12. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT) Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care JAMA 288 2002 2998 3007
13. M.H. Davidson, T. McGarry, R. Bettis Ezetimibe Study Group Ezetimibe coadministered with simvastatin in patients with primary hypercholesterolemia J Am Coll Cardiol 40 2002 2125 2134
14. A.C. Goldberg, A. Sapre, J. Liu, R. Capece, Y.B. Mitchel Ezetimibe Study Group Efficacy and safety of ezetimibe coadministered with simvastatin in patients with primary hypercholesterolemia A randomized, double-blind, placebo-controlled trial Mayo Clin Proc 79 2004 620 629
15. H. Bays, L. Ose, N. Fraser A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia Clin Ther 26 2004 1758 1773
16. L. Melani, R. Mills, D. Hassman Ezetimibe Study Group Efficacy and safety of ezetimibe coadministered with pravastatin in patients with primary hypercholesterolemia A prospective, randomized, double-blind trial Eur Heart J 24 2003 717 728
17. C.M. Ballantyne, J. Houri, A. Notarbartolo Ezetimibe Study Group Effect of ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia. A prospective, randomized, double-blind trial Circulation 107 2003 2409 2415
18. L. Reyderman, T. Kosoglou, P. Statkevich, L. Pember, S. Maxwell, V. Batra Pharmacokinetics of ezetimibe in subjects with normal renal function or severe chronic renal insufficiency Clin Pharmacol Ther 71 2002 MPI89A (abstr)
19. S.J. White, L.S. Freedman Allocation of patients to treatment groups in a controlled clinical study Br J Cancer 37 1978 849 857
20. J.R. McNamara, T.G. Cole, J.H. Contois, C.A. Ferguson, J.M. Ordovas, E.J. Schaefer Immunoseparation method for measuring low-density lipoprotein cholesterol directly from serum evaluated Clin Chem 41 1995 232 240
21. A.S. Levey, J.P. Bosch, J.B. Lewis, T. Greene, N. Rogers, D. Roth Modification of Diet in Renal Disease Study Group A more accurate method to estimate glomerular filtration rate from serum creatinine A new prediction equation Ann Intern Med 120 1999 461 470
22. C. Baigent, M.J. Landray Study of Heart and Renal Protection (SHARP) Kidney Int Suppl 84 2003 S207 S210
23. C.A. Dujovne, M.P. Ettinger, J.F. McNeer Ezetimibe Study Group Efficacy and safety of a potent new selective cholesterol absorption inhibitor, ezetimibe, in patients with primary hypercholesterolemia Am J Cardiol 90 2002 1092 1097
24. R.H. Knopp, H. Gitter, T. Truitt Ezetimibe Study Group Effects of ezetimibe, a new cholesterol absorption inhibitor, on plasma lipids in patients with primary hypercholesterolemia Eur Heart J 24 2003 729 741
25. W.A. Behrens, J.N. Thompson, R. Madère Distribution of α-tocopherol in human plasma lipoproteins Am J Clin Nutr 35 1982 691 696