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Lessons from ONTARGET
V Berlaimont1, J-M Billiouw, C Brohet
1Medical Department, Boehringer-Ingelheim, Brussels, Belgium.
Abstract:
The recently published results of the ONTARGET trial shed a new light on the cardiovascular protection of patients at high risk of a cardiovascular event. Despite a number of trials looking at the efficacy of Angiotensin Converting Enzyme inhibitors (ACEis) or Angiotensin Receptor Blockers (ARBs) in the prevention of cardiovascular events in patients with specific high risk profiles, the question of the equivalence of ACEis and ARBs remained unanswered. The ONTARGET trial has shown that telmisartan 80 mg administered for a median duration of 4.5 years to patients at high risk of developing a major cardiovascular event, is equally effective to ramipril 10 mg. In addition, telmisartan was slightly better tolerated. The comparator ramipril has been chosen as it is currently the gold standard ACEi since the results of the HOPE study, in terms of the composite outcome of cardiovascular death, myocardial infarction and stroke. Moreover, ONTARGET is the first trial to test the hypothesis of superiority of adding an ARB (telmisartan 80 mg) to an ACEi (ramipril 10 mg) over the ACEi ramipril monotherapy in cardiovascular protection of the same broad range of high-risk patients. Surprisingly, despite a more pronounced blood pressure lowering, the combination of the two agents did not lead to an additional decrease in the number of events, but had significantly more side-effects compared to ramipril monotherapy. ONTARGET is a landmark study, performed according to the highest statistical and clinical standards, providing compelling evidence and clear answers to two important clinical questions.
Insights
The ONTARGET trial found telmisartan equally effective as ramipril for cardiovascular protection in high-risk patients. Combination therapy did not improve outcomes but increased side effects, showing ramipril monotherapy is preferred.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- Previous trials evaluated Angiotensin Converting Enzyme inhibitors (ACEis) or Angiotensin Receptor Blockers (ARBs) for cardiovascular event prevention.
- The comparative efficacy and safety of ACEis versus ARBs remained unclear.
- Ramipril, a gold standard ACEi, was the comparator in this study.
Purpose of the Study:
- To determine the cardiovascular equivalence of telmisartan (an ARB) and ramipril (an ACEi) in high-risk patients.
- To investigate the superiority of combining telmisartan with ramipril versus ramipril monotherapy for cardiovascular protection.
Main Methods:
- The ONTARGET trial enrolled high-risk patients for cardiovascular events.
- Participants received telmisartan 80 mg or ramipril 10 mg for a median of 4.5 years.
- A subset received combination therapy of telmisartan 80 mg plus ramipril 10 mg.
Main Results:
- Telmisartan 80 mg demonstrated equal efficacy to ramipril 10 mg in reducing major cardiovascular events.
- Telmisartan showed a slightly better tolerability profile compared to ramipril.
- The combination of telmisartan and ramipril did not provide additional cardiovascular benefit over ramipril monotherapy and resulted in more side effects.
Conclusions:
- Telmisartan is an effective alternative to ramipril for cardiovascular protection in high-risk individuals.
- Combining ARBs and ACEis does not offer added cardiovascular benefits and increases adverse events.
- Ramipril monotherapy remains a preferred treatment strategy for this patient population.
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