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Prevention of radiocontrast medium-induced nephropathy using short-term high-dose simvastatin in patients with renal insufficiency undergoing coronary angiography (PROMISS) trial--a randomized controlled study
Cited 148 time in
Web of Science
Cited 165 time in Scopus
- Authors
- Issue Date
- 2008-02-26
- Publisher
- Elsevier
- Citation
- Am Heart J. 2008 Mar;155(3):499.e1-8. Epub 2008 Jan 30.
- Keywords
- Administration, Oral ; Aged ; Contrast Media/*adverse effects ; Coronary Angiography/*adverse effects ; Coronary Disease/complications/*radiography ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; Follow-Up Studies ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/*administration & dosage ; Incidence ; Kidney Failure/chemically induced/epidemiology/*prevention & control ; Korea/epidemiology ; Male ; Prospective Studies ; Renal Insufficiency/*complications ; Risk Factors ; Simvastatin/*administration & dosage ; Time Factors ; Treatment Outcome ; Triiodobenzoic Acids/adverse effects/diagnostic use
- Abstract
- BACKGROUND: Contrast media cause oxidative stress, which has been suggested as one possible mechanism responsible for contrast-induced nephropathy. Statins appear to have pleiotropic effects, including antioxidant properties. We investigated to determine whether simvastatin pretreatment reduces the risk of contrast-induced nephropathy in a high-risk population of patients with renal insufficiency undergoing coronary angiography. METHODS: We conducted a prospective, randomized, double-blind, placebo-controlled, 2-center trial, involving 247 consecutive patients with chronic renal insufficiency (calculated creatinine clearance < or = 60 mL/min and/or serum creatinine > or = 1.1 mg/dL) undergoing coronary angiography. Patients were randomized to simvastatin (n = 124; 160 mg total, 40 mg orally every 12 hours starting the evening before and ending the morning after the procedure) or placebo (n = 123). All patients received pre - and postprocedure hydration. The iso-osmolar contrast agent iodixanol was used for coronary angiography in all patients. RESULTS: There was no difference between simvastatin and placebo in mean peak increase in serum creatinine measured within 48 hours after coronary angiography, the primary study end point (0.002 +/- 0.164 vs 0.017 +/- 0.230 mg/mL respectively, P = .559). The incidence of contrast-induced nephropathy, a secondary end point defined as increase of either > or = 25% or > or = 0.5 mg/dL in serum creatinine, was 2.5% in simvastatin-treated patients (3/118) and 3.4% in placebo-treated patients (4/118), a nonsignificant difference (P = 1.00). There were also no differences between the 2 groups in length of hospital stay or 1- and 6-month clinical outcomes. CONCLUSIONS: Simvastatin pretreatment for short-term at high dose do not prevent renal function deterioration after administration of contrast medium in patients with baseline renal insufficiency undergoing coronary angiography.
- ISSN
- 1097-6744 (Electronic)
- Language
- English
- URI
- http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=18294484
http://www.sciencedirect.com/science?_ob=MImg&_imagekey=B6W9H-4RPVJ5P-5-7&_cdi=6683&_user=168665&_orig=search&_coverDate=03%2F31%2F2008&_sk=998449996&view=c&wchp=dGLzVzz-zSkWA&md5=1ef8ffbb3147b0dbeb2a1b1238878b30&ie=/sdarticle.pdf
https://hdl.handle.net/10371/46132
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