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No Difference between N-Acetylcysteine and Fenoldopam for Thwarting Contrast-Induced Nephropathy: Presented at AHA

By Jill Stein

NEW ORLEANS, LA -- November 8, 2004 -- A randomized study failed to show a significant difference in the ability of oral N-acetylcysteine (NAC) and intravenous fenoldopam (FEN) to prevent the deterioration in renal function or the rate of contrast-induced nephropathy after contrast dye administration during cardiac catheterization.

The data were reported here on November 6th at the American Heart Association Scientific Sessions 2004 by Tien M.H. Ng, PharmD, and a group with the University of Nebraska in Omaha. Dr. Ng is currently assistant clinical professor of medicine, University of Southern California, Los Angeles, California.

In the study, cardiac catheterization patients with preexisting stable renal insufficiency were randomized to receive NAC 600 mg orally twice daily for 4 doses or FEN 0.1 mcg/kg/min intravenously for a minimum of 8 hours.

Randomization included stratification for diabetes. Non-insulin-dependent subjects received concomitant intravenous hydration with 0.9% sodium chloride at a rate of 1 mL/kg/hr; insulin-dependent patients were given 5% dextrose in normal saline.

The study was stopped after 95 patients (mean age 68 years, 25% female, 42% diabetic, mean baseline serum creatinine 1.5 ±0.4 mg/L) were randomized; 84 patients completed follow-up.

Overall, there were no differences between NAC and FEN in the mean change in serum creatinine at 72 hours (0.20 ±0.72 vs 0.08 ±0.48 mg/L, respectively, P = 0.4) or the incidence of contrast-induced nephropathy (5 vs 8, P = 0.4) between the 2 therapies.

The similarity in efficacy was consistent regardless of diabetic status, gender, baseline renal function, age, or contrast volume.

Dr. Ng cautioned that the study was limited by its early termination, the level of baseline renal insufficiency, the absence of a placebo or combination comparison, and the fact that it was insufficiently powered to determine the optimal FEN dose.

Contrast-induced nephropathy refers to an acute impairment of renal function occurring 24 to 48 hours and up to 5 days after the administration of radiographic contrast dye. The reported incidence of this complication varies between 4% and 70%, and its development has been linked to significant morbidity and mortality. Contrast material exerts multiple effects on renal physiology that can contribute to impaired renal function, including vasoconstrictive decreases in renal perfusion and oxidative renal damage.


[Presentation title: Randomized Comparison of Oral N-Acetylcysteine to Intravenous Fenoldopam for the Prevention of Contrast-Induced Nephropathy (CAFCIN Study). Abstract 1796]

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