Clinical effectiveness

For the monitoring of the stage progression and therapeutic effects of diabetes nephropathy

Key word: Diabetic Nephropathy

Clinical significance of diabetic nephropathy

With respect to diabetic nephropathy, it was confirmed after a cross-sectional analysis of type 1 diabetes at the Steno Diabetes Center of Denmark that urinary L-FABP significantly rises at a stage earlier than microalbuminuria.

Furthermore, in an inspection of the prognostic diagnosis performance of urinary L-FABP before nephropathy progression targeting patients who had undergone prognostic observation for roughly 30 years from disease onset, it became clear that, surprisingly, even in early-stage nephropathy, the patient group with high urinary L-FABP values had significantly high values during the 20+ year follow-up period for both microalbuminuria and risk of death.

Also, in a 4-year prospective clinical trial targeting outpatients with type 2 diabetes in Japan, it became clear that, of the patients who were CKD stage I or stage II, compared to microalbuminuria patients, positive patients for whom the normal upper limit was the cut-off for urinary L-FABP had a significantly high risk of diabetic nephropathy stage progression over the following 4 years.

Diabetic Nephropathy Progression Curve (Kaplan-Meier curve) by Urinary L-FABP Values

In a clinical study of diabetic nephropathy targeting type 1 diabetes and type 2 diabetes, urinary L-FABP increased with diabetes stage progression, and also had significantly high values compared to the normal control in the earlier stages of nephropathy, when trace amounts of albumin in the urine cannot be found[1],[2].

In a longitudinal study targeting patients (n=165) with type 1 diabetes and in the earlier stages of nephropathy, it was found that there was significant progression to early-stage nephropathy by the patient group with high urinary L-FABP values compared to the patient group with low urinary L-FABP values (figure on right)[3].

Furthermore, it has been found that urinary L-FABP is important as a risk factor in the progression of type II diabetic nephropathy[4].

References

  • [1] Nakamura, T. et al., Effect of Pitavastatin on Urinary Liver-Type Fatty Acid–Binding Protein Levels in Patients With Early Diabetic Nephropathy. Diabetes Care. 28(11): 2728-2732, 2005. PubMed
  • [2] Nielsen, S.E. et al., Tubular and glomerular injury in diabetes and the impact of ACE inhibition. Diabetes Care. 32(9): 1684-1688, 2009. PubMed
  • [3] Nielsen, S.E. et al., Urinary liver-type fatty acid-binding protein predicts progression to nephropathy in type 1 diabetic patients. Diabetes Care. 33(6): 1320-1324, 2010. PubMed
  • [4] Kamijo-Ikemori, A. et al., Clinical significance of urinary liver-type fatty acid-binding protein in diabetic nephropathy of type 2 diabetic patients. Diabetes Care. 34(3): 691-696, 2011. PubMed

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For nonclinical safety evaluation

Urinary L-FABP kits for Rat, Dog, Cat, Monkey and Pig are available for the purpose of monitoring drug nephrotoxicity and drug effectiveness.
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