Recent clinical trials of pharmacologic cardiovascular interventions in patients with chronic kidney disease

Reviews on Recent Clinical Trials

Volumn 3, Issue 2, 2008, Pages 79-88

  Kaisar, M O ^a   Isbel, N M ^a   Johnson, David W ^a  

^a UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

Anti oxidants; Chronic; Erythropoiesis stimulating agents; Kidney failure; Outcomes; Randomized controlled trials; Statins

Indexed keywords

ACETYLCYSTEINE; ACETYLSALICYLIC ACID; ALPHA TOCOPHEROL; ANTIOXIDANT; ATORVASTATIN; CALCIUM; CARVEDILOL; CINACALCET; CLOPIDOGREL; CYANOCOBALAMIN; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ERYTHROPOIETIN; FLUINDOSTATIN; FOLIC ACID; FOSINOPRIL; GEMFIBROZIL; HEMOGLOBIN; HOMOCYSTEINE; PHOSPHATE; PHOSPHATE BINDING AGENT; PLACEBO; PRAVASTATIN; PYRIDOXINE; RAMIPRIL; RECOMBINANT ERYTHROPOIETIN; ROSUVASTATIN; SEVELAMER; TELMISARTAN; TRIACYLGLYCEROL; UNINDEXED DRUG; CARDIOVASCULAR AGENT; HEMATOLOGIC AGENT;

ANEMIA; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CHRONIC KIDNEY FAILURE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CORONARY ARTERY BYPASS GRAFT; DISEASE ASSOCIATION; DRUG DOSE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DYSLIPIDEMIA; GASTROINTESTINAL HEMORRHAGE; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HEMATOCRIT; HEMODIALYSIS; HUMAN; HYPERPHOSPHATEMIA; HYPERTRIGLYCERIDEMIA; ISCHEMIC HEART DISEASE; KIDNEY TRANSPLANTATION; LOW DRUG DOSE; MEDICAL RESEARCH; MORTALITY; OUTCOME ASSESSMENT; PANCREATITIS; PERITONEAL DIALYSIS; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; RISK BENEFIT ANALYSIS; RISK FACTOR; TRANSLUMINAL CORONARY ANGIOPLASTY; TREATMENT OUTCOME;

CARDIOVASCULAR AGENTS; CARDIOVASCULAR DISEASES; CLINICAL TRIALS AS TOPIC; HEMATOLOGIC AGENTS; HUMANS; KIDNEY FAILURE, CHRONIC; RISK FACTORS;

EID: 46749104551     PISSN: 15748871     EISSN: None     Source Type: Journal    
DOI: 10.2174/157488708784223853     Document Type: Review

References (69)

