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Renal outcomes with aliskiren in patients with type 2 diabetes: a prespecified secondary analysis of the ALTITUDE randomised controlled trial.

Abstract The primary results of the ALTITUDE trial showed no benefit of aliskiren on renal outcomes (doubling of serum creatinine and end-stage renal disease) when used as an adjunct to angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) in patients with type 2 diabetes and chronic kidney disease or cardiovascular disease. We did a prespecified analysis of the ALTITUDE trial to analyse the effects of aliskiren on surrogate renal outcomes in all patients and on primary renal outcomes in subgroups of patients.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title the lancet. diabetes & endocrinology
Publication Year Start




PMID- 26774608
OWN - NLM
STAT- MEDLINE
DA  - 20160326
DCOM- 20170112
LR  - 20170113
IS  - 2213-8595 (Electronic)
IS  - 2213-8587 (Linking)
VI  - 4
IP  - 4
DP  - 2016 Apr
TI  - Renal outcomes with aliskiren in patients with type 2 diabetes: a prespecified
      secondary analysis of the ALTITUDE randomised controlled trial.
PG  - 309-17
LID - 10.1016/S2213-8587(15)00469-6 [doi]
LID - S2213-8587(15)00469-6 [pii]
AB  - BACKGROUND: The primary results of the ALTITUDE trial showed no benefit of
      aliskiren on renal outcomes (doubling of serum creatinine and end-stage renal
      disease) when used as an adjunct to angiotensin-converting enzyme (ACE)
      inhibitors or angiotensin receptor blockers (ARBs) in patients with type 2
      diabetes and chronic kidney disease or cardiovascular disease. We did a
      prespecified analysis of the ALTITUDE trial to analyse the effects of aliskiren
      on surrogate renal outcomes in all patients and on primary renal outcomes in
      subgroups of patients. METHODS: In the double-blind, randomised, controlled
      ALTITUDE trial, 8561 patients with type 2 diabetes and chronic kidney disease or 
      cardiovascular disease were randomly assigned (1:1) to receive aliskiren 300 mg
      per day or placebo as an adjunct to ACE inhibitors or ARBs. Randomisation was
      stratified on the basis of baseline urinary albumin-to-creatinine ratio and
      presence of cardiovascular disease history, and treatment assignments were masked
      to all patients and study staff. Patients were followed up for a median of 2.6
      years (IQR 2.0-3.2). In our secondary analysis, we investigated prespecified
      intermediate renal outcomes of transitions in albuminuria stages (ie, transitions
      between normoalbuminuria, microalbuminuria, and macroalbuminuria) and rate of
      change of estimated glomerular filtration rate (eGFR). We investigated all
      outcomes in the intention-to-treat population. The primary composite renal
      outcome of ALTITUDE was defined as a sustained doubling of serum creatinine,
      end-stage renal disease, or renal death. The ALTITUDE trial is registered with
      ClinicalTrials.gov, number NCT00549757. FINDINGS: Aliskiren significantly
      decreased progression (hazard ratio [HR] 0.83, 95% CI 0.75-0.93) and increased
      regression (HR 1.29, 95% CI 1.19-1.39) of transitions in albuminuria classes. The
      annual rate of change of eGFR was -3.1 mL/min/1.73 m(2) per year (95% CI -2.9 to 
      -3.3) in the aliskiren group and -3.0 mL/min/1.73 m(2) per year (-2.8 to -3.2) in
      the placebo group (p=0.52). eGFR change during the first 6 months was
      significantly larger with aliskiren than with placebo (-2.5 mL/min/1.73 m(2), 95%
      CI -2.9 to -2.2 vs -1.4 mL/min/1.73 m(2), 95% CI -1.7 to -1.0; p<0.0001).
      Subsequent eGFR change did not differ significantly between groups (-2.8
