A Randomized Trial of High-Dose Compared with Low-Dose Omega-3 Fatty Acids in Severe IgA Nephropathy
| Autor: | Timothy S. Larson, Erik J. Bergstralh, James V. Donadio, Joseph P. Grande |
|---|---|
| Rok vydání: | 2001 |
| Předmět: |
Adult
Male medicine.medical_specialty Docosahexaenoic Acids Renal function Severity of Illness Index Gastroenterology law.invention Nephropathy Randomized controlled trial law Internal medicine Fatty Acids Omega-3 Clinical endpoint Humans Medicine Prospective Studies Adverse effect Prospective cohort study Aged Dose-Response Relationship Drug business.industry Glomerulonephritis IGA General Medicine Middle Aged medicine.disease Survival Analysis Drug Combinations Treatment Outcome Endocrinology Elevated serum creatinine Eicosapentaenoic Acid Nephrology Creatinine Patient Compliance Female business Kidney disease |
| Zdroj: | Journal of the American Society of Nephrology. 12:791-799 |
| ISSN: | 1046-6673 |
| DOI: | 10.1681/asn.v124791 |
| Popis: | Tested was the hypothesis that high-dose omega (omega)-3 fatty acids will be more effective than low-dose omega-3 fatty acids in preserving renal function in patients with severe IgA nephropathy in a randomized, open-label, parallel-group clinical trial. Patients were assigned to receive either high-dose fatty acids (EPA 3.76 g and DHA 2.94 g) or low-dose fatty acids (EPA 1.88 g and DHA 1.47 g), both given daily in a highly purified ethyl ester concentrate (Omacor). Patients were treated for a minimum of 2 yr in the absence of a treatment failure or until study closure (January 2000). Seventy-three patients were enrolled in the trial with two ranges of elevated serum creatinine (SC): 63 patients (86%) with a range of 1.5 to 2.9 mg/dl and 10 patients (14%) with a range of 3.0 to 4.9 mg/dl. The primary end point, within-patient rates of change in SC (2-yr minimum), showed an annualized median increase in SC of 0.08 mg/dl per yr in the low-dose group and 0.10 mg/dl per yr in the high-dose group (P: = 0.51). Patients in the lower entry SC range had lower SC slopes (P: = 0.02) and less end-stage renal disease (ESRD) (P: < 0.001) compared with those in the higher entry SC range. No patient died, and 18 patients developed ESRD: 10 in the low-dose group and 8 in the high-dose group (P: = 0.56). SC slopes were significantly lower, and survival free of ESRD was significantly higher (both, P: = 0.04) in the 63 Omacor-treated patients compared with the 22 placebo-treated patients from our previously reported clinical trial in which both groups had a similar level of renal impairment. Patient compliance was excellent, and no serious adverse events were noted. Low-dose and high-dose omega-3 fatty acids were similar in slowing the rate of renal function loss in high-risk patients with IgA nephropathy, particularly those with moderately advanced disease. |
| Databáze: | OpenAIRE |
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