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The Cox proportional-hazards model was used to estimate the multivariate relative risks of the primary and secondary end points with corresponding 95 percent confidence intervals. Death from cardiac causes comprised fatal myocardial infarction (death within 28 days after a myocardial infarction), sudden death, death due to congestive heart failure, death due to coronary heart disease during or within 28 days after an intervention, and all other deaths ascribed to coronary heart disease. (2012) Geographic Variation in HMG-CoA Reductase Inhibitor Use in Dialysis Patients. (2012) Serum non-high-density lipoprotein cholesterol (non-HDL-C) levels and cardiovascular mortality in chronic hemodialysis patients. 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(2014) KDIGO Clinical Practice Guideline for Lipid Management in CKD: summary of recommendation statements and clinical approach to the patient. We conclude that in persons with type 2 diabetes mellitus who are receiving maintenance hemodialysis and have LDL cholesterol values between 80 and 190 mg per deciliter, routine treatment with a statin to reduce the primary composite end point of death from cardiac causes, myocardial infarction, and stroke is not warranted. Antlanger, J. CrossRef 40 Shubha Ananthakrishnan, George A. Furberg, Allan Sniderman. Martin, Gregory A. Current Opinion in Nephrology and Hypertension 22, 259-265. The Korean Journal of Internal Medicine 30, 177. Barrett. J. Brady, A. Kohagura, S. (2015) Dialysate and Serum Potassium in Hemodialysis. Tomaschitz, S. CrossRef 234 Kunitoshi Iseki. (2015) Baseline diabetes as a way to predict CV outcomes in a lipid-modifying trial: a meta-analysis of 330,376 patients from 47 landmark studies. HMG CoA reductase inhibitors (statins) for dialysis patients. Linton, Sergio Fazio, Valentina Kon. Kopecky, S. Jardine. Levin, Philip K. Jardine. Details of the study design have been described previously. Reilly. Tagawa, T. L. (2012) Apolipoprotein A-IV concentrations and clinical outcomes in haemodialysis patients with type 2 diabetes mellitus - a. Locatelli, M. Secondary end points included death from all causes, all cardiac events combined, and all cerebrovascular events combined. CrossRef 210 A. Michael Lincoff, Eric D. Journal of the American Academy of Physician Assistants 27, 17-22. Goldsmith. The protocol was approved by the ethics committee at the coordinating center and the 29 regional institutional review boards. Takishita, S. Free Full Text 360 Christoph Wanner. Podracka, T. H. Current Opinion in Nephrology and Hypertension 22, 651-655. Kyan, S. Yang, N. (2015) Changes over the last decade in carotid atherosclerosis in patients with end-stage kidney disease. The mean length of follow-up was 3. For the study to have this level of power, at least 424 primary end points had to occur (event-driven analysis), requiring the randomization of at least 1200 patients. Olyaei. The initiation of lipid-lowering therapy in patients with type 2 diabetes mellitus who already have end-stage renal disease may come too late to translate into consistent improvement of the cardiovascular outcome. Pollak, B. (2013) Role of Dyslipidemia in Patients With Chronic Kidney Disease. Tomey, Jonathan A. (2015) Use of Vitamin D Receptor Activator, Incident Cardiovascular Disease and Death in a Cohort of Hemodialysis Patients. Kasiske, David C. Thompson. (2015) Comparative Effectiveness of Statin Therapy in Chronic Kidney Disease and Acute Myocardial Infarction: A Retrospective Cohort Study. Vaziri. CrossRef 296 W. (2016) Antihypertensive Medication in Patients Pre- and Postdialysis: Still Hazy After All These Years. Ueda, K. J. Stel, F. CrossRef 116 David D. Management of Overt Diabetic Kidney Disease and Uremia. Parekh. The American Journal of the Medical Sciences 345:2, 104-111. Slim, Paul D. Journal of the Korean Medical Association 56, 576. (2014) Diagnosis and Treatment of Diabetic