Johannes F.E. Mann, MD; Roland E. Schmieder, MD; Leanne Dyal, MSc; Matthew J. McQueen, MD; Helmut Schumacher, MD; Janice Pogue, PhD; Xingyu Wang, PhD; Jeffrey L. Probstfield, MD; Alvaro Avezum, MD, PhD; Ernesto Cardona-Munoz, PhD; Gilles R. Dagenais, MD; Rafael Diaz, MD; George Fodor, MD, PhD; Jean M. Maillon, MD; Lars Rydén, MD; Cheuk M. Yu, MD; Koon K. Teo, MD; Salim Yusuf, DPh, MD; TRANSCEND (Telmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease) Investigators
Mann JF, Schmieder RE, Dyal L, McQueen MJ, Schumacher H, Pogue J, et al. Effect of Telmisartan on Renal Outcomes: A Randomized Trial. Ann Intern Med. 2009;151:1-10. doi: 10.7326/0003-4819-151-1-200907070-00122
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Published: Ann Intern Med. 2009;151(1):1-10.
Angiotensin-receptor blockers (ARBs) blunt progression of advanced diabetic nephropathy, but their long-term renal effects in other patients are not clear.
To examine the long-term renal effects of telmisartan versus placebo in adults at high vascular risk.
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.
Multicenter, multinational study.
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.
Telmisartan, 80 mg/d (nÂ = 2954), or matching placebo (nÂ = 2972) plus standard treatment for a mean of 56 months.
Composite renal outcome of dialysis or doubling of serum creatinine, changes in estimated glomerular filtration rate (GFR), and changes in albuminuria.
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]; PÂ = 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]; PÂ = 0.031). Albuminuria increased less with telmisartan than with placebo (32% [CI, 23% to 41%] vs. 63% [CI, 52% to 76%]; PÂ < 0.001). Decreases in estimated GFR were greater with telmisartan than with placebo (mean change in estimated GFR, âˆ’3.2 mL/min per 1.73 m2 [SD, 18.3] vs. âˆ’0.26 mL/min per 1.73 m2 [SD, 18.0]; PÂ < 0.001).
Only 17 participants had dialysis.
In adults with vascular disease but without macroalbuminuria, the effects of telmisartan on major renal outcomes were similar to those of placebo.
Few trials have evaluated whether angiotensin-receptor blockers (ARBs) prevent renal disease in people without proteinuria.
In this trial, patients with cardiovascular disease or diabetes, but without macroalbuminuria or heart failure, were randomly assigned to receive telmisartan or placebo. During 4 to 5 years of follow-up, telmisartan recipients had albuminuria less often but had doubling of serum creatinine and slight decreases in estimated glomerular filtration rate more often than placebo recipients. Few patients in either group required dialysis.
The effects of ARBs on renal variables are complicated, but no strong evidence indicates that they prevent clinically important renal disease in patients without proteinuria.
All participants received randomized therapy and were followed, except for 18 (0.3%) who were followed until the end of the study or until a primary event occurred. The number of patients considered for the trial who did not enter the run-in phase is unknown. A figure showing trial follow-up and cardiovascular outcomes is published elsewhere (1). Progression of proteinuria was defined as new microalbuminuria, macroalbuminuria, or both. eGFR = estimated glomerular filtration rate; UACR = urinary albumin–creatinine ratio.
There were no significant differences between groups (see Table 1 for details). HR = hazard ratio.
Regression analysis demonstrated that a change in systolic blood pressure of 10 mm Hg is associated with a change in estimated GFR of 2.05 mL/min per 1.73 m2. GFR = glomerular filtration rate.
Some 95% CIs exceed the scale of relative risk and are shown by the numbers in parentheses. P values for interaction test whether there is an interaction of the respective subgroup with the 2 treatment methods. Diabetes is defined as having a history of diabetes or a fasting glucose level >7 mmol/L (>126 mg/dL). eGFR = estimated glomerular filtration rate; UACR = urinary albumin–creatinine ratio.
The treatment–subgroup interaction term was significant (P = 0.006). See Appendix Figure 1. UACR = urinary albumin–creatinine ratio.
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