ONTARGET (telmisartan with ramipril)
Trial question
Is a combination of telmisartan and ramipril superior to ramipril in patients with vascular disease or high-risk diabetes?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
27.0% female
73.0% male
N = 17078
17078 patients (4581 female, 12497 male).
Inclusion criteria: patients with vascular disease or high-risk diabetes without HF.
Key exclusion criteria: known hypersensitivity or intolerance to angiotensin 2 receptor antagonist or angiotensin-converting enzyme; symptomatic congestive HF; renal artery stenosis; hepatic dysfunction.
Interventions
N=8502 combination therapy (80 mg telmisartan and 10 mg ramipril per day).
N=8576 ramipril (at a dose of 10 mg per day).
Primary outcome
Composite of CV death, MI, stroke or hospitalization for heart failure
16.3%
16.5%
16.5 %
12.4 %
8.3 %
4.1 %
0.0 %
Combination
therapy
Ramipril
No significant
difference ↔
No significant difference in CV death, MI, stroke or hospitalization for HF (16.3% vs. 16.5%; RR 0.99, 99% CI 0.92 to 1.07).
Secondary outcomes
No significant difference in revascularization (15.3% vs. 14.8%; RR 1.04, 95% CI 0.97 to 1.13).
No significant difference in hospitalization for angina (11.2% vs. 10.8%; RR 1.04, 95% CI 0.95 to 1.14).
Significant increase in renal impairment (13.5% vs. 10.2%; RR 1.33, 95% CI 1.22 to 1.44).
Safety outcomes
No significant difference in angioedema and cough.
Significant differences in hypotensive symptoms (4.8% vs. 1.7%), syncope (0.3% vs. 0.2%).
Conclusion
In patients with vascular disease or high-risk diabetes without HF, combination therapy was not superior to ramipril with respect to the composite of CV death, MI, stroke or hospitalization for HF.
Reference
ONTARGET Investigators, Yusuf S, Teo KK et al. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med. 2008 Apr 10;358(15):1547-59.
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