Kidney Disease. (2016) Statin therapy across the lifespan: evidence in major age groups. Long-term follow-up endorses the original conclusions of the 4D Study. CrossRef 273 L. Handbook of Dialysis Therapy, 655-659. Spertus, Theresa I. CrossRef 285 Kunitoshi Iseki. (2013) Novel techniques and innovation in blood purification: a clinical update from Kidney Disease: Improving Global Outcomes. CrossRef 220 Ioannis Tentzeris, Miklos Rohla, Rudolf Jarai, Serdar Farhan, Matthias K. CrossRef 398 Venkatesh Kumar Ariyamuthu, Sudarshan Balla, Kunal Chaudhary. (2013) Serum lipids and prevention of atherosclerotic cardiovascular events in hemodialysis patients. S. CrossRef 86 Nosratola D. Abstract Background Statins reduce the incidence of cardiovascular events in persons with type 2 diabetes mellitus. Kalantar-Zadeh. Krane, M. Prevention and Management of Cardiovascular Disease in Kidney Disease and Kidney Failure. (2015) Meta-analysis of statin therapy in maintenance dialysis patients. The rate of fatal and nonfatal stroke decreased from 2. 21 patients), whereas in the present study, it increased from 7. Conclusions Atorvastatin had no statistically significant effect on the composite primary end point of cardiovascular death, nonfatal myocardial infarction, and stroke in patients with diabetes receiving hemodialysis. Ray. Ohya, F. Stork, C. CrossRef 256 Eiichiro Kanda, Masumi Ai, Asami Iwamoto, Mitsuyo Okazaki, Yoshitaka Maeda, Sei Sasaki, Masayuki Yoshida. Hakim. Ananth Karumanchi, Christoph Wanner, Anders H. 2013. (2013) The beneficial effects of statins in patients undergoing hemodialysis. CrossRef 198 Stein Ivar Hallan. CrossRef 403 Darren Green, Rosica Panayotova, James P. (2015) KDOQI US Commentary on the 2013 KDIGO Clinical Practice Guideline for Lipid Management in CKD. (2013) Relationship between Icodextrin use and decreased level of small low-density lipoprotein cholesterol fractioned by high-performance gel permeation chromatography. 2017. CrossRef 355 Michiel G. CrossRef 359 The EVOLVE Trial Investigators. Drechsler, J. One person in the central laboratory who had access to the randomization code controlled the changes in dose. CrossRef 165 Teruyoshi Kume, Shiro Uemura. (2015) Statins stimulate atherosclerosis and heart failure: pharmacological mechanisms. (2014) Cardiovascular Risk Factors and Chronic Kidney Disease—FGF23: A Key Molecule in the Cardiovascular Disease. Clinical Journal of the American Society of Nephrology. CrossRef 302 Adeera Levin, William Lancashire, Robert G. (2015) National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 1—Full Report. Ridker, J. Berg, C. Journal of the Japanese Coronary Association 22:3, 181-184. Viljoen, A. CrossRef 348 Rod Passman. CrossRef 15 Luca Visconti, Salvatore Benvenga, Antonio Lacquaniti, Valeria Cernaro, Annamaria Bruzzese, Giovanni Conti, Michele Buemi, Domenico Santoro. CD28null T Cells May Increase the Risk of an Atherosclerotic Vascular Event Shortly after Kidney Transplantation. Ritz, A. CrossRef 245 Ming-Hsien Tsai, Yu-Wei Fang, Jyh-Gang Leu. T. 2012. Advancing Medicine with Food and Nutrients, Second Edition, 467-480. Lipid Levels At randomization, the median level of LDL cholesterol was 121 mg per deciliter (3. (2013) Risk factors for atherosclerosis in patients with chronic kidney disease: recognition and management. (2016) Lipid disorders in patients with renal failure: Role in cardiovascular events and progression of chronic kidney disease. (2014) Effect of Time on Dialysis and Renal Transplantation on Endothelial Function. 2013. Quantitative determination of high-, low-, and very-low-density lipoproteins and lipoprotein(a) by agarose gel electrophoresis and enzymatic cholesterol staining. CrossRef 269 (2013) Chapter 2: Pharmacological cholesterol-lowering treatment in adults. By posting on any of these social media sites, you are bound by our legal terms of use. Tannock. Paneni, F. (2014) Hemodialysis. Randomized controlled trial on the efficacy and safety of atorvastatin in patients with type 2 diabetes on hemodialysis (4D Study): demographic and baseline characteristics. 