ARB treatment of high CV risk patients

Clinical Question

In patients with heart disease or advanced diabetes, does the use of angiotensin-receptor blocker treatment prevent the development of renal failure?

Bottom Line

Treatment with telmisartan -- and, by extrapolation, other angiotensin-receptor blockers -- does not prevent the development of chronic renal disease in patients with cardiovascular disease or with diabetes and other end-organ damage. Yes, it decreases the development of albuminuria, but that is not a useful predictor of subsequent renal failure, at least in this patient population. (LOE = 1b)

Reference

Mann JF, Schmieder RE, Dyal L, et al, for the TRANSCEND (Telmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease) Investigators. Effect of telmisartan on renal outcomes. A randomized trial. Ann Intern Med 2009;151(1):1-10.  [PMID:19451556]

Study Design

Randomized controlled trial (double-blinded)

Funding

Industry

Allocation

Concealed

Setting

Outpatient (any)

Synopsis

The researchers conducting this study enrolled 5926 patients with documented cardiovascular disease or diabetes with end-organ damage who could not tolerate angiotensin-converting enzyme inhibitor treatment. The patients received either placebo or telmisartan 80 mg per day for an average 4.75 years (allocation was concealed). Blood pressure was aggressively controlled in both groups, though patients receiving telmisartan had significantly lower blood pressure, on average. Approximately 10 percent of the patients had microalbuminuria and 1.4% had macroalbuminuria. Intention-to-treat analysis was not used; only patients completing the study were included in the analysis, which may not be of concern since fewer than 0.5% of the patients were lost to follow-up. After an average of almost 5 years, the incidence of albuminuria -- both micro and macro -- was lower in the telmisartan-treated group, though the incidence of the composite outcome of dialysis or doubling of serum creatinine was not different between the 2 groups (1.96% vs 1.55%; P = .2). One caveat: although the study was large, the number of events -- dialysis or creatinine doubling -- was small, and the study may not have been powerful enough to find a difference if one truly exists.