1. McDonald S, Excell L. ANZDATA Registry Report 2005. Australian and New Zealand Dialysis and Transplant Registry, Adelaide, South Australia, 2006.
2. United States Renal Data Systems. Annual Data Report USRDS, Minneapolis, MN, 2006.
3. Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med 2004; 351: 1296-305.
4. Foley RN, Parfrey PS, Sarnak MJ. Clinical epidemiology of cardiovascular disease in chronic renal disease. Am J Kidney Dis 1998; 32: S112-9.
5. Weiner DE, Tighiouart H, Amin MG, et al. Chronic kidney disease as a risk factor for cardiovascular disease and all-cause mortality: a pooled analysis of community-based studies. J Am Soc Nephrol 2004; 15: 1307-15.
6. Bozbas A, Atar I, Yildirir A, et al. Prevalence and predictors of arrhythmia in end-stage renal disease patients on hemodialysis. Ren Fail 2007; 29: 331-9.
7. Foley RN, Herzog CA, Collins AJ. Smoking and cardiovascular outcomes in dialysis patients: the United States Renal Data System Wave 2 study. Kidney Int 2003; 63: 1462-7.
8. Sommerer C, Beimler J, Schwenger V, et al. Cardiac biomarkers and survival in hemodialysis patients. Eur J Clin Invest 2007; 37: 350-6.
9. Parfrey PS, Foley RN, Harnett JD, et al. Outcome and risk factors for left ventricular disorders in chronic uraemia. Nephrol Dial Transplant 1996; 11: 1277-85.
10. Keough-Ryan TM, Kiberd BA, Dipchand CS, et al. Outcomes of acute coronary syndrome in a large Canadian cohort: impact of chronic renal insufficiency, cardiac interventions, and anemia. Am J Kidney Dis 2005; 46: 845-55.
11. Kennedy R, Case C, Fathi R, et al. Does renal failure cause an atherosclerotic milieu in patients with end- stage renal disease? Am J Med 2001; 110: 198-204
12. Coca SG, Krumholz HM, Garg AX, Parikh CR. Under representation of renal disease in randomized controlled trials of cardiovascular disease. JAMA 2006; 296: 1377-84
13. Foley RN, Parfrey PS, Harnett JD, et al. Impact of hypertension on cardiomyopathy, morbidity and mortality in end-stage renal disease. Kidney Int 1996; 49: 1379-85.
14. Ma JZ, Ebben J, Xia H, Collins AJ. Hematocrit level and associated mortality in hemodialysis patients. J Am Soc Nephrol 1999; 10: 610-9.
15. Madore F, Lowrie EG, Brugnara C, et al. Anemia in hemodialysis patients: variables affecting this outcome predictor. J Am Soc Nephrol 1997; 8: 1921-9.
16. Besarab A, Bolton WK, Browne JK, et al. The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N Engl J Med 1998; 339: 584-90.
17. Singh AK, Szczech L, Tang KL, et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006; 355: 2085-98.
18. Drueke TB, Locatelli F, Clyne N, et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006; 355: 2071-84.
19. Phrommintikul A, Haas SJ, Elsik M, Krum H. Mortality and target haemoglobin concentrations in anaemic patients with chronic kidney disease treated with erythropoietin: a meta-analysis. Lancet 2007; 369: 381-8.
20. Tobu M, Iqbal O, Fareed D, et al. Erythropoietin-induced thrombosis as a result of increased inflammation and thrombin activatable fibrinolytic inhibitor. Clin Appl Thromb Hemost 2004; 10: 225-32.
21. Taylor JE, McLaren M, Henderson IS, Belch JJ, Stewart WK. Prothrombotic effect of erythropoietin in dialysis patients. Nephrol Dial Transplant 1992; 7: 235-9.
22. Vaziri ND. Mechanism of erythropoietin-induced hypertension. Am J Kidney Dis 1999; 33: 821-8.
23. IV. NKF-K/DOQI Clinical Practice Guidelines for Anemia of Chronic Kidney Disease: update 2000. Am J Kidney Dis 2001; 37: S182-S238.
24. Tonelli M, Isles C, Curhan GC, et al. Effect of pravastatin on cardiovascular events in people with chronic kidney disease. Circulation 2004; 110: 1557-63.
25. Wanner C, Krane V, Marz W, et al. Atosvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med 2005; 353: 238-48.
26. Stegmayr B, Brannstrom M, Bucht B, et al. Low-dose atorvastatin in severe chronic kidney disease patients: a ramdomized, controlled end-point study. Scand J Urol Nephrol 2005; 39: 489-97.
27. Holdaas H, Fellstrom BC, Jardine AG, et al. Effect of fluvastatin on cardiac outcomes in renal transplant recipients: a multicentre, randomised, placebo-controlled trial. Lancet 2003; 361: 2024-31.