2015. CrossRef 155 Darlene Dobkowski, Mandy E. Schweigert, C. Khavandi, D. Of nominal significance, more cases of fatal stroke occurred in the atorvastatin group (27) than in the placebo group (13). The Kidney Care Resource Chosen by 7 Million People. e11. CrossRef 335 Daisuke Koya, Vito M Campese. Smyth, S. The Journal of Steroid Biochemistry and Molecular Biology. H. M. Spasovski. (2016) Modulation of stroke risk in chronic kidney disease. CrossRef 31 C. Murthy, Sanjay Divakaran, Khurram Nasir, Luis Henrique W. CrossRef 313 Eun-Hee Jang, Yong-Moon Park, Joon Hur, Mee-Kyoung Kim, Seung-Hyun Ko, Ki-Hyun Baek, Ki-Ho Song, Kwang-Woo Lee, Hyuk-Sang Kwon. CrossRef 122 Takasuke Asakawa, Toshihide Hayashi, Yuri Tanaka, Nobuhiko Joki, Hiroki Hase. Lipid lowering efficacy of atorvastatin. Wake, S. ), but no cases of rhabdomyolysis or severe liver disease were detected in either group. (2013) Cardiovascular disease in end-stage renal disease. CrossRef 110 Inga Soveri, Jaak Kals. The complete absence of a stroke benefit and the increase in fatal strokes contribute considerably to the finding that the treatment effect on the primary end point was less than predicted. CrossRef 244 Rika Jimbo, Tatsuo Shimosawa. Giachelli. (2015) Primary Care of the Patient with Chronic Kidney Disease. (2016) Oral P2Y. Data were recorded at four weeks and then every six months. Shimizu, Y. Murray, Stephen Seliger, John C. Nichols. (2012) Management of Dyslipidemias in the Presence of the Metabolic Syndrome or Type 2 Diabetes. B. Heinze, K. However, the benefit of statins in such patients receiving hemodialysis, who are at high risk for cardiovascular disease and death, has not been examined. CrossRef 105 Ling Sun, Luxi Zou, Maojie Chen, Bicheng Liu. Wanner. CrossRef 247 Baris Afsar, Kultigin Turkmen, Adrian Covic, Mehmet Kanbay. Zoccali, K. Hou, J. Kees Hovingh, Rachel Laskey, Liffert Vogt, David A. Pilz, S. Alp Ikizler, Sergio Fazio. Kalra. Hammer, V. Clinical epidemiology of cardiovascular disease in chronic renal disease. (2016) Dyslipidemia in patients with chronic kidney disease. (2013) Clinical significance of subclinical carotid atherosclerosis and its relationship with echocardiographic parameters in non-diabetic chronic kidney disease patients. Every end point was adjudicated by three members of the end-point committee, on the basis of predefined criteria that are part of the study protocol. Evans, Christopher J. CrossRef 400 Myles Wolf. 2017. CrossRef 211 Cynthia Herrick, Marina Litvin, Anne Carol Goldberg. J. CrossRef 385 Yelena Slinin, Areef Ishani, Thomas Rector, Patrick Fitzgerald, Roderick MacDonald, James Tacklind, Indulis Rutks, Timothy J. (2016) Arrhythmia and Sudden Death in Hemodialysis Patients: Protocol and Baseline Characteristics of the Monitoring in Dialysis Study. (2016) Reduced risk of myocardial infarct and revascularization following coronary artery bypass grafting compared with percutaneous coronary intervention in patients with chronic kidney disease. Titze, Matthias Schmid, Jennifer Nadal, Georg Schlieper, Martin Busch, Seema Baid-Agrawal, Vera Krane, Christoph Wanner, Florian Kronenberg, Kai-Uwe Eckardt, on behalf of the GCKD Study Investigators. (2016) Special considerations for the treatment of chronic kidney disease in the elderly. Thereafter, eligible patients were randomly assigned to double-blind treatment with either atorvastatin at a dose of 20 mg once daily or matching placebo. (2013) Meta-Analysis of Lipid-Lowering Therapy in Maintenance Dialysis Patients. 2014. P. A. Adjustments were made for sex, age, and baseline status with respect to coronary heart disease. Ferro. Zoccali. Hochman, Thomas N. A computer-generated randomization code was prepared by a central Pfizer unit that was independent of local study personnel. CrossRef 10 Harald Binder, Thorsten Kurz, Sven Teschner, Clemens Kreutz, Marcel Geyer, Johannes Donauer, Annette Kraemer-Guth, Jens Timmer, Martin Schumacher, Gerd Walz. Kaysen. Salusky. The primary end points were evaluated according to time-to-event analysis. 