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Questions {❓}

• Chudleigh RA, Dunseath G, Evans W et al (2007) How reliable is estimation of glomerular filtration rate at diagnosis of type 2 diabetes?
• Heerspink HL, de Zeeuw D (2010) Composite renal endpoints: was ACCOMPLISH accomplished?
• Is this a cause for concern?

Schema {🗺️}

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         headline:Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study
         description: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. 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. 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−1 1.73 m−2 (95% CI 2.3–7.7, p < 0.001). 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 9–18]; p < 0.001), with 14% less progression and 18% more albuminuria regression (p < 0.001) than in participants on placebo. End-stage renal event frequency was similar (n = 21 vs 26, p = 0.48). Fenofibrate reduced albuminuria and slowed estimated GFR loss over 5 years, despite initially and reversibly increasing plasma creatinine. Fenofibrate may delay albuminuria and GFR impairment in type 2 diabetes patients. Confirmatory studies are merited. ISRCTN64783481 The study was funded by grants from Laboratoires Fournier SA (Dijon, France; now part of Abbott Pharmaceuticals) and the National Health and Medical Research Council, Australia
         datePublished:2010-11-04T00:00:00Z
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            Creatinine
            Diabetes
            Fenofibrate
            FIELD
            GFR
            Nephropathy
            Renal impairment
            Internal Medicine
            Metabolic Diseases
            Human Physiology
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      headline:Effects of fenofibrate on renal function in patients with type 2 diabetes mellitus: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study
      description: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. 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. 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−1 1.73 m−2 (95% CI 2.3–7.7, p < 0.001). 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 9–18]; p < 0.001), with 14% less progression and 18% more albuminuria regression (p < 0.001) than in participants on placebo. End-stage renal event frequency was similar (n = 21 vs 26, p = 0.48). Fenofibrate reduced albuminuria and slowed estimated GFR loss over 5 years, despite initially and reversibly increasing plasma creatinine. Fenofibrate may delay albuminuria and GFR impairment in type 2 diabetes patients. Confirmatory studies are merited. ISRCTN64783481 The study was funded by grants from Laboratoires Fournier SA (Dijon, France; now part of Abbott Pharmaceuticals) and the National Health and Medical Research Council, Australia
      datePublished:2010-11-04T00:00:00Z
      dateModified:2010-11-04T00:00:00Z
      pageStart:280
      pageEnd:290
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      keywords:
         Albuminuria
         Creatinine
         Diabetes
         Fenofibrate
         FIELD
         GFR
         Nephropathy
         Renal impairment
         Internal Medicine
         Metabolic Diseases
         Human Physiology
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      name:R. Ting
      affiliation:
            name:The FIELD Study, c/o NHMRC Clinical Trials Centre
            address:
               name:The FIELD Study, c/o NHMRC Clinical Trials Centre, University of Sydney, Australia
               type:PostalAddress
            type:Organization
            name:Royal Prince Alfred Hospital
            address:
               name:Royal Prince Alfred Hospital, Sydney, Australia
               type:PostalAddress
            type:Organization
      email:[email protected]
      name:J. D. Best
      affiliation:
            name:University of Melbourne
            address:
               name:Department of Medicine, St Vincent’s Hospital, University of Melbourne, Melbourne, Australia
               type:PostalAddress
            type:Organization
      name:M. W. Donoghoe
      affiliation:
            name:The FIELD Study, c/o NHMRC Clinical Trials Centre
            address:
               name:The FIELD Study, c/o NHMRC Clinical Trials Centre, University of Sydney, Australia
               type:PostalAddress
            type:Organization
      name:P. L. Drury
      affiliation:
            name:Greenlane Clinical Centre
            address:
               name:Auckland Diabetes Centre, Greenlane Clinical Centre, Auckland, New Zealand
               type:PostalAddress
            type:Organization
      name:D. R. Sullivan
      affiliation:
            name:Royal Prince Alfred Hospital
            address:
               name:Royal Prince Alfred Hospital, Sydney, Australia
