title: Efficacy of add-on therapy of aliskiren to an angiotensin II receptor blocker on renal outcomes in advanced-stage chronic kidney disease: a prospective, randomized, open-label study.
abstract: BACKGROUND
  Combination therapy of aliskiren and an angiotensin II receptor blocker (ARB) has been reported to be effective for reducing the level of proteinuria. However, it remains unclear whether this combination therapy contributes to suppression of kidney disease progression. The aim of this study was to investigate the effect of aliskiren on hard renal endpoints, when added to an ARB, in patients with advanced chronic kidney disease (CKD).
  
  
  METHODS
  The study design was a prospective, randomized open-label design. 83 CKD patients (52 men and 31 women) were enrolled and assigned randomly to an aliskiren add-on group (n = 42) or control group (n = 41). Entry criteria included elevated serum creatinine ≥ 1.5 mg/dl, urine protein excretion (≥ 1+ on urine dipstick test), and hypertension. All participants were treated with an ARB. The follow-up period was 12 months. 12 participants were withdrawn during the study period and the study was terminated in January 2012 as a consequence of the results of the interim analysis of the ALTITUDE study.
  
  
  RESULTS
  Nine patients in the aliskiren group and seven patients in the control group started dialysis. Doubling of the serum creatinine level occurred in one patient in the control group. A Cox proportional hazards test showed that dual blockade of the renin-angiotensin-aldosterone system with aliskiren and ARB was not associated with improvement in hard renal endpoints.
  
  
  CONCLUSIONS
  We conclude that aliskiren add-on therapy to an ARB may not give any benefit and, therefore, should not be recommended in CKD patients.
authors: Department of Nephrology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
authors: Kotaro
authors: K
authors: Soji
authors: Shigehiro
authors: S
authors: Doi
authors: Ayumu
authors: A
authors: Nakashima
authors: Kensuke
authors: K
authors: Sasaki
authors: Toru
authors: T
authors: Kawai
authors: Asuka
authors: A
authors: Aoki
authors: Yasufumi
authors: Y
authors: Kyuden
authors: Kenta
authors: K
authors: Fujiwara
authors: Yukio
authors: Y
authors: Yokoyama
authors: Takao
authors: T
authors: Masaki
mesh_terms: D000368:Aged; D000577:Amides / Q000494:pharmacology / Q000627:therapeutic use*; D057911:Angiotensin Receptor Antagonists / Q000627:therapeutic use*; D005260:Female; D005650:Fumarates / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007668:Kidney / Q000187:drug effects*; D007676:Kidney Failure, Chronic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D000092502:Renin Inhibitors
chemical_list: D000577:Amides; D057911:Angiotensin Receptor Antagonists; D005650:Fumarates; D000092502:Renin Inhibitors; C446481:aliskiren