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(2016) A lipidologist perspective of global lipid guidelines and recommendations, part 2: Lipid treatment goals. Rosenkranz, Kathrin Eller, Philipp Eller. Ruf, B. Higa, M. Qunibi. Henze, K. Kiefer, Michael J. Thaw out with warm seasonal eats such as Pumpkin Chili and Gingerbread Apple Cobbler from the new DaVita cookbook. CrossRef 92 Yuexin Tang, John M. Apolipoprotein B, fibrinogen, HDL cholesterol, and apolipoprotein(a) phenotypes predict coronary artery disease in hemodialysis patients. (2012) Novel Strategies for Managing Dyslipidemia: Treatment beyond Statins. CrossRef 66 Julia Arnold, Don Sims, Charles J. Serum lipids predict cardiac death in diabetic patients on maintenance hemodialysis: results of a prospective study. Mark, Alan G. (2012) Targeted complement inhibition as a promising strategy for preventing inflammatory complications in hemodialysis. (2014) Critical Appraisal of the SHARP Trial: The Results May Be Dull. Santosh Pai, Sreedhar Reddy, Parul Kodan. 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(2016) Austrian Lipid Consensus on the management of metabolic lipid disorders to prevent vascular complications. All analyses of primary and secondary end points were based on the classification by the end-point committee that was agreed on by consensus or majority vote. Immunohistochemical detection of imidazolone and N(epsilon)-(carboxymethyl) lysine in aortas of hemodialysis patients. 18 Times to an event for patients without a primary end point or competing event were treated as censored and were calculated as the time from randomization to the date of the last contact. Hetzel, Werner Kleophas, Frank Dellanna, Malte Kelm, Tienush Rassaf. 2012. (2014) Une autre histoire du sevelamer. Bell. The data were monitored and collected by two contract research organizations supported by Pfizer, one of which (Datamap) holds the data. Written informed consent was obtained from all patients. A. Herrington, Alan G. CrossRef 61 Sudeepta Dandapat, Jennifer G. Cohen, R. Yamazato, K. First, we showed that it is difficult to rely on uncontrolled observational studies that show substantial advantages of statins in the treatment of patients receiving hemodialysis. 26 in which intensive lipid-lowering therapy with atorvastatin at a dose of 80 mg per day was more effective than a dose of 10 mg per day in patients with stable coronary heart disease. CrossRef 254 Jwa-Kyung Kim, Young Rim Song, Min Gang Kim, Hyung Jik Kim, Sung Gyun Kim. This calculation was based on observational studies. Kashyap, N. Dekker, C. Death from other causes was treated as a competing event, and for patients who died from other causes, follow-up was censored as of the date of death. USRDS 2003 annual data report: atlas of end-stage renal disease in the United States. A Cohort Study from a Chinese Dialysis Center in a University Hospital. Winkelmayer. 9,27 Second, and more important, is the conclusion that the benefit of atorvastatin is limited when intervention with statins is postponed until patients have reached end-stage renal disease. CrossRef 299 Marcin Barylski, Shekoufeh Nikfar, Dimitri P. Toth. (2014) AGE-Breaker ALT-711 Plus Insulin Could Restore Erectile Function in Streptozocin-Induced Type 1 Diabetic Rats. CrossRef 259 Andreas Schneider, Markus P Schneider, Hubert Scharnagl, Alan G Jardine, Christoph Wanner, Christiane Drechsler. CrossRef 278 Suetonia C Palmer, Sankar D Navaneethan, Jonathan C Craig, David W Johnson, Vlado Perkovic, Sagar U Nigwekar, Jorgen Hegbrant, Giovanni FM Strippoli, Giovanni FM Strippoli. Maisch, C. Tokashiki, H. CrossRef 127 Luca Di Lullo, Andrew House, Antonio Gorini, Alberto Santoboni, Domenico Russo, Claudio Ronco. Journal of the American College