      mL/min/1.73 m(2) per year, 95% CI -3.0 to -2.6 with aliskiren vs -3.1 mL/min/1.73
      m(2) per year, 95% CI -3.3 to -2.8 with placebo; p=0.068). The absence of a
      benefit of aliskiren on the primary composite renal endpoint in the overall
      population was also seen in various subgroups. INTERPRETATION: Aliskiren showed
      no beneficial effect on hard renal outcomes in the overall population or in
      various subgroups, but delayed progression to microalbuminuria and
      macroalbuminuria, and improved regression to microalbuminuria and
      normoalbuminuria. Whether the chosen intermediates are poor surrogates for
      clinical outcomes or whether off-target effects disrupt the association between
      the surrogate and clinical outcomes requires further study. FUNDING: Novartis.
CI  - Copyright (c) 2016 Elsevier Ltd. All rights reserved.
FAU - Heerspink, Hiddo J L
AU  - Heerspink HJ
AD  - Department of Clinical Pharmacy and Pharmacology, University of Groningen,
      University Medical Center Groningen, Groningen, Netherlands. Electronic address: 
      [email protected]
FAU - Persson, Frederik
AU  - Persson F
AD  - Steno Diabetes Center, Gentofte, Denmark.
FAU - Brenner, Barry M
AU  - Brenner BM
AD  - Renal Division, Brigham and Women's Hospital and Harvard Medical School, Boston, 
      MA, USA.
FAU - Chaturvedi, Nish
AU  - Chaturvedi N
AD  - Institute of Cardiovascular Sciences, University College London, London, UK.
FAU - Brunel, Patrick
AU  - Brunel P
AD  - Global Medical Affairs, Novartis, Basel, Switzerland.
FAU - McMurray, John J
AU  - McMurray JJ
AD  - BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
FAU - Desai, Akshay S
AU  - Desai AS
AD  - Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School,
      Boston, MA, USA.
FAU - Solomon, Scott D
AU  - Solomon SD
AD  - Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School,
      Boston, MA, USA.
FAU - Pfeffer, Marc A
AU  - Pfeffer MA
AD  - Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School,
      Boston, MA, USA.
FAU - Parving, Hans-Henrik
AU  - Parving HH
AD  - Department of Medical Endocrinology, Rigshospitalet, University of Copenhagen,
      Copenhagen, Denmark.
FAU - de Zeeuw, Dick
AU  - de Zeeuw D
AD  - Department of Clinical Pharmacy and Pharmacology, University of Groningen,
      University Medical Center Groningen, Groningen, Netherlands.
LA  - eng
SI  - ClinicalTrials.gov/NCT00549757
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160114
PL  - England
TA  - Lancet Diabetes Endocrinol
JT  - The lancet. Diabetes & endocrinology
JID - 101618821
RN  - 0 (Amides)
RN  - 0 (Angiotensin Receptor Antagonists)
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Fumarates)
RN  - 502FWN4Q32 (aliskiren)
RN  - AYI8EX34EU (Creatinine)
SB  - IM
CIN - Lancet Diabetes Endocrinol. 2016 Apr;4(4):289-90. PMID: 26774607
MH  - Aged
MH  - Albuminuria/chemically induced/*epidemiology
MH  - Amides/*adverse effects
MH  - Angiotensin Receptor Antagonists
MH  - Antihypertensive Agents
MH  - Creatinine/urine
MH  - Diabetes Mellitus, Type 2/complications/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Fumarates/*adverse effects
MH  - Glomerular Filtration Rate
MH  - Humans
MH  - Kidney Failure, Chronic/chemically induced/*epidemiology
MH  - Male
MH  - Netherlands/epidemiology
MH  - Prevalence
MH  - Prognosis
MH  - Survival Rate
EDAT- 2016/01/18 06:00
MHDA- 2017/01/14 06:00
CRDT- 2016/01/18 06:00
PHST- 2015/09/28 [received]
PHST- 2015/10/30 [revised]
PHST- 2015/11/23 [accepted]
AID - S2213-8587(15)00469-6 [pii]
AID - 10.1016/S2213-8587(15)00469-6 [doi]
PST - ppublish
SO  - Lancet Diabetes Endocrinol. 2016 Apr;4(4):309-17. doi:
      10.1016/S2213-8587(15)00469-6. Epub 2016 Jan 14.

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