28. Holdaas H, Fellstrom BC, Cole E, et al. Long-term cardiac outcomes in renal transplant recipients receiving fluvastatin: the ALERT extension study. Am J Transplant 2005; 5: 2929-36.
29. Landray M, Baigent C, Leaper C, et al. 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 2006; 47: 385-95.
30. Fellstrom BC, Zannad F, Schmieder R, Holdaas H, Jardine AG. Effect of rosuvastatin on outcomes in chronic haemodialysis patients - design and rationale of the AURORA study. Curr Control Trials Cardiovasc Med 2005; 6: 9.
31. Tonelli M, Collins D, Robins S, Bloomfield H, Curhan GC. Gemfibrozil for secondary prevention of cardiovascular events in mild to moderate chronic renal insufficiency. Kidney Int 2004; 66: 1123-30.
32. Kalantar-Zadeh H, Block G, Humphreys MH, Kopple JD. Reverse epidemiology of cardiovascular risk factors in maintenance dialysis patients. Kidney Int 2003; 63: 793-808.
33. Wrone EM, Hornberger JM, Zehnder JL, et al. Randomized trial of folic acid for prevention of cardiovascular events in end-stage renal disease. J Am Soc Nephrol 2004; 15: 420-6.
34. Suliman ME, Qureshi AR, Barany P, et al. Hyperhomocysteinemia, nutritional status, and cardiovascular disease in hemodialysis patients. Kidney Int 2000; 57: 1727-35.
35. Righetti M, Ferrario GM, Milani S, et al. Effects of folic acid treatment on homocysteine levels and vascular disease in hemodialysis patients. Med Sci Monit 2003; 9: 119-24.
36. Vianna AC, Mocelin AJ, Matsuo T, et al. Uremic hyperhomocysteinemia: a randomized controlled trial of folate treatment for the prevention of cardiovascular events. Hemodial Int 2007; 11: 210-6.
37. Zoungas S, McGrath BP, Branley P, et al. Cardiovascular morbidity and mortality in the Atherosclerosis and Folic Acid Supplementation Trial (ASFAST) in chronic renal failure: a multicenter, randomized, controlled trial. J Am Coll Cardiol 2006; 47: 1108-16.
38. Righetti M, Serbelloni P, Milani S, Ferrario GM. Homocysteine-lowering vitamin B treatment decreases cardiovascular events in hemodialysis patients. Blood Purif 2006; 24: 379-86.
39. Jamison RL, Hartigan P, Gaziano JM, et al. Design and statistical issues in the homocysteinemia in kidney and end-stage renal disease (HOST) study. Clin Trials 2004; 1: 451-60.
40. Zannad F, Kessler M, Lehert P, et al. Prevention of cardiovascular events in end-stage renal disease: results of a ramdomized controlled trial of fosinopril and implications for future studies. Kidney Int 2006; 70: 1318-24
41. Cice G, Ferrara L, D'Andrea A, et al. Carvedilol increases two-year survival in dialysis patients with dilated cardiomyopathy: a prospective, placebo-controlled trial. J Am Coll Cardiol 2003; 41: 1438-44.
42. Block GA, Klassen PS, Lazarus JM, et al. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol 2004; 15: 2208-18.
43. Cunningham J, Danese M, Olson K, Klassen P, Chertow GM. Effects of the calcimimetic cinacalcet HCI on cardiovascular disease, fracture, and health-related quality of life in secondary hyperparathyroidism. Kidney Int 2005; 68: 1793-800.
44. Block G, Spiegel DM, Ehrlich J, et al. Effects of sevelamer and calcium on coronary artery calcification in patients new to hemodialysis. Kidney Int 2005; 68: 1815-24.
45. Asmus HG, Braun J, Krause R, et al. Two year comparison of sevelamer and calcium carbonate effects on cardiovascular calcification and bone density. Nephrol Dial Transplant 2005; 20: 1653-61.
46. Chertow GM, Burke SK, Raggi P. Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int 2002; 62: 245-52.
47. Block G, Raggi P, Bellasi A, Kooienga L, Spiegel DM. Mortality effect of coronary calcification and phosphate binder choice in incident hemodialysis patients. Kidney Int 2007; 71: 438-41.
48. Suki W, Zabaneh R, Cangiano J. The DCOR trial - a prospective, randomized trial assessing the impact on outcomes of sevelamer in dialysis patients. J Am Soc Nephrol 2005; 16: P0745.
49. Tepel M, Echelmeyer M, Orie NN, Zidek W. Increased intracellular reactive oxygen species in patients with end-stage renal failure: effect of hemodialysis. Kidney Int 2000; 58: 867-72.
