TRANSCEND
Trial question
What is the role of telmisartan in patients intolerant to ACEIs with CVD or diabetes?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 5926
5926 patients (2547 female, 3379 male).
Inclusion criteria: patients intolerant to ACEIs with CVD or diabetes with end-organ damage.
Key exclusion criteria: symptomatic congestive HF; uncontrolled hypertension on treatment; renal artery stenosis; hepatic dysfunction; proteinuria.
Interventions
N=2954 telmisartan (at a dose of 80 mg/day).
N=2972 placebo (matching placebo).
Primary outcome
Composite of CV death, MI, stroke, or hospitalization for heart failure
15.7%
17%
17.0 %
12.8 %
8.5 %
4.3 %
0.0 %
Telmisartan
Placebo
No significant
difference ↔
No significant difference in CV death, MI, stroke, or hospitalization for HF (15.7% vs. 17%; HR 0.92, 95% CI 0.81 to 1.05).
Secondary outcomes
Significant decrease in CV death, MI, or stroke (13% vs. 14.8%; HR 0.87, 95% CI 0.76 to 1).
Significant decrease in hospitalization for cardiovascular cause (30.3% vs. 33%; RR 0.92, 95% CI 0.85 to 0.99).
No significant difference in revascularization procedures (11.8% vs. 13.1%; HR 0.9, 95% CI 0.77 to 1.03).
Safety outcomes
Significant difference in discontinuation of study drug due to hypotensive symptoms (0.98% vs. 0.54%).
Conclusion
In patients intolerant to ACEIs with CVD or diabetes with end-organ damage, telmisartan was not superior to placebo with respect to the composite of CV death, MI, stroke, or hospitalization for HF.
Reference
Telmisartan Randomised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (TRANSCEND) Investigators, S Yusuf, K Teo et al. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial. Lancet. 2008 Sep 27;372(9644):1174-83.
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