The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial

The Lancet - Tập 377 Số 9784 - Trang 2181-2192 - 2011
Colin Baigent1, Martin Landray1, Christina Reith1, Jonathan Emberson1, David C. Wheeler2, Charles Tomson3, Christoph Wanner4, Vera Krane4, Alan Cass5, Jonathan C. Craig6, Bruce Neal5, Lixin Jiang7, Lai Seong Hooi8, Adeera Levin9, Lawrence Y. Agodoa10, Mike Gaziano11, Bertram L. Kasiske12, Robert Walker13, Ziad A. Massy14, Bo Feldt‐Rasmussen15, Udom Krairittichai16, Vuddidhej Ophascharoensuk17, Bengt Fellström18, Hallvard Holdaas19, Vladimı́r Tesař20, Andrzej Więcek21, Diederick E. Grobbee22, Dick de Zeeuw23, Carola Grönhagen‐Riska24, Tanaji Dasgupta25, David Lewis1, William G. Herrington1, Marion Mafham1, William Majoni26, Karl Wallendszus1, Richard H. Grimm27, Terje Pedersen28, Jonathan A. Tobert29, Jane Armitage1, Alex Baxter1, Christopher Bray1, Yiping Chen1, Zhengming Chen1, Michael Hill1, Carol Knott1, Sarah Parish1, David Simpson1, Peter Sleight30, Allan H. Young1, Rory Collins1
1Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford, UK
2University College London, London, UK
3North Bristol NHS Trust, Bristol, UK
4Department of Medicine 1, Division of Nephrology, University of Wuerzburg, Wuerzburg, Germany
5The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia
6Sydney School of Public Health, Children's Hospital at Westmead, University of Sydney, Sydney, NSW, Australia
7China Oxford Centre for International Health Research, Fuwai Hospital, Beijing, Chinese Academy of Medical Sciences and Peking Union Medical College, China
8Department of Medicine and Haemodialysis Unit, Sultanah Aminah Hospital, Johor Bahru, Malaysia
9University of British Columbia, Vancouver, BC, Canada
10National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA
11Harvard Medical School, VA Boston, Brigham and Women's Hospital, Boston, MA, USA
12University of Minnesota, Minneapolis, MN, USA;
13Dunedin School of Medicine, University of Otago, Otago, New Zealand
14Division of Clinical Pharmacology and Division of Nephrology, Amiens University Hospital, and INSERM ERI-12, University of Picardie Jules Verne, Amiens, France
15Rigshospitalet University of Copenhagen Copenhagen Denmark
16Division of Nephrology, Department of Medicine, Rajavithi Hospital, Bangkok, Thailand
17Renal Division, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
18University Hospital, Uppsala, Sweden
19Renal Section, Department of Organ Transplantation, Oslo University Hospital, Rikshospitalet, Oslo, Norway
20Department of Nephrology, First School of Medicine and General University Hospital, Charles University, Prague, Czech Republic
21Department of Nephrology, Endocrinology and Metabolic Diseases, Medical University of Silesia, Katowice, Poland
22Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands
23Department of Clinical Pharmacology, University Medical Center Groningen, Groningen, Netherlands
24Helsinki University Hospital, Helsinki, Finland
25Oxford Radcliffe Hospitals NHS Trust, Oxford, UK
26Royal Darwin Hospital, Darwin, NT, Australia
27Berman Center for Outcomes and Clinical Research, Hennepin County Medical Center, University of Minnesota, Minneapolis, MN, USA
28University of Oslo and Centre of Preventive Medicine, Oslo University Hospital Ullevål, Oslo, Norway
29Tobert Medical Consulting LLC, Warren, NJ, USA
30Nuffield Department of Clinical Medicine, John Radcliffe Hospital, Oxford, UK

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Tài liệu tham khảo

2010, Association of estimated glomerular filtration rate and albuminuria with all-cause and cardiovascular mortality in general population cohorts: a collaborative meta-analysis, Lancet, 375, 2073, 10.1016/S0140-6736(10)60674-5

