title: Effect of pentoxifylline on renal function and urinary albumin excretion in patients with diabetic kidney disease: the PREDIAN trial.
abstract: Diabetic kidney disease (DKD) is the leading cause of ESRD. We conducted an open-label, prospective, randomized trial to determine whether pentoxifylline (PTF), which reduces albuminuria, in addition to renin-angiotensin system (RAS) blockade, can slow progression of renal disease in patients with type 2 diabetes and stages 3-4 CKD. Participants were assigned to receive PTF (1200 mg/d) (n=82) or to a control group (n=87) for 2 years. All patients received similar doses of RAS inhibitors. At study end, eGFR had decreased by a mean±SEM of 2.1±0.4 ml/min per 1.73 m(2) in the PTF group compared with 6.5±0.4 ml/min per 1.73 m(2) in the control group, with a between-group difference of 4.3 ml/min per 1.73 m(2) (95% confidence interval [95% CI], 3.1 to 5.5 ml/min per 1.73 m(2); P<0.001) in favor of PTF. The proportion of patients with a rate of eGFR decline greater than the median rate of decline (0.16 ml/min per 1.73 m(2) per month) was lower in the PTF group than in the control group (33.3% versus 68.2%; P<0.001). Percentage change in urinary albumin excretion was 5.7% (95% CI, -0.3% to 11.1%) in the control group and -14.9% (95% CI, -20.4% to -9.4%) in the PTF group (P=0.001). Urine TNF-α decreased from a median 16 ng/g (interquartile range, 11-20.1 ng/g) to 14.3 ng/g (interquartile range, 9.2-18.4 ng/g) in the PTF group (P<0.01), with no changes in the control group. In this population, addition of PTF to RAS inhibitors resulted in a smaller decrease in eGFR and a greater reduction of residual albuminuria.
authors: Nephrology Service, Research Unit, GEENDIAB (Spanish Group for the Study of Diabetic Nephropathy), University Hospital Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain jnavgon@gobiernodecanarias.org.
authors: Juan F
authors: JF
authors: Navarro-González
authors: Research Unit, GEENDIAB (Spanish Group for the Study of Diabetic Nephropathy), University Hospital Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain.
authors: Carmen
authors: C
authors: Mora-Fernández
authors: GEENDIAB (Spanish Group for the Study of Diabetic Nephropathy), University Hospital Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain Clinical Analysis Service, and.
authors: Mercedes
authors: M
authors: Muros de Fuentes
authors: Nephrology Service.
authors: Jesús
authors: J
authors: Chahin
authors: Nephrology Service.
authors: María L
authors: ML
authors: Méndez
authors: Nephrology Service.
authors: Eduardo
authors: E
authors: Gallego
authors: Nephrology Service.
authors: Manuel
authors: M
authors: Macía
authors: Nephrology Service.
authors: Nieves
authors: N
authors: del Castillo
authors: Nephrology Service.
authors: Antonio
authors: A
authors: Rivero
authors: Nephrology Service.
authors: María A
authors: MA
authors: Getino
authors: Nephrology Service.
authors: Patricia
authors: P
authors: García
authors: Nephrology Service.
authors: Ana
authors: A
authors: Jarque
authors: Nephrology Service.
authors: Javier
authors: J
authors: García
mesh_terms: D000368:Aged; D000418:Albumins / Q000032:analysis*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003928:Diabetic Nephropathies / Q000188:drug therapy* / Q000652:urine*; D018450:Disease Progression; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D007249:Inflammation; D007668:Kidney / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D010431:Pentoxifylline / Q000627:therapeutic use*; D011446:Prospective Studies; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D000418:Albumins; D010431:Pentoxifylline
keywords: albuminuria; chronic kidney disease; diabetic nephropathy; inflammation; progression of chronic renal failure