The effect of fluvastatin on cardiac outcomes in patients with moderate to severe renal insufficiency: A pooled analysis of double-blind, randomized trials

International Journal of Cardiology

Volumn 117, Issue 1, 2007, Pages 64-74

  Holdaas, Hallvard ^a   Wanner, Christoph ^b   Abletshauser, Claudia ^c   Gimpelewicz, Claudio ^d   Isaacsohn, Jonathan ^e  

^a UNIVERSITY OF OSLO   (Norway)

^b UNIVERSITY HOSPITAL WÜRZBURG   (Germany)

^c NOVARTIS PHARMA GMBH   (Germany)

^d NOVARTIS PHARMA AG   (Switzerland)

^e Medpace Inc ^*  (United States)

Author keywords

Cardiovascular disease; Clinical endpoints; Fluvastatin; Renal insufficiency

Indexed keywords

CREATININE; FLUINDOSTATIN; PLACEBO;

ADULT; ARTICLE; BASAL CELL CARCINOMA; CANCER; CARDIOVASCULAR DISEASE; CHRONIC KIDNEY FAILURE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE CLEARANCE; DEPRESSION; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DYSPEPSIA; DYSURIA; FEMALE; HAZARD ASSESSMENT; HEART ATRIUM FIBRILLATION; HEART DEATH; HEART INFARCTION; HEMATURIA; HUMAN; INSOMNIA; KIDNEY FUNCTION; LIPID BLOOD LEVEL; MALE; MUSCLE CRAMP; MYALGIA; MYOPATHY; NAUSEA; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; RHABDOMYOLYSIS; RISK REDUCTION; SAMPLE SIZE; THERAPY EFFECT; TREATMENT OUTCOME; TREATMENT RESPONSE; UREMIA;

ANTICHOLESTEREMIC AGENTS; CHOLESTEROL, LDL; COMORBIDITY; DEATH, SUDDEN, CARDIAC; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FATTY ACIDS, MONOUNSATURATED; FEMALE; HUMANS; HYPERLIPIDEMIAS; INCIDENCE; INDOLES; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; RANDOMIZED CONTROLLED TRIALS; RENAL INSUFFICIENCY, CHRONIC; RISK FACTORS; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 33947190492     PISSN: 01675273     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijcard.2006.06.003     Document Type: Article

References (15)

1. Levey A.S., Beto J.A., Coronado B.E., et al. Controlling the epidemic of cardiovascular disease in chronic renal disease: what do we know? What do we need to learn? Where do we go from here? National Kidney Foundation Task Force on Cardiovascular Disease. Am J Kidney Dis 32 (1998) 853-906
2. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. US Renal Data System, USRDS 1998 Annual Data Report. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 1998.
3. Moore R. Therapeutic considerations for the use of statin therapy in chronic renal disease. Nephron, Clin Pract 95 (2003) c107-c115
4. Sarnak M.J., Levey A.S., Schoolwerth A.C., et al. American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Circulation 108 (2003) 2154-2169
5. Harris K., Thomas M., Short C., and Moore R. Assessment of the efficiency of treatment of dyslipidaemia in renal outpatients. J Nephrol 15 (2002) 263-269
6. Kasiske B.L. Hyperlipidemia in patients with chronic renal disease. Am J Kidney Dis 32 5 Suppl 3 (1998) S142-S156
7. Lechleitner M. Dyslipidemia and renal disease-pathophysiology and lipid lowering therapy in patients with impaired renal function. J Clin Basic Cardiol 3 (2000) 3-6
8. Fathi R., Isbel N., Short L., Haluska B., Johnson D., and Marwick T.H. The effect of long-term aggressive lipid lowering on ischemic and atherosclerotic burden in patients with chronic kidney disease. Am J Kidney Dis 43 (2004) 45-52
9. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for industry: pharmacokinetics in patients with impaired renal function-study design, data analysis, and impact on dosing and labeling. May 1998.
10. Holdaas H., Fellstrom B., Jardine A.G., et al. Assessment of LEscol in Renal Transplantation (ALERT) Study Investigators. Effect of fluvastatin on cardiac outcomes in renal transplant recipients: a multicentre, randomised, placebo-controlled trial. Lancet 361 (2003) 2024-2031
11. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002;360:7-22.
12. Sever P.S., Dahlof B., Poulter N.R., et al. ASCOT investigators. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet 361 (2003) 1149-1158
13. Tonelli M., Moye L., Sacks F.M., Kiberd B., and Curhan G. Cholesterol and Recurrent Events (CARE) Trial Investigators. Pravastatin for secondary prevention of cardiovascular events in persons with mild chronic renal insufficiency. Ann Intern Med 138 (2003) 98-104
14. Tonelli M., Isles C., Curhan G.C., et al. Effect of pravastatin on cardiovascular events in people with chronic kidney disease. Circulation 110 (2004) 1557-1563
15. Wanner C., Krane V., März W., et al. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med 353 (2005) 238-248