Foley, 1998, Clinical epidemiology of cardiovascular disease in chronic renal disease, Am J Kidney Dis, 32, S112, 10.1053/ajkd.1998.v32.pm9820470

2003, K/DOQI clinical practice guidelines for managing dyslipidemias in chronic kidney disease, Am J Kidney Dis, 41, S1

2005, Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90 056 participants in 14 randomised trials of statins, Lancet, 366, 1267, 10.1016/S0140-6736(05)67394-1

2010, Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170 000 participants in 26 randomised trials, Lancet, 376, 1670, 10.1016/S0140-6736(10)61350-5

Tonelli, 2004, Effect of pravastatin on cardiovascular events in people with chronic kidney disease, Circulation, 110, 1557, 10.1161/01.CIR.0000143892.84582.60

2010, Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12 064 survivors of myocardial infarction: a double-blind randomised trial, Lancet, 376, 1658, 10.1016/S0140-6736(10)60310-8

2008, SLCO1B1 variants and statin-induced myopathy—a genomewide study, N Engl J Med, 359, 789, 10.1056/NEJMoa0801936

Kosoglou, 2005, Ezetimibe: a review of its metabolism, pharmacokinetics and drug interactions, Clin Pharmacokinet, 44, 467, 10.2165/00003088-200544050-00002

Baigent, 2005, First United Kingdom Heart and Renal Protection (UK-HARP-I) study: biochemical efficacy and safety of simvastatin and safety of low-dose aspirin in chronic kidney disease, Am J Kidney Dis, 45, 473, 10.1053/j.ajkd.2004.11.015

Landray, 2006, 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, Am J Kidney Dis, 47, 385, 10.1053/j.ajkd.2005.11.018

2010, Study of Heart and Renal Protection (SHARP): Randomized trial to assess the effects of lowering low-density lipoprotein cholesterol among 9,438 patients with chronic kidney disease, Am Heart J, 160, 785, 10.1016/j.ahj.2010.08.012

Lang, 1991, Estimating the effect of the run-in on the power of the Physicians' Health Study, Stat Med, 10, 1585, 10.1002/sim.4780101010

Pocock, 1975, Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial, Biometrics, 31, 103, 10.2307/2529712

Peto, 1976, Design and analysis of randomized clinical trials requiring prolonged observation of each patient. Part 1: introduction and design, Br J Cancer, 34, 585, 10.1038/bjc.1976.220

Peto, 1977, Design and analysis of randomized clinical trials requiring prolonged observation of each patient. Part 2: analysis and examples, Br J Cancer, 35, 1, 10.1038/bjc.1977.1

Levey, 2000, A simplified equation to predict glomerular filtration from serum creatinine, J Am Soc Nephrol, 11, 155A

2002, K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Part 4. Definition and classification of stages of chronic kidney disease, Am J Kidney Dis, 39, S46

Wanner, 2005, Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis, N Engl J Med, 353, 238, 10.1056/NEJMoa043545

Fellström, 2009, Rosuvastatin and cardiovascular events in patients undergoing hemodialysis, N Engl J Med, 360, 1395, 10.1056/NEJMoa0810177

Holdaas, 2003, Effect of fluvastatin on cardiac outcomes in renal transplant recipients: a multicentre, randomised, placebo-controlled trial, Lancet, 361, 2024, 10.1016/S0140-6736(03)13638-0

Davidson, 2002, Ezetimibe coadministered with simvastatin in patients with primary hypercholesterolemia, J Am Coll Cardiol, 40, 2125, 10.1016/S0735-1097(02)02610-4

Rossebø, 2008, Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis, N Engl J Med, 359, 1343, 10.1056/NEJMoa0804602

Peto, 2008, Analyses of cancer data from three ezetimibe trials, N Engl J Med, 359, 1357, 10.1056/NEJMsa0806603

Cannon, 2008, Rationale and design of IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial), Am Heart J, 156, 826, 10.1016/j.ahj.2008.07.023

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