Effect of telmisartan on renal outcomes: a randomized trial.
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.
Mann
Johannes F E
JF
Schwabing General Hospital, KfH Kidney Center, Ludwig Maximilians University, Munich, Germany.
Schmieder
Roland E
RE
Dyal
Leanne
L
McQueen
Matthew J
MJ
Schumacher
Helmut
H
Pogue
Janice
J
Wang
Xingyu
X
Probstfield
Jeffrey L
JL
Avezum
Alvaro
A
Cardona-Munoz
Ernesto
E
Dagenais
Gilles R
GR
Diaz
Rafael
R
Fodor
George
G
Maillon
Jean M
JM
Rydén
Lars
L
Yu
Cheuk M
CM
Teo
Koon K
KK
Yusuf
Salim
S
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
D047228:Angiotensin II Type 1 Receptor Blockers; D001562:Benzimidazoles; D001565:Benzoates; D003404:Creatinine; D000077333:Telmisartan