50. Becker BN, Himmelfarb J, Henrich WL, Hakim RM. Reassessing the cardiac risk profile in chronic hemodialysis patients: a hypothesis on the role of oxidant stress and other non-traditional cardiac risk factors. J Am Soc Nephrol 1997; 8: 475-86.
51. Boaz M, Matas Z, Biro A, et al. Serum malondialdehyde and prevalent cardiovascular disease in hemodialysis. Kidney Int 1999; 56: 1078-83.
52. Tepel M, van der GM, Statz M, Jankowski J, Zidek W. The antioxidant acetylcysteine reduces cardiovascular events in patients with end-stage renal failure: a randomized, controlled trial. Circulation 2003; 107: 992-5.
53. Boaz M, Smetana S, Weinstein T, et al. Secondary prevention with antioxidants of cardiovascular disease in endstage renal disease (SPACE): randomised placebo-controlled trial. Lancet 2000; 356: 1213-8.
54. Yusuf S, Dagenais G, Pogue J, Bosch J, Sleight P. Vitamin E supplementation and cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation study investigators. N Engl J Med 2000; 342: 154-60.
55. Nanayakkara PW, van Guldener C, ter Wee PM, et al. Effect of a treatment strategy consisting of pravastatin, vitamin E and homocysteine lowering on carotid intima-media thickness, endothelial function and renal function in patients with mild to moderate chronic kidney disease: results from the Anti-oxidant Therapy in Chronic renal insufficiency (ATIC) study. Arch Intern Med 2007; 167: 1262-70.
56. Ruilope LM, Salvetti A, Jamerson K, et al. Renal function and intensive lowering of blood pressure in hypertensive participants of the hypertension optimal treatment (HOT) study. J Am Soc Nephrol 2001; 12: 218-25.
57. Kaufman JS, O'Connor TZ, Zhang JH, et al. Randomized controlled trial of clopidogrel plus aspirin to prevent hemodialysis access graft thrombosis. J Am Soc Nephrol 2003; 14: 2313-21.
58. Baigent C, Landray M, Leaper C, et al. 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 2005; 45: 473-84.
59. McCullough PA, Sandberg KR, Borzak S, et al. Benefits of aspirin and beta-blockade after myocardial infarction in patients with chronic kidney disease. Am Heart J 2002; 144: 226-32.
60. Berger AK, Duval S, Krumholz HM. Aspirin, beta-blocker, and angiotensin-converting enzyme inhibitor therapy in patients with end-stage renal disease and an acute myocardial infarction. J Am Coll Cardiol 2003; 42: 201-8.
61. Curtis BM, Levis A, Parfrey PS. Multiple risk factor intervention in chronic kidney disease: management of cardiac disease in chronic kidney disease patients. Med Clin North Am 2005; 89: 511-23.
62. Curtis BM, Ravani P, Malberti F, et al. The short- and long-term impact of multi-disciplinary clinics in addition to standard nephrology care on patient outcomes. Nephrol Dial Transplant 2005; 20: 147-54.
63. Gaede P, Vedel P, Parving HH, Pedersen O. Intensified multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: the Steno type 2 randomised study. Lancet 1999; 353: 617-22.
64. Agewall S, Fagerberg B, Berglund G, et al. Multiple risk intervention trial in high risk hypertensive men: comparison of ultrasound intima-media thickness and clinical outcome during 6 years of follow-up. J Intern Med 2001; 249: 305-14.
65. Isbel NM, Haluska B, Johnson DW, et al. Increased targeting of cardiovascular risk factors in patients with chronic kidney disease does not improve atheroma burden or cardiovascular function. Am Heart J 2006; 151: 745-53.
66. Campean V, Neureiter D, Varga I, et al. Atherosclerosis and vascular calcification in chronic renal failure. Kidney Blood Press Res 2005; 28: 280-9.
67. Coletta AP, Cleland JG, Freemantle N, Clark AL. Clinical trials update from the European Society of Cardiology Heart Failure meeting: SHAPE, BRING-UP 2 VAS, COLA II, FOSIDIAL, BETACAR, CASINO and meta-analysis of cardiac resynchronisation therapy. Eur J Heart Fail 2004; 6: 673-6.
68. Cice G, Ferrara L, D'Andrea A, et al. Carvedilol increases two-year survivalin dialysis patients with dilated cardiomyopathy: a prospective, placebo-controlled trial. J Am Coll Cardiol 2003; 41: 1438-44
69. Boaz M, Smetana S, Weinstein T, et al. Secondary prevention with antioxidants of cardiovascular disease in endstage renal disease (SPACE): randomised placebo-controlled trial. Lancet 2000; 356: 1213-8.