of Cardiology 61:23, e179-e347. (2014) Is left ventricular hypertrophy a modifiable risk factor in end-stage renal disease. The plan for the statistical analysis was completed before the database was locked and unblinded. (2013) Inverse relationship between long-chain n-3 fatty acids and risk of sudden cardiac death in patients starting hemodialysis. Higgins, C. CrossRef 203 Roger Rear, Pascal Meier, Robert M. CrossRef 320 Joost Besseling, Julian Capelleveen, John J. (2016) Predictors of atherosclerotic events in patients on haemodialysis. A resting electrocardiogram was recorded every six months and evaluated by independent cardiologists from the electrocardiographic monitoring board, according to the Minnesota classification system for the electrocardiogram (codes 1-1-1 through 9-2 for QRS-complex, ST-segment, or T-wave changes). CrossRef 138 Toshiyuki Nakao, Masaaki Inaba, Masanori Abe, Kazo Kaizu, Kenji Shima, Tetsuya Babazono, Tadashi Tomo, Hideki Hirakata, Tadao Akizawa,. Tana, A. During the study, 98 patients in the placebo group (15 percent) began nonstudy statins, as compared with 10 percent of those in the atorvastatin group. CrossRef 117 S. (2014) The Risk-Benefit Paradigm vs the Causal Exposure Paradigm: LDL as a primary cause of vascular disease. W. Jager, S. (2016) Comparison of the efficacy and safety of intensive-dose and standard-dose statin treatment for stroke prevention. CrossRef 4 Matthew R. Carini, G. Nicholls, Maciej Banach. Hod, S. Jose, Charlotte McKercher. Heimburger, K. CrossRef 294 Charles Chazot, Guillaume Jean. (2014) Clinical evidence of statin therapy in non-dyslipidemic disorders. CrossRef 184 Suetonia C Palmer, Giovanni FM Strippoli, Jonathan C Craig. (2013) Impact of Improving Quality of Dialysis Fluid on Oxidative Stress and Lipid Profile in Hemodialysis Patients. Computed tomographic or magnetic resonance imaging of the brain was recommended and available in all but 16 cases. 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(2013) The quality of cardiovascular disease care for adolescents with kidney disease: a Midwest Pediatric Nephrology Consortium study. Specifically, the ethical implications of the inclusion of a placebo group — that is, of not providing lipid-lowering medications to those randomly assigned to the control group — were taken into account and considered acceptable. Virgil Brown. (2014) Statin Therapy in Patients With Chronic Kidney Disease Undergoing Percutaneous Coronary Intervention (from the Evaluation of Drug Eluting Stents and Ischemic Events Registry). CrossRef 195 Peter F. CrossRef 361 Muriel Ghosn, Fuad N. Ryan. Attend a No-Cost Kidney Health Education Class in Your Neighborhood. CrossRef 306 Yuya Matsue, Makoto Suzuki, Wataru Nagahori, Masakazu Ohno, Akihiko Matsumura, Yuji Hashimoto. Bethesda, Md. R. The Parathyroids in Renal Disease. (2015) Nephrology research—the past, present and future. (2016) Percutaneous coronary intervention in patients with hemodialysis. 2015. 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This result was driven mainly by differences in the rates of coronary-artery bypass grafting and percutaneous transluminal coronary angioplasty. Norris. (2016) Triglyceride to high-density lipoprotein cholesterol ratio predicts cardiovascular events in maintenance hemodialysis patients. CrossRef 91 Terry A. (2012) Dysfunctional High-Density Lipoprotein in Patients on Chronic Hemodialysis. Swan, Tom Puchalski, Pat Mitchell, Connie Azumaya, Julie Zalikowski, Yi Wang. H. Stendahl. Bots, Muriel P. Virgil Brown. Ahn, Michel F. Basnakian, Mohan Rajapurkar. Neurologic Complications of Chronic Kidney Disease. CrossRef 377 Suguru Yamamoto, Patricia G. Erythropoiesis stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. (2014) Lipid lowering in liver and chronic kidney disease. (2015) Feasibility study of colestipol as an oral phosphate binder in hemodialysis patients. Darryl Quarles. 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