In adults with vascular disease but without macroalbuminuria, the effects of telmisartan on major renal outcomes were similar to those of placebo, according to an analysis of the TRANSCEND trial published July 7 in the Annals of Internal Medicine.
Angiotensin-receptor blockers (ARBs) blunt progression of advanced diabetic nephropathy, however, the researchers noted that their long-term renal effects in other patients are not clear. As a result, Johannes F.E. Mann, MD, from Schwabing General Hospital and KfH Kidney Center, Ludwig Maximilians University in Munich, Germany, and colleagues examined the long-term renal effects of telmisartan (Micardis from Boehringer Ingelheim) versus placebo in adults at high vascular risk in the TRANSCEND (Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease) trial.
In the multicenter, multinational TRANSCEND trial, patients were randomly assigned by a central automated system between November 2001 and May 2004 and were followed until March 2008. The researchers enrolled 5,927 adults with known cardiovascular disease or diabetes with end-organ damage but without macroalbuminuria or heart failure, who could not tolerate angiotensin-converting enzyme (ACE) inhibitors.
The participants received telmisartan, 80 mg/d (2,954), or matching placebo (2,972) plus standard treatment for a mean of 56 months.
During four to five years of follow-up, Mann and colleagues found “no important difference” in the composite renal outcome with telmisartan (58 patients [1.96 percent]) versus placebo (46 patients [1.55 percent]).
Among the telmisartan and placebo groups, the authors reported that seven and 10 patients had dialysis and 56 and 36 patients had doubling of serum creatinine, respectively. Albuminuria increased less with telmisartan than with placebo (32 vs. 63 percent). Decreases in estimated glomerular filtration rate (GFR) were greater with telmisartan than with placebo (mean change in estimated GFR, –3.2 mL/min per 1.73 m2 vs. –0.26 mL/min per 1.73 m2).
As a study limitation, the investigators noted that only 17 participants had dialysis.
Based on their findings, Mann and colleagues concluded that 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. Also, the study provides no data supporting an expectation of ARB-associated improvement in renal outcomes in patients with vascular disease, but no nephropathy.
The Ingelheim, Germany-based Boehringer Ingelheim provided the primary funding source for the study.