Effect of Fenofibrate on Kidney Function: A 6-Week Randomized Crossover Trial in Healthy People

Ansquer, Jean-Claude; Dalton, R. Neil; Caussé, Elizabeth; Crimet, Dominique; Malicot, Karine Le; Foucher, Christelle

doi:10.1053/j.ajkd.2008.01.014

Cited by 88 publications

(97 citation statements)

References 44 publications

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“…Greater preservation of estimated GFR with fenofibrate was observed with baseline hypertriacylglycerolaemia (n=169 vs 491 without) alone, or combined with low HDL-cholesterol (n=140 vs 520 without) and reductions of ≥0.48 mmol/l in triacylglycerol over the active run-in period (pre-randomisation) (n=356 vs 303 without). Fenofibrate reduced urine albumin concentrations and hence albumin/creatinine ratio by 24% vs 11% (p<0.001; mean difference 14% [95% CI [9][10][11][12][13][14][15][16][17][18]; p<0.001), with 14% less progression and 18% more albuminuria regression (p<0.001) than in participants on placebo. Endstage renal event frequency was similar (n=21 vs 26, p=0.48).…”

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confidence: 99%

Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study

et al. 2010

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Aims/hypothesis Fenofibrate caused an acute, sustained plasma creatinine increase in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and Action to Control Cardiovascular Risk in Diabetes (ACCORD) studies. We assessed fenofibrate's renal effects overall and in a FIELD washout sub-study. Methods Type 2 diabetic patients (n=9,795) aged 50 to 75 years were randomly assigned to fenofibrate (n=4,895) or placebo (n=4,900) for 5 years, after 6 weeks fenofibrate run-in. Albuminuria (urinary albumin/creatinine ratio measured at baseline, year 2 and close-out) and estimated GFR, measured four to six monthly according to the Modification of Diet in Renal Disease Study, were pre-specified endpoints. Plasma creatinine was re-measured 8 weeks after treatment cessation at close-out (washout sub-study, n=661). Analysis was by intention-to-treat. Results During fenofibrate run-in, plasma creatinine increased by 10.0 μmol/l (p<0.001), but quickly reversed on placebo assignment. It remained higher on fenofibrate than on placebo, but the chronic rise was slower (1.62 vs 1.89 μmol/l annually, p=0.01), with less estimated GFR loss (1.19 vs 2.03 ml min −1 1.73 m −2 annually, p<0.001). After washout, estimated GFR had fallen less from baseline on fenofibrate (1.9 ml min −1 1.73 m −2 , p=0.065) than on placebo (6.9 ml min −1 1.73 m −2 , p<0.001), sparing 5.0 ml min

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confidence: 99%

Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study

et al. 2010

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“…There is no evidence that fibrates (and their metabolites) which are organic anions affect renal tubular secretion of creatinine [26]. In fact a rise in urinary creatinine levels have been observed in patients experiencing hypercreatininaemia following fibrate therapy [9,10]. Several studies which have measured GFR in patients with creatinine elevation (up to a 20% increase) following fibrate treatment have not demonstrated glomerular impairment using inulin [8][9][10].…”

Section: Discussionmentioning

confidence: 99%

“…In fact a rise in urinary creatinine levels have been observed in patients experiencing hypercreatininaemia following fibrate therapy [9,10]. Several studies which have measured GFR in patients with creatinine elevation (up to a 20% increase) following fibrate treatment have not demonstrated glomerular impairment using inulin [8][9][10]. Significant direct nephrotoxicity induced by fibrates within the commonly observed range of creatinine increase is unlikely as no increase in proteinuria has previously been reported with these drugs; in fact a reduction in the rate of onset and progression of microalbuminuria has been described [27].…”

Section: Discussionmentioning

confidence: 99%

“…Both studies showed that elevation of creatinine was real and not method dependant. Hottelart et al [10] in a subsequent study and Ansquer et al [9] concluded that an increased metabolic production rate was the most likely cause of the raised creatinine observed as urinary levels of creatinine were not reduced and GFR measured by inulin was not impaired. Davidson et al also agreed in a review of the safety profile of fibrate therapy that the increase in creatinine observed did not represent a true deterioration in renal function [11].…”

Section: Introductionmentioning

confidence: 93%

“…They and Ansquer et al [9] investigated whether the hypercreatininemia was due to an analytical interference by comparing the Jaffe colorimetric method with HPLC and mass spectrometry. Both studies showed that elevation of creatinine was real and not method dependant.…”

Section: Introductionmentioning

confidence: 99%

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Factors Associated With Fibrate-Induced Creatinine Elevation: Observations in an Outpatient Setting

Аббас

2012

World J Nephrol Urol

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Efficacy and safety of fenofibrate addition therapy in patients with cirrhotic primary biliary cholangitis with incomplete response to ursodeoxycholic acid

et al. 2022

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Fenofibrate (FF) has shown potential benefits in patients with primary biliary cholangitis (PBC) who have an incomplete response to ursodeoxycholic acid (UDCA). However, the efficacy and safety of FF in patients with cirrhosis remain unclear. To evaluate the efficacy and safety of additional FF therapy in patients with PBC‐related cirrhosis with an incomplete response to UDCA, we conducted a retrospective analysis comparing the clinical results of additional FF therapy and continued UDCA monotherapy. A total of 59 patients were included; 27 cases underwent UDCA monotherapy and 32 cases underwent UDCA combined with FF therapy. A significant difference in alkaline phosphatase (ALP) normalization was achieved in the FF group compared to the UDCA group (37% vs. 11%, respectively; p = 0.020). Additional FF therapy was an independent risk factor for ALP normalization (hazard ratio, 7.679; 95% confidence interval, 2.059–28.633; p = 0.003). Hepatic deterioration was experienced by 40% versus 48% (p = 0.562) while 11% vs. 37% (p = 0.111) experienced liver‐related mortality or liver transplantation in the FF and UDCA groups, respectively. Compared to UDCA monotherapy, additional FF therapy was associated with lower United Kingdom (UK)‐PBC risk score and surrogate serum indices of liver fibrosis. After 12 months of add‐on FF therapy, median ALP level and UK‐PBC risk score decreased 35% and 52% from baseline (p = 0.001 and 0.210, respectively). Serum aminotransferase, triglyceride, and cholesterol decreased progressively, while total bilirubin, serum creatinine, blood urea, estimated glomerular filtration rate, aspartate aminotransferase‐to‐platelet ratio index, and fibrosis‐4 index remained stable in FF‐treated cirrhotic cases during follow‐up. No significant adverse effects associated with additional FF therapy were observed in our cohort. Conclusion: Additional FF therapy was associated with higher ALP normalization rates and lower UK‐PBC risk scores in patients with cirrhotic PBC with an incomplete response to UDCA. In addition, FF therapy seemed safe and well tolerated with a low frequency of adverse effects in patients with cirrhosis.

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Effect of Fenofibrate on Kidney Function: A 6-Week Randomized Crossover Trial in Healthy People

Cited by 88 publications

References 44 publications

Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study

Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study

Factors Associated With Fibrate-Induced Creatinine Elevation: Observations in an Outpatient Setting

Efficacy and safety of fenofibrate addition therapy in patients with cirrhotic primary biliary cholangitis with incomplete response to ursodeoxycholic acid

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