A combination of telmisartan and ramipril increased renal outcomes in vascular disease or diabetes

Randomized controlled trial (Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial [ONTARGET]).

Concealed.*

Blinded (clinicians, patients, and {outcome assessors}†).*

Median 56 months.

{733 centers in 40 countries.}†

25 620 patients ≥ 55 years of age who had established atherosclerotic vascular disease or diabetes with end-organ damage. At baseline, mean serum creatinine level was 94 µmol/L, mean estimated glomerular filtration rate (eGFR) was 74 mL/min/1.73 m², and mean urine albumin–to–creatinine ratio (UACR) was 0.82 mg/mmol. Exclusion criteria included major renal artery stenosis, uncorrected volume or sodium depletion, serum creatinine level > 265 µmol/L, and uncontrolled hypertension.

Telmisartan, 80 mg/d, plus ramipril, 10 mg/d (n = 8502), telmisartan (n = 8542), or ramipril (n = 8576).

Composite endpoint of dialysis, doubling of serum creatinine level, and death; and changes in eGFR level and UACR.

99.8% (intention-to-treat analysis).

The combination therapy group had a higher incidence of the composite endpoint than did the ramipril group; the telmisartan and ramipril groups did not differ (Table). The combination therapy and telmisartan groups had greater reductions in eGFR and smaller increases in UACR than did the ramipril group (Table).

Telmisartan and ramipril did not differ, but their combination increased adverse renal outcomes in patients at high risk for vascular events or diabetes.