"Comparing Angiotensin Receptor Blockers and ACE Inhibitors for Patients with Vascular Disease or High-Risk Diabetes".The New England Journal of Medicine. 2008. 358(15):1547-1559.
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In patients with vascular disease or high-risk diabetes without heart failure, how do angiotensin receptor blockers compare with angiotensin-converting enzyme inhibitors in reducing mortality and morbidity from cardiovascular causes?
Telmisartan is equivalent to ramipril in patients with vascular disease or high-risk diabetes in terms of reducing mortality and morbidity from cardiovascular causes but is associated with less angioedema. The combination of the two drugs was associated with more adverse events without an increase in benefit.
Angiotensin-converting enzyme (ACE) inhibitors are beneficial in patients with heart failure, left ventricular dysfunction, vascular disease, or high-risk diabetes. Angiotensin receptor blockers (ARBs) have been proposed as an alternative due to possible increased effectiveness and fewer side effects like angioedema and cough.
Current guidelines may not have fully incorporated the results of this trial at the time of its publication, typically emphasizing the role of ACE inhibitors in this patient population.
Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET), multicenter, double-blind, parallel-group, randomized, controlled trial.
25,620 patients with coronary, peripheral, cerebrovascular disease, or diabetes with end-organ damage.
- Ramipril group (n=8576): Received 10 mg of Ramipril per day. - Telmisartan group (n=8542): Received 80 mg of Telmisartan per day. - Combination therapy (n=8502): Received both drugs.
- Primary: Composite of death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for heart failure. - Secondary: Death from cardiovascular causes, myocardial infarction, or stroke.
- Use of a run-in period could have selected patients more likely to tolerate both medications, potentially influencing outcomes. - No definitive benefit observed with additional blood-pressure lowering, raising questions about possible harm with full-dose multi-drug blockade of the renin-angiotensin system.
Supported by Boehringer Ingelheim, the Heart and Stroke Foundation of Ontario, and a Senior Scientist Award from the Canadian Institutes of Health Research.
ClinicalTrials.gov number, NCT00153101.