El efecto de la pentoxifilina en la reducción de proteinuria en pacientes con diabetes tipo 2 con bloqueo del sistema de angiotensina: ensayo clínico doble ciego y aleatorizado

Ghorbani, Ali; Ghorbani, Ali; Omidvar, Bita; Omidvar, Bita; Beladi-Mousavi, Seyed S.; Beladi Mousavi, Seyed Seifollah; Lak, Elena; Lak, Elena; Vaziri, Sima; Vaziri, Sima

doi:10.3265/Nefrologia.pre2012.Jun.11242

Article information

Aunque el bloqueo del sistema renina-angiotensina ha sido citado como el tratamiento inicial para la nefropatía diabética (ND), en un número significativo de pacientes el avance de la enfermedad renal no se ve frenado en su totalidad por estos agentes. Hemos realizado un ensayo clínico doble ciego para valorar el efecto acumulativo de la pentoxifilina (PTX) en la reducción de la proteinuria en pacientes con diabetes tipo 2 (DM2) con bloqueo del sistema de angiotensina. La dosis de PTX utilizada en nuestro ensayo fue una cantidad baja de 400 mg diarios y, en nuestra experiencia, no logramos encontrar ningún artículo que evaluara el efecto antiproteinúrico de la PTX con esta dosis. De forma aleatoria, se dividieron en dos grupos 100 pacientes con ND y proteinuria persistente a pesar del tratamiento con losartán y enalapril durante al menos tres meses antes de ser incluidos en el estudio. El grupo de control (n = 50, 26 hombres y 24 mujeres) fueron tratados con losartán y enalapril, mientras que el grupo de tratamiento (grupo de PTX: n = 50, 28 hombres y 22 mujeres) recibieron losartán, enalapril y 400 mg/día de pentoxifilina durante 6 meses. Al comienzo del estudio no se encontraron diferencias significativas en las características demográficas y clínicas de los pacientes, incluida la creatinina sérica, HbA1c, presión arterial y excreción urinaria de proteínas entre los dos grupos (p > 0,05). En el grupo de PTX, la tasa media de excreción urinaria de proteína ha disminuido significativamente de 616,66 a 378,24 mg tras 3 meses (p = 0,000) y a 192,05 mg tras 6 meses (p = 0,000), mientras que en el grupo de control no se han observado cambios significativos. El beneficioso efecto antiproteinúrico del PTX no estuvo asociado a la intensidad del cambio metabólico ni a la reducción de la presión arterial. Además, al final del estudio, el aclaramiento medio de creatinina fue significativamente más elevado en el grupo de PTX (p = 0,04). En conclusión, la PTX puede aportar en gran medida un efecto antiproteinúrico acumulativo y ralentizar el grado de filtración glomerular en pacientes con DM2 con bloqueo del sistema de angiotensina.

Palabras clave:

Pentoxifilina

Palabras clave:

Pentoxifilina

Palabras clave:

Nefropatía diabética

Although blockade of renin-angiotensin system have been cited as the first line of therapy for the management of diabetic nephropathy (DN), however in a substantial number of patients, progression of renal disease are not completely halted by these agents. We have conducted a double blinded clinical trial to assess the additive effect of pentoxifylline on reduction of proteinuria among patients with type 2 DM under blockade of angiotensin system. The dosage of PTX used in our trial was at a low dosage of 400mg daily and to our knowledge, we did not found article which evaluated the antiproteinuric effect of pentoxifylline in this dosage. One hundred patients with DN and persistent proteinuria despite treatment with losartan and enalapril in at least 3 months before inclusion in the study were randomly assigned to two groups. Control group (n=50, 26 males and 24 females) received losartan and enalapril, while treatment group (PTX Group) (n=50, 28 males and 22 females) was given losartan, enalapril and pentoxifylline 400mg/day for 6 months. At the beginning of the study there were no significant differences in demographic and clinical characteristics of patients including serum creatinine, HbA1c, blood pressure and urinary protein excretion between two groups (P>.05). In the PTX group, the mean rate of urinary protein excretion have significantly decreased from 616.66mg to 378.24 after 3 months (P=.000) and to 192.05mg after 6 months (P=.000) whereas no significant changes were observed in the control group. The beneficial antiproteinuric effect of PTX was not associated to the degree of metabolic control and a reduction of blood pressure. In addition, at the end of study, the mean clearance of creatinine was significantly higher in PTX group (P=.04). In conclusion, PTX can significantly provide additive antiproteinuric effect and slow the decrease in GFR among patients with type 2 DM under blockade of angiotensin system.

Keywords:

Proteinuria

Keywords:

Pentoxifylline

Keywords:

Diabetic Nephropathy

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