Aliskiren y valsartan

Aliskiren Combined with Losartan in Type 2 Diabetes and Nephropathy
Hans-Henrik Parving, M.D., D.M.Sc., Frederik Persson, M.D., Julia B. Lewis, M.D., Edmund J. Lewis, M.D., and Norman K. Hollenberg, M.D., Ph.D., for the AVOID Study Investigators*
Background Diabetic nephropathy is the leading cause of end-stage renal disease in developed countries. We evaluated the renoprotective effects of dual blockade of the renin−angiotensin−aldosterone system by adding treatment with aliskiren, an oral direct renin inhibitor, to treatment with the maximal recommended dose of losartan (100 mg daily) and optimal antihypertensive therapy in patients who had hypertension
and type 2 diabetes with nephropathy.
Methods We enrolled 599 patients in this multinational, randomized, double-blind study. After a 3-month, open-label, run-in period during which patients received 100 mg of losartan daily, patients were randomly assigned to receive 6 months of treatment with aliskiren (150 mg daily for 3 months, followed by an increase in dosage to 300 mg daily for another 3 months) or placebo, in addition to losartan. The primary outcome was a reduction in the ratio of albumin to creatinine, as measured in an earlymorning urine sample, at 6 months.
Results The baseline characteristics of the two groups were similar. Treatment with 300 mg of aliskiren daily, as compared with placebo, reduced the mean urinary albumin-tocreatinine ratio by 20% (95% confidence interval, 9 to 30; P<0.001), with a reduction of 50% or more in 24.7% of the patients who received aliskiren as compared with 12.5% of those who received placebo (P<0.001). A small difference in blood pressure was seen between the treatment groups by the end of the study period (systolic, 2 mm Hg lower [P = 0.07] and diastolic, 1 mm Hg lower [P = 0.08] in the aliskiren group). The total numbers of adverse and serious adverse events were similar in the groups.
Conclusions Aliskiren may have renoprotective effects that are independent of its bloodpressure−lowering effect in patients with hypertension, type 2 diabetes, and nephropathywho are receiving the recommended renoprotective treatment.

Comentario Dra Ana Pastor
COMENTARIOS:

-La proteinuria persistente es el final de la nefropatía diabética, un estado que se caracteriza por el aumento progresivo de la TA, una disminución del filtrado glomerular, y un riesgo elevado de acontecimientos adversos cardiovasculares.
- Este estudio a doble ciego muestra una reducción de albuminuria en grupo control vs placebo, que sigue siendo significativa tras ajustarse a TAS en cada grupo. Es decir, que la reducción de la proteinuria es independiente al efecto antihipertensivo del fármaco y del losartán.
-En este estudio no se incluyeron pacientes con K mayor de 5.1 ni pacientes con filtardo glomerular <30ml/min. Por lo que el efecto sobre el potasio sérico y en pacientes con función renal deprimida no ha sido estudiado.