title: Effect of telmisartan on renal outcomes: a randomized trial.
abstract: BACKGROUND
  Angiotensin-receptor blockers (ARBs) blunt progression of advanced diabetic nephropathy, but their long-term renal effects in other patients are not clear.
  
  
  OBJECTIVE
  To examine the long-term renal effects of telmisartan versus placebo in adults at high vascular risk.
  
  
  METHODS
  Randomized trial. Patients were randomly assigned by a central automated system between November 2001 and May 2004 and were followed until March 2008. Participants and investigators were blinded to intervention status.
  
  
  METHODS
  Multicenter, multinational study.
  
  
  METHODS
  5927 adults with known cardiovascular disease or diabetes with end-organ damage but without macroalbuminuria or heart failure who cannot tolerate angiotensin-converting enzyme inhibitors.
  
  
  METHODS
  Telmisartan, 80 mg/d (n = 2954), or matching placebo (n = 2972) plus standard treatment for a mean of 56 months.
  
  
  METHODS
  Composite renal outcome of dialysis or doubling of serum creatinine, changes in estimated glomerular filtration rate (GFR), and changes in albuminuria.
  
  
  RESULTS
  No important difference was found in the composite renal outcome with telmisartan (58 patients [1.96%]) versus placebo (46 patients [1.55%]) (hazard ratio, 1.29 [95% CI, 0.87 to 1.89]; P = 0.20). Among the telmisartan and placebo groups, 7 and 10 patients had dialysis and 56 and 36 patients had doubling of serum creatinine, respectively (hazard ratio, 1.59 [CI, 1.04 to 2.41]; P = 0.031). Albuminuria increased less with telmisartan than with placebo (32% [CI, 23% to 41%] vs. 63% [CI, 52% to 76%]; P < 0.001). Decreases in estimated GFR were greater with telmisartan than with placebo (mean change in estimated GFR, -3.2 mL/min per 1.73 m(2) [SD, 18.3] vs. -0.26 mL/min per 1.73 m(2) [SD, 18.0]; P < 0.001).
  
  
  CONCLUSIONS
  Only 17 participants had dialysis.
  
  
  CONCLUSIONS
  In adults with vascular disease but without macroalbuminuria, the effects of telmisartan on major renal outcomes were similar to those of placebo.
authors.affiliation: Schwabing General Hospital, KfH Kidney Center, Ludwig Maximilians University, Munich, Germany.
authors.forename: Johannes F E
authors.initials: JF
authors.lastname: Mann
authors.forename: Roland E
authors.initials: RE
authors.lastname: Schmieder
authors.forename: Leanne
authors.initials: L
authors.lastname: Dyal
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: McQueen
authors.forename: Helmut
authors.initials: H
authors.lastname: Schumacher
authors.forename: Janice
authors.initials: J
authors.lastname: Pogue
authors.forename: Xingyu
authors.initials: X
authors.lastname: Wang
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Probstfield
authors.forename: Alvaro
authors.initials: A
authors.lastname: Avezum
authors.forename: Ernesto
authors.initials: E
authors.lastname: Cardona-Munoz
authors.forename: Gilles R
authors.initials: GR
authors.lastname: Dagenais
authors.forename: Rafael
authors.initials: R
authors.lastname: Diaz
authors.forename: George
authors.initials: G
authors.lastname: Fodor
authors.forename: Jean M
authors.initials: JM
authors.lastname: Maillon
authors.forename: Lars
authors.initials: L
authors.lastname: Rydén
authors.forename: Cheuk M
authors.initials: CM
authors.lastname: Yu
authors.forename: Koon K
authors.initials: KK
authors.lastname: Teo
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
mesh_terms: D000368:Aged; D000419:Albuminuria / Q000209:etiology / Q000517:prevention & control; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use*; D001565:Benzoates / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000150:complications*; D003404:Creatinine / Q000097:blood; D003928:Diabetic Nephropathies / Q000503:physiopathology / Q000517:prevention & control*; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007674:Kidney Diseases / Q000503:physiopathology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D000077333:Telmisartan
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D001562:Benzimidazoles; D001565:Benzoates; D003404:Creatinine; D000077333:Telmisartan