               type:PostalAddress
            type:Organization
      name:A. J. Jenkins
      affiliation:
            name:University of Melbourne
            address:
               name:Department of Medicine, St Vincent’s Hospital, University of Melbourne, Melbourne, Australia
               type:PostalAddress
            type:Organization
      name:R. L. O’Connell
      affiliation:
            name:The FIELD Study, c/o NHMRC Clinical Trials Centre
            address:
               name:The FIELD Study, c/o NHMRC Clinical Trials Centre, University of Sydney, Australia
               type:PostalAddress
            type:Organization
      name:M. J. Whiting
      affiliation:
            name:Flinders Medical Centre
            address:
               name:Flinders Medical Centre, Adelaide, Australia
               type:PostalAddress
            type:Organization
      name:P. P. Glasziou
      affiliation:
            name:University of Oxford
            address:
               name:Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK
               type:PostalAddress
            type:Organization
      name:R. J. Simes
      affiliation:
            name:The FIELD Study, c/o NHMRC Clinical Trials Centre
            address:
               name:The FIELD Study, c/o NHMRC Clinical Trials Centre, University of Sydney, Australia
               type:PostalAddress
            type:Organization
      name:Y. A. Kesäniemi
      affiliation:
            name:University of Oulu
            address:
               name:Institute of Clinical Medicine, Department of Internal Medicine, University of Oulu, Oulu, Finland
               type:PostalAddress
            type:Organization
            name:University of Oulu
            address:
               name:Biocenter Oulu, University of Oulu, Oulu, Finland
               type:PostalAddress
            type:Organization
            name:Oulu University Hospital
            address:
               name:Clinical Research Centre, Oulu University Hospital, Oulu, Finland
               type:PostalAddress
            type:Organization
      name:V. J. Gebski
      affiliation:
            name:The FIELD Study, c/o NHMRC Clinical Trials Centre
            address:
               name:The FIELD Study, c/o NHMRC Clinical Trials Centre, University of Sydney, Australia
               type:PostalAddress
            type:Organization
      name:R. S. Scott
      affiliation:
            name:Christchurch Hospital
            address:
               name:Lipid & Diabetes Research Group, Christchurch Hospital, Christchurch, New Zealand
               type:PostalAddress
            type:Organization
      name:A. C. Keech
      affiliation:
            name:The FIELD Study, c/o NHMRC Clinical Trials Centre
            address:
               name:The FIELD Study, c/o NHMRC Clinical Trials Centre, University of Sydney, Australia
               type:PostalAddress
            type:Organization
            name:Royal Prince Alfred Hospital
            address:
               name:Royal Prince Alfred Hospital, Sydney, Australia
               type:PostalAddress
            type:Organization
      email:[email protected]
PostalAddress:
      name:School of Medicine and Pharmacology, Fremantle Hospital, University of Western Australia, Fremantle, Australia
      name:The FIELD Study, c/o NHMRC Clinical Trials Centre, University of Sydney, Australia
      name:Royal Prince Alfred Hospital, Sydney, Australia
      name:Department of Medicine, St Vincent’s Hospital, University of Melbourne, Melbourne, Australia
      name:The FIELD Study, c/o NHMRC Clinical Trials Centre, University of Sydney, Australia
      name:Auckland Diabetes Centre, Greenlane Clinical Centre, Auckland, New Zealand
      name:Royal Prince Alfred Hospital, Sydney, Australia
      name:Department of Medicine, St Vincent’s Hospital, University of Melbourne, Melbourne, Australia
      name:The FIELD Study, c/o NHMRC Clinical Trials Centre, University of Sydney, Australia
      name:Flinders Medical Centre, Adelaide, Australia
      name:Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK
      name:The FIELD Study, c/o NHMRC Clinical Trials Centre, University of Sydney, Australia
      name:Institute of Clinical Medicine, Department of Internal Medicine, University of Oulu, Oulu, Finland
      name:Biocenter Oulu, University of Oulu, Oulu, Finland
      name:Clinical Research Centre, Oulu University Hospital, Oulu, Finland
      name:The FIELD Study, c/o NHMRC Clinical Trials Centre, University of Sydney, Australia
      name:Lipid & Diabetes Research Group, Christchurch Hospital, Christchurch, New Zealand
      name:The FIELD Study, c/o NHMRC Clinical Trials Centre, University of Sydney, Australia
      name:Royal Prince Alfred Hospital, Sydney, Australia

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