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| |  ASN: Fish Oil Fails to Show Advantage in Nephrotic Syndrome By Roberta Friedman, PhD SAN DIEGO, CA -- November 21, 2003 -- Fish oil failed to provide benefit over placebo or alternate-day steroid use in immunoglobulin A (IgA) nephrotic syndrome, investigators reported here November 17th at the 36th Annual Meeting of the American Society of Nephrology. The small study did find that proteinuria is "particularly important" as a prognostic indicator in these patients, said investigator Ronald Hogg, MD, presenting for the Southwest Pediatric Nephrology Study Group. A higher ratio of protein to creatinine in urine correlated with a failing glomerular filtration rate (GFR) (P =.005) and time to declining GFR of 60% of baseline (P =.009) in the trial. Dr. Hogg said that the study was extremely difficult to carry out, given findings of an earlier study at the Mayo Clinic suggesting success with fish oil. "The word 'placebo' was abhorrent [for patients]," said Dr. Hogg. Other than having no significant effect on the primary end point -- time to reduction in GFR to less than 60% of study-entry value -- the omega-3 fatty-acid supplement "truly are horse pills," said Dr. Hogg, citing that this is "an important factor in paediatric studies." The investigators had to find children willing to swallow the large pills, even though they were smaller for paediatric dosing than for adult dosing. Prednisone was taken at 60 mg/m2 every other day for the first 3 months, then tapered to 40 mg/m2 on alternate days for 9 months, followed by 12 months at 30 mg/m2. Blood pressure was maintained below the 95th percentile with enalapril, 2.5 to 40 mg a day. Patient recruitment was broadened to include increasingly older "young adults" to attempt to power the study, Dr. Hogg admitted. Patients with IgA nephropathy could be up to 41 years of age. Each group comprised about 30 patients. First morning-urine ratio of protein to creatinine had to be above 0.5. Biopsy had to show moderate to severe IgA nephropathy. GFR had to be 50 mL/min/1.73 m2. GFR fell by 60% for 2, 8 and 4 patients in the steroid, fish oil, and placebo groups respectively, over the course of the trial. Time to failure did not differ significantly among the treatments, as well -- "a very disappointing final conclusion," Dr. Hogg said. The baseline proteinuria, however, was significantly associated with the failure of GFR down the line, Dr. Hogg noted. "Many patients had a decrease in proteinuria, including [placebo-treated study participants]," he said. Patients taking fish oil turned out to have significantly higher baseline urinary protein-to-creatinine ratios than the placebo groups' mean values. Triglycerides were significantly lowered by the fish oil.
[Study title: Multicenter, Placebo-Controlled Trial of Alternate-Day Prednisone (QOD-PRED) or Daily Omega-3 Fatty Acids (OM-3 FA) in Children and Young Adults With IgA Nephropathy (IGAN). Report From the Southwest Pediatric Nephrology Study Group. Abstract SU-PO979]
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