title: Efficacy and Safety of Complete RAAS Blockade with ALISKIREN in Patients with Refractory Proteinuria Who were already on Combined ACE Inhibitor, ARB, and Aldosterone Antagonist.
abstract: BACKGROUND
  Proteinuria is always associated with intrinsic kidney disese and is a strong predictor of later development of End Stage Renal Disease (ESRD). As Renin Angiotensin Aldosterone System (RAAS) has a role in mediating proteinuria, inhibitors of this system are renoprotective and patients with refractory proteinuria are put on a combination of these agents. The routinely employed triple blockade of RAAS with Angiotensin Converting Enzyme (ACE) inhibitor, ARB and Aldosterone antagonist has many limitations. Addition of Aliskiren to this combination suppresses the RAAS at the earliest stage and can offset many of these limitations.
  
  
  OBJECTIVE
  This study was conducted to assess the safety and efficacy of complete RAAS blockade by the addition of Aliskiren in those patients with refractory proteinuria who were already on triple blockade with ACE inhibitor, ARB and Aldosterone antagonist.
  
  
  METHODS
  This study was conducted in Nephrology Department, Calicut Medical College.
  
  
  METHODS
  A total of 36 patients with refractory proteinuria who were already on ACE inhibitor, ARB and Aldosterone antagonist were divided in to two groups A and B. Group A received Aliskiren in addition to the above combination whereas group B continued the same treatment for 12 weeks. Efficacy of the treatment was assessed by recording 24hr urine protein and safety by S.Creatinine, S.Potassium every 2 weeks of the treatment period.
  
  
  METHODS
  Statistical analysis of the lab values was done using SPSS software. Unpaired t-test, Paired t-test and Chi-square test were done for data analysis.
  
  
  RESULTS
  Statistical analysis revealed that addition of Aliskiren to the combination therapy with ACE inhibitor+ ARB+ Aldosterone antagonist offers no advantage. But mean reduction in proteinuria was more with Group A than Group B. There is no statistically significant change in S.Creatinine and S.Potassium at the end of treatment.
  
  
  CONCLUSIONS
  As proteinuria is a strong risk factor for progression to ESRD, even a mild decrease in proteinuria by treatment is renoprotective. Hence treatment with group A may be considered clinically superior to group B with no alteration in safety and tolerability. But further multicentre studies with larger sample size and dose escalation are required for confirmation.
authors: Assistant Professor, Department of Pharmacology, Government Medical College , Kottayam, Kerela, India .
authors: Prabitha
authors: P
authors: Panattil
authors: Professor and Head of Department, Department of Nephrology, Government Medical College , Calicut, Kerela, India .
authors: M
authors: M
authors: Sreelatha
keywords: Direct renin inhibitor; End stage renal disease; Nephrotic syndrome